The potential markers of NK-92 associated to cytotoxicity against K562 cells.
Abstract Markers associated to NK cytolytic activity are in a great need to regulate NK cell immunotherapy products. We assume that biomarkers which response to cytolysis will change their transcription, expression or secretion. To find NK-92 indicator to cytolytic activity, we have evaluated the potential markers by quantifying the expression of well-known cytotoxicity functional molecules (cytokine IFN-γ, Granzyme B, perforin, CD69 and CD107a), and explored candidate markers by a sweeping transcription picture of NK-92 using a direct cytolysis model (incubation with K562). We found that IFN-γ secreti...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 12, 2020 Category: Biotechnology Authors: Song X, Xu C, Wu X, Zhao X, Fan J, Meng S Tags: Biologicals Source Type: research

Establishment of a low-tumorigenic MDCK cell line and study of differential molecular networks.
Abstract Influenza is an acute respiratory infection caused by the influenza virus, and vaccination against influenza is considered the best way to prevent the onset and spread. MDCK (Madin-Darby canine kidney) cells are typically used to isolate the influenza virus, however, their high tumorigenicity is the main controversy in the production of influenza vaccines. Here, MDCK-C09 and MDCK-C35 monoclonal cell lines were established, which were proven to be low in tumorigenicity. RNA-seq of MDCK-C09, MDCK-C35, and MDCK-W73 cells was performed to investigate the putative tumorigenicity mechanisms. Tumor-related ...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 11, 2020 Category: Biotechnology Authors: Ma GL, Qiao ZL, He D, Wang J, Kong YY, Xin XY, Wen FQ, Bao SJ, Ma ZR, Wang FS, Xie J, Hu YH Tags: Biologicals Source Type: research

Immunological cross-recognition and neutralization studies of Micrurus mipartitus and Micrurus dumerilii venoms by two therapeutic equine antivenoms.
nte B Abstract New world Coral snakes comprise 82 species of medical importance distributed from southeastern United States to Argentina. In Colombia, Micrurus mipartitus and M. dumerilii are responsible for most coral snakebite accidents. Although infrequent, the severity of these envenomings, as well as the limited information available on the neutralizing coverage of commercially available antivenoms, underscores the need to perform studies to assess the cross-neutralizing ability of these life-saving immunobiologicals. In the present work, we evaluated the cross-recognition and neutralization ability of two eq...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 11, 2020 Category: Biotechnology Authors: Rey-Suárez P, Lomonte B Tags: Biologicals Source Type: research

Critical aspects on traditional antivenom production processes and their optimization by factorial analysis.
Abstract Most antivenoms are produced by techniques developed over 50 years ago, with minor modifications. Herein we revise the core of traditional antivenom production processes aiming to optimize key determinants for both consistent antivenom production and the best balance between F(ab')2 quality and recovery. Factorial design analysis revealed that pepsin digestion of 1:3 saline diluted equine plasma for 60 min under pH: 3.20, 37 °C temperature and a 1:15 pepsin to protein ratio conditions, allowed to achieve maximal IgG to F(ab')2 conversion with minimal protein aggregate formation. Further down...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 7, 2020 Category: Biotechnology Authors: Zurbano BN, Tavarone E, Viacava BG, Dokmetjian JC, Cascone O, Fingermann M Tags: Biologicals Source Type: research

Report from the GHPP-BloodTrain inspection workshop in Harare the 20th to the 24th of May 2019.
t J Abstract During the training workshop on Inspection of Blood Establishments, which was hosted by the PEI GHPP BloodTrain in Harare from the 20th to the 24th of May 2019, participants from the National Regulatory Authorities from seven Sub-Sahara African countries presented their current experiences related to regulation and inspection of blood establishments in their respective countries. While in all seven countries regulation and inspection of conventional medicinal products manufacturer is performed, the regulatory situation of blood and blood components as well as inspection of blood establishments is stil...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 6, 2020 Category: Biotechnology Authors: Samukange WT, Klümpers V, Kafere C, Schuler F, Tirane FJ, Kabaso B, Chama D, Ejeh EA, Reinhardt J Tags: Biologicals Source Type: research

Stability of live attenuated classical swine fever cell culture vaccine virus in liquid form for developing an oral vaccine.
Abstract Classical swine fever (CSF) is an important viral disease of pigs and controlled by vaccination. Unorganised backyard and wild pigs are difficult to vaccinate by needle vaccination. Here we formulated liquid vaccines using an Indian CSF cell culture vaccine virus and four stabilisers and evaluated their stability at 4 °C, 25 °C and 37 °C up to 24 h for use as oral vaccine. The stabilisers were Lactalbumin hydrolysate-Trehalose, Lactalbumin hydrolysate-Trehalose-Gelatin, Lactalbumin hydrolysate-Lactose-Sucrose and Lactalbumin hydrolysate-Sucrose. The liquid vaccines, with or...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 1, 2020 Category: Biotechnology Authors: Pachauri R, Manu M, Vishnoi P, Om Preethi B, Tiwari AK, Dhar P Tags: Biologicals Source Type: research

Analytical and functional similarity of biosimilar ABP 798 with rituximab reference product.
u J Abstract ABP 798 is a biosimilar candidate to rituximab reference product (RP). This comprehensive analytical similarity assessment was designed to assess the structural and functional similarity of ABP 798, rituximab (US), and rituximab (EU) using sensitive state-of-the-art analytical techniques capable of detecting small differences in product attributes. The similarity assessment was performed to evaluate product quality attributes associated with Fab, Fab/Fc, and Fc domains, including those known to affect the mechanisms of action. ABP 798 has the same amino acid sequence and exhibits similar secondary and...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 1, 2020 Category: Biotechnology Authors: Seo N, Huang Z, Kuhns S, Sweet H, Cao S, Wikström M, Liu J Tags: Biologicals Source Type: research

A time-resolved fluoroimmunoassay for assessing rabies antibody titers in the sera of vaccinated human subjects.
Abstract Several studies have investigated the use of simple in vitro tests for the assessment of rabies antibody titers in serum samples from vaccinated human subjects, which would allow the effectiveness of rabies vaccination to be conveniently evaluated. To this end, a novel time-resolved fluoroimmunoassay (TRFIA) for the assessment of rabies antibody titers was established in this study for evaluating the effectiveness of protection against rabies. The TRFIA had a satisfactory limit of detection value (0.035 IU/mL) under optimal conditions. Additionally, the application of the TRFIA was demonstrated in 68 seru...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 28, 2020 Category: Biotechnology Authors: Bian L, Zhao H, He C, Fang H, Chen Z, Lin L, Ye K, Wu Y, Lin G Tags: Biologicals Source Type: research

Development of biotinylated polyclonal anti-ribonucleoprotein IgG for detection of rabies virus antigen by direct rapid immunohistochemical test.
We describe here the development of a biotinylated polyclonal antibody against Rabies lyssavirus (RABV) ribonucleoprotein (RNP) and its use as a primary reagent in dRIT. Anti-RNP polyclonal horse IgG was purified by ionic exchange chromatography followed by immunoaffinity column chromatography, and its affinity, diagnostic sensitivity, and specificity were evaluated. CNS samples (120) of suspected rabies cases in different animal species were tested by dRIT, with the positive (n = 14) and negative (n = 106) results confirmed by direct fluorescence antibody testing (dFAT). Comparing the results of dRIT a...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 25, 2020 Category: Biotechnology Authors: Castro BS, Guedes F, Fernandes ER, Koike G, Katz ISS, Chaves LB, Silva SR Tags: Biologicals Source Type: research

Optimized dose of synthetic analogues of Monophosphoryl lipid A as an effective alternative for formulating recombinant human papillomavirus vaccine.
In this study, female BALB/c mice were vaccinated by HPV vaccine formulated with synMPL and aluminum hydroxide gel in which the concentration of synMPL ranged from 0 to 100 μg/dose. Anti-HPV L1 VLP antibody was measured for each group through Indirect ELISA and compared with Cervarix and Gardasil vaccines as approved anti-HPV vaccines. SynMPL showed a concentration-dependent increase up to 50 μg/dose in the immunogenicity of the vaccine. Therefore, synMPL at concentration of 50 μg/dose was selected as optimum concentration. The GMT profiling of synMPL-formulated vaccine (named Papilloguard) and Cervarix was not st...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 25, 2020 Category: Biotechnology Authors: Azimi A, Heidarian S, Zamani H, Taleghani N, Dehghani M, Seyedjafari E Tags: Biologicals Source Type: research

Effect of change in cell substrate on the critical quality attributes of L-Zagreb Mumps vaccine manufactured using parallel plate bioreactor.
Abstract Leningrad-Zagreb strain of mumps vaccine virus was grown on two different cell substrates viz. MRC-5 cells and Vero cells besides its original cell substrate i.e. Chicken Embryo Cells. Homogeneous virus pools prepared from each set of experiments were then lyophilized as per standard in-house protocol. Critical Quality Attributes (CQAs) such as the titer of the bulk vaccine and potency and stability of the lyophilized vaccine were then estimated using the CCID50 method to understand the lyophilization losses and thermal losses respectively in the vaccine. Another CQA viz. the genetic homogeneity of t...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 24, 2020 Category: Biotechnology Authors: Muley R, Dhere R Tags: Biologicals Source Type: research

Summary of the WHO hearing on the development of product-specific reference materials for coagulation factor VIII and factor IX products.
y E Abstract In recent years, several modified recombinant factor (F) VIII and FIX therapeutics with extended half-life have been licensed internationally for the treatment of haemophilia. Safe and effective use of these products requires monitoring of factor activity in patient plasma. The potency of all FVIII and FIX products is currently assigned in International Units (IU) which anchors the relationship between potency labelling, dosing and clinical monitoring. However, varying degrees of discrepancies in factor activity assays are observed between and within the factor activity analytical methods (one-stage c...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 23, 2020 Category: Biotechnology Authors: Ovanesov MV, Williams SC, Nübling CM, Dodt J, Hilger A, Maryuningsih Y, Gray E Tags: Biologicals Source Type: research

Multiplex reverse transcriptase droplet digital PCR for the simultaneous quantification of four dengue serotypes: Proof of concept study.
In conclusion, these results demonstrate that it is possible to quantify RNA from four CYD serotypes with a multiplex RT-ddPCR assay in a single assay. PMID: 32843276 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - August 22, 2020 Category: Biotechnology Authors: Navarro Sanchez ME, Devard N, Houy C, Abachin E, Godard S, Esson R, Chareyre A, Nougarede N Tags: Biologicals Source Type: research

Modulated mesenchymal stromal cells improve skin wound healing.
This article will review research data and strategies that may increase MSC's therapeutic efficacy in aging and damaged skin. PMID: 32828641 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - August 20, 2020 Category: Biotechnology Authors: Liubaviciute A, Ivaskiene T, Biziuleviciene G Tags: Biologicals Source Type: research

AS3288802, a highly selective antibody to active plasminogen activator inhibitor-1 (PAI-1), exhibits long efficacy duration in cynomolgus monkeys.
Abstract Antibodies have strong affinity to their target molecules, a characteristic that is utilized in antibody drugs. For antibody drugs, target molecule specificity and long duration pharmacokinetics, along with strong affinity to the target molecule are important characteristics. Plasminogen activator inhibitor-1 (PAI-1) is one of the key regulators of the fibrinolysis system, and the benefits of PAI-1 activity inhibition have been widely reported for multiple thrombosis and fibrosis-related diseases. Here, we generated a novel antibody, AS3288802, with high selectivity for active PAI-1. AS3288802 exhibited p...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 19, 2020 Category: Biotechnology Authors: Kashiwagi R, Sato R, Masumoto M, Yoshino M, Tanaka H Tags: Biologicals Source Type: research

Decontamination efficacy of sodium hypochlorite solutions for poliovirus.
In conclusion, we demonstrated that a high level of virus reduction (>10 log10) can be achieved with sodium hypochlorite solutions with poliovirus in suspension and dried on surfaces. PMID: 32807609 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - August 14, 2020 Category: Biotechnology Authors: Orel I, Graf H, Riou P Tags: Biologicals Source Type: research

Processing bovine intestinal mucosa to active heparin removes spiked BSE agent.
Abstract Heparin is an anticoagulant sourced from animal tissues. In the 1990s, bovine-sourced heparin was withdrawn from the U.S. market due to a theoretical concern that the bovine spongiform encephalopathy (BSE) agent might contaminate crude heparin and spread to humans as variant Creutzfeldt-Jakob disease. Only porcine intestinal heparin is now marketed in the U.S. FDA has encouraged the reintroduction of bovine heparin. We applied a scaled-down laboratory model process to produce heparin as an active pharmaceutical ingredient (API) starting from bovine intestinal mucosa. The process consisted of two phases. T...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 6, 2020 Category: Biotechnology Authors: Andrews O, Bett C, Shu Q, Kaelber N, Asher DM, Keire D, Gregori L Tags: Biologicals Source Type: research

Comparability studies of hemin from two different origins porcine and bovine in the production of Haemophilus influenzae type b (Hib) polysaccharide.
Abstract Hemin is one of the critical components of medium required for growth of Haemophilus influenzae type b (Hib) organisms. It is important to have different sources of critical components to ensure continuous supply for commercial production. Regulatory bodies also recommend having multiple sources for critical components. Hemin is produced from animal blood and the main sources are porcine and bovine origin. The approved Hib vaccine of SIIPL used for immunization is produced using hemin obtained from porcine origin. The present work focuses on the comparison of the growth of organisms on a large scale using...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 4, 2020 Category: Biotechnology Authors: Beri S, Gandhi D, Sharma P, Gundpatil D, Goel S, Gairola S Tags: Biologicals Source Type: research

Comparison of bacterial endotoxin testing methods in purified pharmaceutical water matrices.
Abstract Current bacterial endotoxin testing systems can be labor-intensive and time-consuming, involving several manual pipetting steps. In our quality control laboratory, annually, we test about 15,000 samples of different grades of purified water, WFI and water samples taken to validate cleaning procedures for endotoxins. We are currently using the Kinetic-QCL™ assay which is a pharmacopeia method that provides reliable results. We compared this assay with another Limulus amebocyte lysate (LAL)-based assay (Endosafe®-MCS) and an alternative endpoint fluorescent recombinant Factor C (rFC) assay (ENDOZY...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 1, 2020 Category: Biotechnology Authors: Marius M, Vacher F, Bonnevay T Tags: Biologicals Source Type: research

Transferability study of the BINACLE (binding and cleavage) assay for in vitro determination of botulinum neurotoxin activity.
l;mer B Abstract The muscle-relaxing effects of the botulinum neurotoxin (BoNT) serotypes A and B are widely used in clinical and aesthetic medicine. The standard method for measuring the biological activity of pharmaceutical BoNT products is a mouse bioassay. In line with the European Directive 2010/63/EU, a replacement by an animal-free method would be desirable. Whereas the existing approved in vitro methods for BoNT activity measurements are product-specific and not freely available for all users, the "binding and cleavage" (BINACLE) assay could become a widely applicable alternative. This method qua...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2020 Category: Biotechnology Authors: Behrensdorf-Nicol HA, Bonifas U, Klimek J, Hanschmann KM, Dorner BG, Hohenadl C, Töllner L, Kegel B, Krämer B Tags: Biologicals Source Type: research

Designing peptide-based vaccine candidates for Plasmodium falciparum erythrocyte binding antigen 175.
In this study, an integrated approach was employed to identify promiscuous peptides of a well-defined sequence of erythrocyte binding antigen-175 and promiscuous peptides for HLA alleles were designed using bioinformatics tools. A peptide with 15 amino acids (ILAIAIYESRILKRK) was selected based on its high binding affinity score and synthesized. This promiscuous peptide was used as stimulating antigen in lymphoproliferative responses to evaluate the cellular immune response. It was observed this peptide evokes lymphoproliferative and cytokine responses in individuals naturally exposed to the malaria parasite. The intensity...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 24, 2020 Category: Biotechnology Authors: Chauhan S, Kumar R, Khan N, Verma S, Sehgal R, Tripathi PK, Farooq U Tags: Biologicals Source Type: research

A cross-industry forum on benchmarking critical quality attribute identification and linkage to process characterization studies.
Abstract Identification of Critical Quality Attributes (CQAs) and subsequent characterization in process development studies are the key elements of quality by design (QbD) for biopharmaceutical products. Since the inception of ICH Q8R2, several articles have been published on approaches to conducting CQA risk assessments as well as the application to process understanding. A survey was conducted by multiple companies participating in an International Consortium working group on the best practices for identifying CQAs with linkages to process characterization (PC) studies. The results indicate that the companies s...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 11, 2020 Category: Biotechnology Authors: Demmon S, Bhargava S, Ciolek D, Halley J, Jaya N, Joubert MK, Koepf E, Smith P, Trexler-Schmidt M, Tsai P Tags: Biologicals Source Type: research

Report of the second international conference on next generation sequencing for adventitious virus detection in biologics for humans and animals.
Neels P Abstract The IABS-EU, in association with PROVAXS and Ghent University, hosted the "2nd Conference on Next Generation Sequencing (NGS) for Adventitious Virus Detection in Human and Veterinary Biologics" held on November 13th and 14th 2019, in Ghent, Belgium. The meeting brought together international experts from regulatory agencies, the biotherapeutics and biologics industries, contract research organizations, and academia, with the goal to develop a scientific consensus on the readiness of NGS for detecting adventitious viruses, and on the use of this technology to supplement or replace/substit...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 10, 2020 Category: Biotechnology Authors: Khan AS, Blümel J, Deforce D, Gruber MF, Jungbäck C, Knezevic I, Mallet L, Mackay D, Matthijnssens J, O'Leary M, Theuns S, Victoria J, Neels P Tags: Biologicals Source Type: research

Case study on the environmental monitoring for biological manufacturing using Time-lapse Shadow Image Analysis.
In this study, the superior rapidity and accuracy were indicated for reference strains and environmental microbial on both 90 mm plate and RODAC plate at 25-30 °C. Especially superior performance in the counting was observed for B.subtilis, P.aeruginosa and A.brasiliensis. The first and the median of colony detection speed for environmental microbial were 12 h and 26 h, respectively. The colony detection rate was 90% at 40 h incubation. Additionally, the characterization of swarming behavior was recognized based on time-lapse image acquisition data at 30 min intervals. This case study indi...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 10, 2020 Category: Biotechnology Authors: Narutaki S, Lee I, Sugawara Y, Akada K, Kondo A Tags: Biologicals Source Type: research

SARS-CoV-2: Virology, epidemiology, immunology and vaccine development.
Abstract This first International Alliance for Biological Standardization Covid-19 webinar brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable delegation from low- and middle-income countries, to discuss the virology, epidemiology and immunology of, and the vaccine development for SARS-CoV-2. PMID: 32600951 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - June 23, 2020 Category: Biotechnology Authors: Baay M, Lina B, Fontanet A, Marchant A, Saville M, Sabot P, Duclos P, Vandeputte J, Neels P Tags: Biologicals Source Type: research

Evaluation of a standardised Vi poly-l-lysine ELISA for serology of Vi capsular polysaccharide antibodies.
Abstract Typhoid vaccines based on protein-conjugated capsular Vi polysaccharide (TCVs) prevent typhoid in infants and young children. Analysis of the serum anti-Vi IgG response following immunisation against typhoid confirms the immunogenicity of TCVs and forms an important part of the pathway to licensing. Comparative studies could expedite the licencing process, and the availability of a standardised ELISA method alongside the 1st International Standard (IS) 16/138 for anti-typhoid capsular Vi polysaccharide IgG (human) will facilitate this process. To this end, a non-commercial ELISA based on a coat of Vi and ...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 20, 2020 Category: Biotechnology Authors: Rigsby P, Beamish E, Hockley J, Atkinson E, Hitri K, Jones E, Yang JS, Qadri F, Bachtiar NS, Elias SC, Goel A, Mishra R, Dugyala R, Pasetti MF, Meiring JE, Mbewe M, Gordon MA, Pollard AJ, Logan A, Rijpkema S, anti-Vi IgG working group Tags: Biologicals Source Type: research

Induction of osteogenic differentiation by demineralized and decellularized bovine extracellular matrix derived hydrogels associated with barium titanate.
In conclusion, bovine bone ECM hydrogel combined with BTNP presented and increased expression of markers of osteogenic differentiation in the absence of chemical inducing factors. PMID: 32561214 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - June 16, 2020 Category: Biotechnology Authors: Luciana Aurora Soares do Amaral D, de Souza Salomão Zanette R, Torres de Souza G, Augusto da Silva S, Adriano Kopke de Aguiar J, Fortes Marcomini R, Márcio Resende do Carmo A, Valentim Nogueira B, José da Silva Barros R, de Sá Silva F, de Oliveira San Tags: Biologicals Source Type: research

Removal of the innocuity test from The International Pharmacopoeia and WHO recommendations for vaccines and biological products.
Abstract The innocuity test was indicated as a quality control test to release pharmaceutical and biological products to the market. The test was intended to detect possible extraneous toxic contaminants derived from the manufacturing processes of the product. The test was included in WHO Recommendations and Guidelines for vaccines, biotherapeutics and blood products and in some monographs on antibiotics in The International Pharmacopoeia. Over the past years, the requirements in WHO Recommendations/Guidelines for conducting the test evolved such that it could be waived for routine release of product once consiste...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 11, 2020 Category: Biotechnology Authors: Lei D, Schmidt H, Knezevic I, Zhou T, Kang HN, Kopp S Tags: Biologicals Source Type: research

Third human challenge trial conference, Oxford, United Kingdom, February 6-7, 2020, a meeting report.
, Levine MM, McShane H, Oguti B, Openshaw P, Osowicki J, Parker M, Ploin D, Porter C, Roestenberg M, Selgelid MJ, Wildfire A Abstract The third Human Challenge Trial Meeting brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable delegation from Low- and Middle-Income Countries. Controlled human infection models (CHIMs) can be helpful to study pathogenesis and for the development of vaccines. As challenge agents are used to infect healthy volunteers, ethical considerations include that the challenge studies need to be safe and results ...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 3, 2020 Category: Biotechnology Authors: Pollard AJ, Sauerwein R, Baay M, Neels P, HCT3 speakers and session chairs, Balasingam S, Bejon P, Berthels N, Bull S, Catchpole A, Chi PC, Chilengi R, Cox R, Davies H, Durbin A, Emary K, Emerson C, Frenck R, Grimwade O, Hobbs M, Kang G, Kaye P, Le Doare Tags: Biologicals Source Type: research

Potency evaluation of rabies vaccine for human use: The impact of reducing the number of animals per dilution - Part 2.
Abstract The most critical parameter for the quality control of the rabies vaccine is potency, which is evaluated by challenge test in mice while using a large animal number. Because the 3Rs concept is applied worldwide, it becomes necessary to develop alternative methods to demonstrate the production consistency of these vaccines and reduce the number of animals used for performing assays. Hence, the present study evaluated the impacts of reducing the number of mice used in the NIH test for such vaccines. A retrospective data analysis compared vaccines tested in the standard test with the results of the reduced t...
Source: Biologicals : Journal of the International Association of Biological Standardization - May 22, 2020 Category: Biotechnology Authors: Machado NS, Moreira WC, Freitas JFS, Almeida AECC, Moura WC Tags: Biologicals Source Type: research

Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019.
kubu BN Abstract Controlled human infection models can be helpful to study pathogenesis and immune responses as a basis for the development of vaccines. In controlled human infection models, human challenge agents are used to infect healthy volunteers, therefore, ethical considerations include that the exposure studies need to be safe and results should be meaningful, e.g. contribute to a better cure. Both in the US and in Europe, the level of Good Manufacturing Practice required is related to the phase of the study ('sliding scale Good Manufacturing Practice'), and, hence, is much more open to speedy drug develop...
Source: Biologicals : Journal of the International Association of Biological Standardization - May 4, 2020 Category: Biotechnology Authors: Bekeredjian-Ding I, Van Molle W, Baay M, Neels P, PEI speakers and session chairs, Conrad C, van Diepen A, Fortune S, Goetz K, Gorringe A, Hoft D, Johnson RA, Kremsner P, Krut O, Levy Y, Metzger W, Oeppling V, Stibitz S, Talaat KR, Thomas S, Wildfire A, Y Tags: Biologicals Source Type: research

Another case of mistaken identity? Vaccinia virus in another live Camelpox vaccine.
In this study, we demonstrate that yet another high passage, live attenuated vaccine, comprising a different strain of Camelpox virus, contains genomic sequences that match a differing strain of Vaccinia virus. These results are discussed in the context of hypotheses put forward to explain the unknown origins of Vaccinia virus, suggesting further studies to elucidate evolutionary trajectories of Orthopoxviruses through passaging. PMID: 32334926 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Association of Biological Standardization)
Source: Biologicals : Journal of the International Association of Biological Standardization - April 22, 2020 Category: Biotechnology Authors: Saud Z, Butt TM Tags: Biologicals Source Type: research

New paths for sustainable solutions to tackle global and emerging infectious threats.
Abstract With the dramatic background of a newly emerged virus (SARS-CoV-2) spreading around the world, Coronavirus and other infectious health threats for the human and animal populations were illustrated and debated in excellent presentations at the IABS meeting 26-28 of February 2020. Historical evidence of pandemics and lessons learned from recent epidemics or epizootics caused by many pathogens (e.g., Ebola, Zika, and African Swine Fever viruses) illustrated the overarching need for close international cooperation. New and old technologies in vaccine development and their use were presented, resulting in a ca...
Source: Biologicals : Journal of the International Association of Biological Standardization - April 20, 2020 Category: Biotechnology Authors: Holm A Tags: Biologicals Source Type: research

An investigation into gene copy number determination in transgenic yeast; The importance of selecting a reliable real-time PCR standard.
Abstract Nowadays, Pichia pastoris is a well-known yeast for the production of recombinant proteins. The yield of protein production tightly depends on the copy number of the gene of interest into the host chromosome. Real-time PCR has been used as a high throughput method for molecular detection of gene copy number. In light of determining an absolute gene copy number, the reliability of the qPCR quantification standard is a major issue and it can be a potential source of errors in the final results. Since the literature on this issue is inconclusive, we set out to find a reliable quantification method that allow...
Source: Biologicals : Journal of the International Association of Biological Standardization - April 8, 2020 Category: Biotechnology Authors: Shirvani R, Barshan-Tashnizi M, Shahali M Tags: Biologicals Source Type: research

The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019.
This article describes the progress made and the regulatory landscape changes for biosimilars in 21 countries during the past ten years. Based on the information from regulators and from publicly available data, the following has been identified: 1) WHO guidelines have contributed to setting the regulatory framework for biosimilars in countries and increasing regulatory convergence at global level; 2) terminology used for biosimilars is more consistent than in the past; 3) biosimilars are now approved in all participating countries; and 4) the dominant product class for candidate biosimilars under development is monoclonal...
Source: Biologicals : Journal of the International Association of Biological Standardization - March 27, 2020 Category: Biotechnology Authors: Kang HN, Thorpe R, Knezevic I, Survey participants from 19 countries Tags: Biologicals Source Type: research

High-Throughput Sequencing (HTS) of newly synthetized RNAs enables one shot detection and identification of live mycoplasmas and differentiation from inert nucleic acids.
oit M Abstract Mycoplasma contamination threatens both the safety of biologics produced in cell substrates as well as the quality of scientific results based on cell-culture observations. Methods currently used to detect contamination of cells include culture, enzymatic activity, immunofluorescence and PCR but suffer from some limitations. High throughput sequencing (HTS) can be used to identify microbes like mycoplasmas in biologics since it enables an unbiased approach to detection without the need to design specific primers to pre-amplify target sequences but it does not enable the confirmation of microbial inf...
Source: Biologicals : Journal of the International Association of Biological Standardization - March 26, 2020 Category: Biotechnology Authors: Desbrousses C, Archer F, Colin A, Bobet-Erny A, Champavère A, Gros E, Beurdeley P, Cruvellier S, Tardy F, Eloit M Tags: Biologicals Source Type: research

Obstacles to vaccination of animals and prospective solutions.
Abstract On the 17th of October 2019, a workshop was held at Wageningen Bioveterinary Research in Lelystad, the Netherlands, to discuss the obstacles to vaccination in the veterinary field. Participants from academia, OIE, FAO, EC, EMA, USDA, national regulatory and veterinary health authorities, and the animal health industry discussed how availability and access to animal vaccines can be improved not just in the EU and US but also in Low to Middle Income Countries (LMIC) across the world and agreed that this requires innovations in both the scientific and the regulatory field. The workshop called for engaging al...
Source: Biologicals : Journal of the International Association of Biological Standardization - March 21, 2020 Category: Biotechnology Authors: Holm A, Kortekaas J Tags: Biologicals Source Type: research

Content of anti- β-amyloid42 oligomers antibodies in multiple batches from different immunoglobulin preparations.
Content of anti-β-amyloid42 oligomers antibodies in multiple batches from different immunoglobulin preparations. Biologicals. 2020 Mar 09;: Authors: Du X, Wang Z, Lv Z, Ma L, Ye S, Liu F, Zhang R, Cao H, Li C Abstract Immunoglobulin preparations are one of the promising drugs for Alzheimer's disease (AD). Anti-β-amyloid (Aβ) oligomers antibodies in immunoglobulin preparations are considered to be critical for the therapeutic effect against Alzheimer's disease. However, the antibodies content in immunoglobulin preparations varies greatly. In order to determine which factor contributes to...
Source: Biologicals : Journal of the International Association of Biological Standardization - March 9, 2020 Category: Biotechnology Authors: Du X, Wang Z, Lv Z, Ma L, Ye S, Liu F, Zhang R, Cao H, Li C Tags: Biologicals Source Type: research

A reliable assay for ensuring the biological activity of anti T lymphocyte immunoglobulin as an alternate to compendial flow cytometry method.
Abstract The assay of Anti T lymphocyte immunoglobulin for final drug product testing is carried out using flow cytometry on Peripheral Blood Mononuclear Cells (PBMCs) as specified in European and British Pharmacopeia. An alternate assay was developed wherein the potency based quality control evaluation of Anti T lymphocyte immunoglobulin is carried out by measuring complement dependent cytotoxicity (CDC) using fluorescent resazurin dye. The reported bioassay was specific, linear (R2 = 0.98), precise (%GCV for repeatability was 3.54% and intermediate precision was 4.27%) and accurate with relative bias o...
Source: Biologicals : Journal of the International Association of Biological Standardization - March 6, 2020 Category: Biotechnology Authors: Chand S, Vaish U, Sharma A, Mishra NN, Prasad JP, Mahajan RV Tags: Biologicals Source Type: research

Report of the 2019 NIST-FDA workshop on standards for next generation sequencing detection of viral adventitious agents in biologics and biomanufacturing.
Abstract Adventitious virus testing assures product safety by demonstrating the absence of viruses that could be unintentionally introduced during the manufacturing process. The capabilities of next-generation sequencing (NGS) for broad virus detection in biologics have been demonstrated by the detection of known and novel viruses that were previously missed using the recommended routine assays for adventitious agent testing. A meeting was co-organized by the National Institute of Standards and Technology and the U.S. Food and Drug Administration on September 18-19, 2019 in Gaithersburg, Maryland, USA, to facilita...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 21, 2020 Category: Biotechnology Authors: Cleveland MH, Anekella B, Brewer M, Chin PJ, Couch H, Delwart E, Huggett J, Jackson S, Martin J, Monpoeho S, Morrison T, Ng SHS, Ussery D, Khan AS Tags: Biologicals Source Type: research

Towards rabies elimination in the Asia-Pacific region: From theory to practice.
The objective of the meeting was focused upon snowballing efforts towards achieving substantial progress in rabies prevention, control and elimination within Asia by 2030, and thereby to safeguard the Pacific region. Individual sessions focused upon domestic animal, wildlife and human vaccination; the production and evaluation of quality, safety and efficacy of existing rabies biologics; and the future development of new products. Participants reviewed the progress to date in eliminating canine rabies by mass vaccination, described supportive methods to parenteral administration by oral vaccine application, considered upda...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 20, 2020 Category: Biotechnology Authors: Rupprecht CE, Abela-Ridder B, Abila R, Amparo AC, Banyard A, Blanton J, Chanachai K, Dallmeier K, de Balogh K, Del Rio Vilas V, Ertl H, Freuling C, Hill R, Houillon G, Jakava-Viljanen M, Kasemsuwan S, Léchenet J, Nel L, Panichabhongse P, Rahman SA, Tanta Tags: Biologicals Source Type: research

Immune globulin subcutaneous, human 20% solution (Xembify ®), a new high concentration immunoglobulin product for subcutaneous administration.
Immune globulin subcutaneous, human 20% solution (Xembify®), a new high concentration immunoglobulin product for subcutaneous administration. Biologicals. 2020 Feb 18;: Authors: Alonso W, Vandeberg P, Lang J, Yuziuk J, Silverstein R, Stokes K, McBride D, Cruz M, Burns D, Merritt WK, Willis T, Jorquera JI Abstract Immune globulin subcutaneous, human 20% solution (IGSC-C 20%, Xembify®)-a new 20% immunoglobulin (IgG) liquid product for subcutaneous (SC) administration-has been developed by Grifols. The IGSC-C 20% formulation is based on knowledge acquired from the formulation of Immune Globulin I...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 18, 2020 Category: Biotechnology Authors: Alonso W, Vandeberg P, Lang J, Yuziuk J, Silverstein R, Stokes K, McBride D, Cruz M, Burns D, Merritt WK, Willis T, Jorquera JI Tags: Biologicals Source Type: research

Virus disinfection for biotechnology applications: Different effectiveness on surface versus in suspension.
In this study three liquid disinfectants, based on sodium hypochlorite, glutaraldehyde, or hydrogen peroxide/peroxyacetic acid, as well as one gaseous hydrogen peroxide-based disinfectant were investigated for inactivation of lipid enveloped and non-lipid enveloped model viruses, using suspension (for the liquid disinfectants) and carrier assay designs for their virucidal efficacy on surface. The results of these side-by-side investigations demonstrate that depending on the type of application, i.e. routine surface disinfection or decontamination of e.g. a contaminated bioreactor content, the most effective choice of disin...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 11, 2020 Category: Biotechnology Authors: Kindermann J, Karbiener M, Leydold SM, Knotzer S, Modrof J, Kreil TR Tags: Biologicals Source Type: research

A next-generation sequencing based method for determining genetic stability in Clostridium tetani vaccine strains.
Abstract Production of tetanus and other clostridial vaccines highly depends on the stable and reproducible production of high toxin levels. This creates a need to ensure the genetic stability of seed strains. We developed a two-stage method for improved assessment of the genetic stability of Clostridium seed strains. This method is based on next-generation sequencing (NGS) of strain DNA and mapping the sequence reads to a reference sequence. The output allows analysis of global genome consistency followed, if necessary, by detailed expert judgement of potential deviations at the gene level. The limit of detection...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 11, 2020 Category: Biotechnology Authors: Pennings JLA, Abachin E, Uhlrich S, Esson R, Mallet L, Vandebriel RJ Tags: Biologicals Source Type: research

Purification and in vivo stability and half-life of recombinant lipid modified staphylokinase.
Abstract Staphylokinase (SAK), the thrombolytic protein holds a significant position in treating cardiovascular diseases. However, the rapid clearance of this protein from blood circulation reduces its effective usage and as a strategy to increase the half-life of SAK, initial work focussed on lipid modification of SAK (LMSAK) in E. coli GJ1158. Effective purification of the modified protein achieved using the two step method of hydrophobic interaction chromatography in succession with size exclusion chromatography, indicated a better yield. The thrombolytic activity of purified LMSAK analysed in heated plasma aga...
Source: Biologicals : Journal of the International Association of Biological Standardization - February 5, 2020 Category: Biotechnology Authors: Mannully ST, Rekha VPB, Singh N, Shanthi C, Pulicherla KK Tags: Biologicals Source Type: research

Establishment of the national reference standard for tetanus toxoid in Thailand.
Abstract The use of reference materials is the basis of standardization and quality control of biologicals such as vaccines produced by different manufacturers and lot-to-lot consistency. The aim of this study was to establish a secondary local and national reference standard of adsorbed tetanus toxoid that can be used for tetanus toxoid vaccine potency testing. Concentrated bulk of tetanus toxoid was adjuvanted and aliquoted before lyophilization. Lyophilized product was tested for biological and physicochemical qualities, including moisture content, identity, appearance, antigen content, degree of adsorption, an...
Source: Biologicals : Journal of the International Association of Biological Standardization - January 22, 2020 Category: Biotechnology Authors: Pittayakhajonwut D, Ekthaicharern P, Hommalai G, Lohavech D, Jongkol R, Poredi I, Harjee N, Amen A, Suppasansathorn A, Phumiamorn S Tags: Biologicals Source Type: research

Comparison of accompanying proteins in different therapeutic human serum albumin preparations.
In this study, a non-targeted mass spectrometric approach was used for label-free quantification and comparison of different pharmaceutical albumin preparations. Haptoglobin and a few other proteins accounted for approximately 80% of the accompanying proteins in all products tested. Low abundance proteins were enriched by means of a combinatorial peptide ligand library (ProteoMiner, Bio-Rad). Significant differences between the amounts of several mainly low abundance proteins, such as complement factors, were observed indicating differences in the manufacturing processes of the pharmaceutical companies. The removal of the ...
Source: Biologicals : Journal of the International Association of Biological Standardization - January 21, 2020 Category: Biotechnology Authors: Mikkat S, Dominik A, Stange J, Eggert M Tags: Biologicals Source Type: research

Strategy and validation of a consistent and reproducible nucleic acid technique for mycoplasma detection in advanced therapy medicinal products.
Abstract Advanced therapy medicinal products (ATMP) are required to maintain their quality and safety throughout the production cycle, and they must be free of microbial contaminations. Among them, mycoplasma contaminations are difficult to detect and undesirable in ATMP, especially for immunosuppressed patients. Mycoplasma detection tests suggested by European Pharmacopoeia are the "culture method" and "indicator cell culture method" which, despite their effectiveness, are time consuming and laborious. Alternative methods are accepted, provided they are adequate and their results are comparabl...
Source: Biologicals : Journal of the International Association of Biological Standardization - January 21, 2020 Category: Biotechnology Authors: D'Apolito D, D'Aiello L, Pasqua S, Pecoraro L, Barbera F, Douradinha B, Di Martino G, Di Bartolo C, Conaldi PG Tags: Biologicals Source Type: research

A real-time PCR assay based on a specific mutation of PstS1 gene for detection of M. bovis strains.
In this study, specific primers and MGB probes were designed according to the mutation in PstS1 gene, and a sensitive, specific and rapid real-time PCR assay for M. bovis was established. Then the assay was used to detect M. bovis in simulation samples. The minimum detectable concentration is 101 copies for M. bovis DNA. The standard curve showed correlation coefficient between threshold cycle and PstS1 gene fragment copy number was 0.997 and slope is -3.144. The minimum detectable concentration is 101 cells/ml for simulation sample. In addition, M.bovis strain 93006, 14 clinical BCG stains and 7 clinical M.bovis stra...
Source: Biologicals : Journal of the International Association of Biological Standardization - January 21, 2020 Category: Biotechnology Authors: Ji L, Jiang Y, Li G, Zhao X, Wan K Tags: Biologicals Source Type: research

WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.
Cho HG, Cho YO, Choi KM, Chong S, Chua HM, Farahani AV, Gencoglu M, Ghobrial MRW, Guha P, Gutierrez Lugo MT, Ha SB, Habahbeh S, Hamel H, Hong Y, Iarutkin A, Jang H, Jayachandran R, Jivapaisarnpong T, Kang HN, Kim DY, Kim GH, Kim Y, Kwon HS, Larsen J, Lee AH, Lee J, Medvedeva K, Munkombwe Z, Oh I, Park J, Park J, Putri DE, Rodgers J, Ryu S, Savkina M, Schreitmueller T, Semeniuk O, Seo M, Shin YI, Shin J, Srivastava S, Song H, Song S, Tavares Neto J, Wadhwa M, Yamaguchi T, Youn HD, Yun M Abstract The first global workshop on implementation of the WHO guidelines on procedures and data requirements for changes to appr...
Source: Biologicals : Journal of the International Association of Biological Standardization - January 17, 2020 Category: Biotechnology Authors: Wadhwa M, Kang HN, Jivapaisarnpong T, WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Andalucia LR, Blades CDRZ, Casas Levano M, Chang W, Chew JY, Chilufya MB, Chirachanakul P, Tags: Biologicals Source Type: research