S.Typhi derived OmpC peptide conjugated with Vi-polysaccharide evokes better immune response than free Vi-polysaccharide in mice.
Abstract Salmonella typhi is a causative organism for typhoid fever. Free Vi capsular polysaccharide (Vi) is licensed for use as vaccine for typhoid fever in individuals 2 years of age and older, which has limited memory response. There is dire need of protein or peptide as conjugate partner with Vi polysaccharide to improve shortcomings of Vi vaccine. Prediction of immunogenic peptide was deduced by program T sites. Carbodiimide mediated conjugation of Vi polysaccharide with OmpCp was performed utilizing ADH as linker. Immune response of Vi-conjugates along with control group was tested in mice. Ig and IgG antibo...
Source: Biologicals : Journal of the International Association of Biological Standardization - October 9, 2019 Category: Biotechnology Authors: Haque S, Sengupta S, Gupta D, Bhan MK, Kumar R, Khan A, Jailkhani B Tags: Biologicals Source Type: research

Considering "clonality": A regulatory perspective on the importance of the clonal derivation of mammalian cell banks in biopharmaceutical development.
Considering "clonality": A regulatory perspective on the importance of the clonal derivation of mammalian cell banks in biopharmaceutical development. Biologicals. 2019 Oct 03;: Authors: Welch JT, Arden NS Abstract There has been much recent focus on the regulatory emphasis and the relative importance surrounding clonal derivation of mammalian production cell lines used in the manufacture of recombinant DNA-derived biopharmaceuticals. This interest has led to an ongoing discussion between regulators and industry on how this topic is evaluated and the role it plays in the development of a new...
Source: Biologicals : Journal of the International Association of Biological Standardization - October 3, 2019 Category: Biotechnology Authors: Welch JT, Arden NS Tags: Biologicals Source Type: research

Characterization of defective interfering (DI) particles of Pestedes petitsruminants vaccine virus Sungri/96 strain-implications in vaccine upscaling.
Abstract The present investigation deals with the characterization of defective interfering (DI) particles of Peste-des-petits ruminants (PPR) vaccine Sungri/96 strain generated as a result of high MOI in Vero cells. During the serial 10 passages, infectivity titres drastically reduced from 6.5 to 2.25 log10TCID50/ml at high MOI. Further, attenuation of CPE with high MOI indicated generation of DI particles that resulted in no/slow progression of CPE during the late passages. Monoclonal antibody based cell ELISA indicated normal protein (N & H) packaging in samples with DI activity. At genomic level, inconsist...
Source: Biologicals : Journal of the International Association of Biological Standardization - October 3, 2019 Category: Biotechnology Authors: Bora M, Yousuf RW, Dhar P, Manu M, Zafir I, Mishra B, Rajak KK, Singh RP Tags: Biologicals Source Type: research

Monoclonal antibody purification and its progression to commercial scale.
Abstract With the advancements in upstream technologies, the capacity for monoclonal antibody (mAb) production has transformed from a few milligrams to grams per liter. These titers lead to enormous pressure on downstream processes (DSPs), which need to be reworked to achieve higher efficiency and better utilization of available resources. Various parameters, such as column sizing, aggregate removal, filtration and volume handling, must be considered while designing a facility for commercial scale. If any of these critical parameters are not defined during the facility design stage, collapse of the process can res...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 23, 2019 Category: Biotechnology Authors: Chahar DS, Ravindran S, Pisal SS Tags: Biologicals Source Type: research

Method validation of Q-PCR detection of host residual DNA in antibody drug based on protein A magnetic beads.
Abstract The residual DNA derived from host cells in antibody drugs have potential safety risks. In this paper, the antibody in the test sample was removed by magnetic bead separation method, and the residual DNA were quantitatively determined by Q-PCR method. The residual DNA in the sample was analyzed according to the standard curve. We validated the species specificity, accuracy, precision, quantitative restrictions, reproducibility of this method. The results showed the linearrange was of 1 × 10-1~1 × 102 pg/μL and the curve linear was good, this method can specifically detect CHO ce...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 18, 2019 Category: Biotechnology Authors: Liu XZ, Zhang B, Zhao W, Li G, Zhou ML, Wei JS, Zhou JH, Gao J, Wang ZM Tags: Biologicals Source Type: research

Collaborative study for the calibration of the replacement International Standard for pertussis toxin for use in histamine sensitisation and CHO cell clustering assays.
Abstract Pertussis toxin (PT) in its detoxified form is one of the major protective antigens in vaccines against Bordetella pertussis (whooping cough). Reference preparations of native PT are required for the quality control of pertussis vaccines. Stocks of the first WHO International Standard (IS) for PT (JNIH-5) were low and a replacement was required. One candidate material was donated by a vaccine manufacturer to NIBSC. It was formulated, lyophilised into sealed glass ampoules and coded 15/126. An international collaborative study assessed the suitability of this material to replace JNIH-5. Fourteen laboratori...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 13, 2019 Category: Biotechnology Authors: Douglas-Bardsley A, Asokanathan C, Tierney S, Hockley J, Markey K Tags: Biologicals Source Type: research

Comparison of the liquid and lyophilized formulations of Prolastin ®-C for Alpha1-Antitrypsin deficiency: Biochemical characteristics, pharmacokinetics, safety and neoantigenicity in rabbits.
Comparison of the liquid and lyophilized formulations of Prolastin®-C for Alpha1-Antitrypsin deficiency: Biochemical characteristics, pharmacokinetics, safety and neoantigenicity in rabbits. Biologicals. 2019 Sep 12;: Authors: Arora V, Cruz M, Lang J, Klos AM, Merritt WK, Price J, Taylor G, Vandeberg P, Wee K, Willis T Abstract Multiple analytical and preclinical studies were performed to compare the biochemical characteristics, pharmacokinetics (PK), safety and neoantigenicity of a new 5% liquid formulation of Alpha-1 Proteinase Inhibitor (Liquid A1PI, Prolastin®-C Liquid) with the lyophilize...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 12, 2019 Category: Biotechnology Authors: Arora V, Cruz M, Lang J, Klos AM, Merritt WK, Price J, Taylor G, Vandeberg P, Wee K, Willis T Tags: Biologicals Source Type: research

Tetanus antitoxin potency assessment by surface plasmon resonance and ToBI test.
Abstract Potency testing of tetanus antitoxin must be performed in vivo, in a very painful, stressful and prone to high variability assay. It is, therefore, mandatory to find alternatives to this kind of potency assessment. Immunochemical tests as ELISA or ToBI test are already available but usually results in a poor correlation to the in vivo protection. Considering research and development of mono and oligoclonal antibodies against tetanus and the improvement of equine polyclonal antitoxin production and control, we developed an alternative instrumental test for tetanus antitoxin by using surface plasmon resonan...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 11, 2019 Category: Biotechnology Authors: Quintilio W, Kapronezai J, Takata DY, Marcelino JR, Moro AM Tags: Biologicals Source Type: research

Evaluation of carboxyl beads based latex agglutination test for rapid sero-diagnosis of Japanese encephalitis.
Abstract Japanese encephalitis (JE) is a major public health problem in the South Asian countries including India. Pigs serve as a relevant sentinel model, the surveillance of which could predict a potential JE outbreak in human population nearby. However, existing serological detection methods like Enzyme-Linked Immuno Sorbent Assay (ELISA), virus neutralization test (VNT) and Haemagglutination Inhibition (HI) require elaborative laboratory facilities which are invariably not available in field conditions. Recognizing the lacunae, attempts were made to develop recombinant antigen (rNS1) based latex agglutination ...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 10, 2019 Category: Biotechnology Authors: Grace MR, Chauhan J, Suman Kumar M, Kumar A, Bhilegaonkar KN, Singh M, Dhanze H Tags: Biologicals Source Type: research

Metabolic and proliferation evaluation of human adipose-derived mesenchymal stromal cells (ASC) in different culture medium volumes: standardization of static culture.
es JT Abstract Adipose-derived mesenchymal stromal/stem cells (ASC) have acquired a prominent role in tissue engineering and regenerative medicine. However, the standardization of basic culture procedures in this cellular type is still not well established according to the main qualitative cellular attributes. We evaluate the cell growth profile of human ASC in a different culture medium volumes and their nutritional composition utilizing static cultivation. Culture medium volumes (5, 10 and 15 mL/25 cm2) in T-flasks were evaluated by kinetic parameters and the metabolic composition was determined by biochemical...
Source: Biologicals : Journal of the International Association of Biological Standardization - September 5, 2019 Category: Biotechnology Authors: Simão VA, Evangelista-Ribeiro CP, Brand H, Lagass-Pereira L, Marques LF, Benites-Aoki PH, Nunes da Silveira-Antunes R, Tonso A, Ribeiro-Paes JT Tags: Biologicals Source Type: research

The new China vaccine administration law: Re-establishing confidence in vaccines.
PMID: 31477496 [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 30, 2019 Category: Biotechnology Authors: Huang B Tags: Biologicals Source Type: research

The duck EB66 ® cell substrate reveals a novel retrotransposon.
The duck EB66® cell substrate reveals a novel retrotransposon. Biologicals. 2019 Aug 29;: Authors: Perugi F, Freslon-Evain C, Batard L, Guillet P, Schwamborn K Abstract During the establishment of the duck EB66® cell line as a new cell substrate for vaccine production in industry, a very low level of reverse transcriptase (RT) activity was detected in the culture supernatant by product-enhanced RT assay but a whole battery of tests failed to evidence infectious particles. Results from extensive biochemical and physical testing demonstrated that RT activity was associated to an intracellular, n...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 29, 2019 Category: Biotechnology Authors: Perugi F, Freslon-Evain C, Batard L, Guillet P, Schwamborn K Tags: Biologicals Source Type: research

Evaluation of a capture antigen ELISA for the characterisation of tetanus vaccines for veterinary use.
Abstract We previously developed an ELISA assay for detection of tetanus toxoid antigen in tetanus vaccines for human use. Tetanus vaccines for veterinary use are qualitatively different to those used in humans, often containing a larger number and variety of non-tetanus antigens in the multi-valent products, and adjuvants that are not found in human vaccines. We assessed performance of the capture ELISA with a range of veterinary tetanus vaccines as a first step towards development of an immunoassay as a potential in vivo potency substitute. Nine tetanus vaccines were tested and all produced a good dose response ...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 27, 2019 Category: Biotechnology Authors: Riches-Duit R, Hassall L, Rigsby P, Stickings P Tags: Biologicals Source Type: research

A single immunogenicity assay for testing potency of combination DTaP vaccines: Simultaneous quantitation of anti-DT, anti-TT, anti-PTxd and anti-FHA antibodies in Guinea-pig serum with a Luminex ®-xMAP® bead-based serological assay.
A single immunogenicity assay for testing potency of combination DTaP vaccines: Simultaneous quantitation of anti-DT, anti-TT, anti-PTxd and anti-FHA antibodies in Guinea-pig serum with a Luminex®-xMAP® bead-based serological assay. Biologicals. 2019 Aug 23;: Authors: Bandiera S, Lebas A, Canizares-Martinello L, Guinchard F, Lyonnais C, Perrin S, Nicolas M, Uhlrich S, Chabaud-Riou M Abstract The diphtheria toxoid (DT), tetanus toxoid (TT), and acellular pertussis (aP) single immunogenicity assay (DTaP SIA) is a Luminex®-xMAP®-bead-based multiplex immunoassay for estimating the potency ...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 23, 2019 Category: Biotechnology Authors: Bandiera S, Lebas A, Canizares-Martinello L, Guinchard F, Lyonnais C, Perrin S, Nicolas M, Uhlrich S, Chabaud-Riou M Tags: Biologicals Source Type: research

Characterization of the viral genomes present in commercial batches of horse serum obtained by high-throughput sequencing.
Abstract Horses are often used as blood donors for commercial horse serum (HS) production and to manufacture biologicals. HS is an alternative for fetal bovine serum (FBS) used as a supplement for cell culture and vaccine production. Furthermore, HS is also frequently obtained in order to produce antisera toxins and pathogens. The advent of high-throughput sequencing (HTS) has promoted changes in virus detection, since previous knowledge of targets is not required. Thus, the present study aimed to describe the virome of five different batches of commercial HS from New Zealand (three batches) and Brazil and the Uni...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 23, 2019 Category: Biotechnology Authors: Paim WP, Weber MN, Cibulski SP, da Silva MS, Puhl DE, Budaszewski RF, Varela APM, Mayer FQ, Canal CW Tags: Biologicals Source Type: research

Qualification of a surface plasmon resonance assay to determine binding of IgG-type antibodies to complement component C1q.
Abstract Interaction of therapeutic antibodies with complement component C1q are frequently part of pharmaceutical characterization and production process comparability studies. Assays currently used to assess this interaction and/or the activation of the complement cascade are often cumbersome, time consuming or imprecise. We here report the further development, successful qualification and suitability evaluation of an SPR-based C1q binding assay for the characterization of IgG-C1q interactions. We evaluate different IgG subtypes and well-described mutants of IgG1. The assay offers a suitable alternative for exte...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 21, 2019 Category: Biotechnology Authors: Jovic M, Cymer F Tags: Biologicals Source Type: research

Development of a new 15-valent pneumococcal conjugate vaccine (PCV15) and evaluation of its immunogenicity.
In this study, we propose a new PCV15 candidate, in which the common 13 serotypes and a licensed control vaccine have equivalent efficacy while two additional serotypes showed adequate immunogenicity in the rabbit model. PMID: 31416790 [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 12, 2019 Category: Biotechnology Authors: Lee C, Choi SK, Kim RK, Kim H, Whang YH, Pharm H, Cheon H, Yoon DY, Kim CW, Baik YO, Park SS, Lee I Tags: Biologicals Source Type: research

Development of a novel chimeric PA-LF antigen of Bacillus anthracis, its immunological characterization and evaluation as a future vaccine candidate in mouse model.
In this study, we developed a recombinant PA-LF chimera antigen of Bacillus anthracis by fusing the PA domain 2-4 with lethal factor (LF) domain 1 and evaluated its protective potential against B. anthracis in mouse model. The anti-PA-LF chimera serum reacted with both PA and LF antigen, individually. The chimera elicited a strong antibody titer in mice with predominance of IgG1 isotype followed by IgG2b, IgG2a and IgG3. Cytokines were assessed in splenocytes of immunized mice and a significant up-regulation in the expression of IL-4, IL-10, IFN-γ and TNF-α was observed. The PA-LF chimera immunized mice exhibit...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 12, 2019 Category: Biotechnology Authors: Varshney A, Kumar M, Nagar DP, Pal V, Goel AK Tags: Biologicals Source Type: research

Diagnostics in the veterinary field: The role in health surveillance and disease identification.
k C Abstract An international workshop, held in Wiesbaden, Germany on 15-17 May 2019 provided an overview of existing and new methods and approaches to diagnostics in animal health and their benefits and challenges. The variability in quality and authority review of test kits across the world is a concern for the reliability of test results and the decisions that are based on the diagnostic data. In countries or regions without regulatory oversight, there is an urgent need for international harmonisation of quality requirements and licensing procedures. This would increase the validity of the diagnostic methods an...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 12, 2019 Category: Biotechnology Authors: Holm A, Hill R, Farsang A, Jungbäck C Tags: Biologicals Source Type: research

High-throughput LC-MS quantitation of cell culture metabolites.
In this study, we present a high-throughput LC-MS method with a 17-min cycle time that is capable of simultaneously monitoring 93 cell culture metabolites, including amino acids, nucleic acids, vitamins, sugars and others. This method has high precision and accuracy and has been successfully applied to the daily profiling of bioreactors and raw material qualification. Information obtained in these studies has been used to identify limiting amino acids during production, which guided adjustments to the feed strategy that prevented the potential misincorporation of amino acids. This type of metabolite profiling can be furt...
Source: Biologicals : Journal of the International Association of Biological Standardization - August 7, 2019 Category: Biotechnology Authors: Sun Z, Ji Q, Evans AR, Lewis MJ, Mo J, Hu P Tags: Biologicals Source Type: research

Establishing China's national standards of antigen content and neutralizing antibody responses for evaluation of SFTS vaccines.
Abstract Severe fever with thrombocytopenia syndrome (SFTS) is an acute infectious disease caused by severe fever with thrombocytopenia syndrome virus (SFTSV). SFTS is mainly characterized by severe fever with thrombocytopenia and has a high mortality rate. The virus has been found in China, South Korea, and Japan. Effective antiviral drugs or vaccines still have been unavailable. Now, two vaccine manufacturers in China are actively engaged in the development of the vaccine. To promote the development of SFTS vaccines and ensure their effective quality control, we developed national antigen and antibody references...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 26, 2019 Category: Biotechnology Authors: Li Y, Jia Z, Wu X, Wang L, Chen L, Dai X, Li X, Wang J Tags: Biologicals Source Type: research

Prescription-based prevalence of biological therapy in patients with psoriasis, rheumatoid arthritis, and inflammatory bowel diseases.
This study is based on data from IMS® Diagnosis Monitor and included patients who had received a biological drug in dermatology practices due to psoriasis (PSO), gastroenterology practices due to Crohn's disease (CD) or ulcerative colitis (UC), or rheumatology practices due to rheumatoid arthritis (RA) between April 2015 and December 2018. We analyzed 1,748,948 CD/UC-related prescriptions, 3,968,879 RA-related prescriptions, and 7,321,496 PSO-related prescriptions. Of these, 343,263 (19.6%) prescriptions for IBD, 92,343 (16.2%) prescriptions for RA, and 169,573 (6.9%) prescriptions for PSO were for biologicals. The pro...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 18, 2019 Category: Biotechnology Authors: Kostev K, Madelung M Tags: Biologicals Source Type: research

Utility of reference materials for Zika Virus nucleic acid testing.
Abstract The emergence of Zika virus (ZIKV) in the Americas has resulted in increased nucleic acid amplification testing (NAT) of clinical samples and blood donations. New molecular diagnostic assays have been developed resulting in a corollary requirement for ZIKV reference material. To address this we have produced and calibrated two African lineage ZIKV reference materials: a highly concentrated secondary standard (NIBSC: 16/110) and a lower concentration external quality control (QC) reagent (NIBSC: 16/124) and compared their performance in three ZIKV NAT assays in relation with the First International Standar...
Source: Biologicals : Journal of the International Association of Biological Standardization - July 2, 2019 Category: Biotechnology Authors: Kempster SL, Dougall T, Morris C, Gonzalez-Escobar G, Almond N, Anderson R Tags: Biologicals Source Type: research

Trabecular meshwork mesenchymal stem cell transplantation improve motor symptoms of parkinsonian rat model.
Abstract Stem cell transplantation is a new therapeutic strategy in the treatment of neurodegenerative disorders such as Parkinson's disease (PD). Therefore, in this study, the therapeutic effects of Trabecular Meshwork Mesenchymal Stem Cells (TM-MSCs) transplantation, as a new source of mesenchymal stem cells, were evaluated in the animal model of PD. After the development and confirmation of hemi-parkinsonian rats by administration of 6-hydroxy dopamine (6-OHDA) and apomorphine-induced rotation test, green fluorescent protein (GFP) labeled TM-MSCs (normal and induced cells) were transplanted in the striatum of r...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 29, 2019 Category: Biotechnology Authors: Mostafavi H, Ghassemifard L, Rostami A, Alipour M, Nadri S Tags: Biologicals Source Type: research

Achieving scientific and regulatory success in implementing non-animal approaches to human and veterinary rabies vaccine testing: A NICEATM and IABS workshop report.
Abstract This two-day workshop, co-sponsored by NICEATM and IABS-NA, brought together over 60 international scientists from government, academia, and industry to advance alternative methods for human and veterinary Rabies Virus Vaccine (RVV) potency testing. On day one, workshop presentations focused on regulatory perspectives related to in vitro potency testing, including recent additions to the European Pharmacopoeia (5.2.14) that provide a scientific rationale for why in vivo methods may be less suitable for vaccine quality control than appropriately designed in vitro methods. Further presentations reviewed the...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 26, 2019 Category: Biotechnology Authors: Poston R, Hill R, Allen C, Casey W, Gatewood D, Levis R, Mallet L, Smith D, Srinivas G, Stirling C, Allen D Tags: Biologicals Source Type: research

Self-reported satisfaction of patients receiving omalizumab for severe allergic asthma in Malta.
Abstract Treatment satisfaction is of utmost importance for ensuring adherence. Omalizumab is administered long-term if effective and well-tolerated in a hospital setting. The aim was to evaluate treatment satisfaction with omalizumab in Malta and to identify factors that may influence patients' satisfaction. A questionnaire was distributed to all asthmatic adult patients receiving omalizumab for at least one year. The questionnaire included demographic data, dosing regimen, asthma control test and the 14-item English version of the Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4. The TSQM 1...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 18, 2019 Category: Biotechnology Authors: Gouder C, Gouder S, Montefort S Tags: Biologicals Source Type: research

Generation of acid resistant virus like particles of vaccine strains of foot-and-mouth disease virus (FMDV).
Abstract Foot-and-mouth disease (FMD) is a contagious viral disease affecting cloven hoofed livestock. Insect cell expressed virus like particles (VLPs) are potential alternative to overcome the limitations of inactivated vaccine. However, at pH
Source: Biologicals : Journal of the International Association of Biological Standardization - June 17, 2019 Category: Biotechnology Authors: Deepak PR, Saravanan P, Biswal JK, Basagoudanavar SH, Dechamma HJ, Umapathi V, Sreenivasa BP, Tamilselvan RP, Krishnaswamy N, Zaffer I, Sanyal A Tags: Biologicals Source Type: research

Combining secukinumab and fingolimod to successfully treat ankylosing spondylitis and multiple sclerosis - A novel approach.
PMID: 31204079 [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 13, 2019 Category: Biotechnology Authors: Nisar MK Tags: Biologicals Source Type: research

Generic immune complex assay for detection of murine anti-drug-antibodies in complex with human IgG.
Abstract Rapid and versatile methods are needed for evaluation of immunogenicity in early safety studies. The present work presents a generic, simple and easy to use sandwich enzyme-linked immunosorbent assay for quasi-quantitative measurement of circulating immune complexes (CICs) formed by anti-drug antibodies (ADAs) in complex with human IgG in mouse plasma. The assay is suitable for evaluating the presence of in vivo formed CICs in mice exposed to human IgG antibodies independent of target and IgG subtype. The assay is established using commercially available antibodies, and calibrated using CIC mimics based o...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 11, 2019 Category: Biotechnology Authors: Boysen L, Sprinkel AME, Lauritzen B, Breinholt J, Lykkesfeldt J, Viuff BM, Landsy LH Tags: Biologicals Source Type: research

Evaluation of environment safety of a Japanese encephalitis live attenuated vaccine.
Abstract JE vaccination is the most effective and economical method of preventing JE. A live attenuated JE vaccine has been widely used in many countries since 1989, playing an important role in controlling JE outbreaks. However, whether the large-scale use of the live attenuated JE vaccine will lead to the dissemination of the vaccine virus in the environment and whether reversion of the neuroattenuation of the virus will occur during the transmission process remain major concerns for some researchers. To evaluate the transmission of a live attenuated JEV vaccine in mosquitoes and hosts, JE SA14-14-2 attenuated v...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 6, 2019 Category: Biotechnology Authors: Liu X, Jia L, Nie K, Zhao D, Na R, Xu H, Cheng G, Wang J, Yu Y, Li Y Tags: Biologicals Source Type: research

Octanorm [cutaquig ®], a new immunoglobulin (human) subcutaneous 16.5% solution for injection (165 mg/mL) - Biochemical characterization, pathogen safety, and stability.
Octanorm [cutaquig®], a new immunoglobulin (human) subcutaneous 16.5% solution for injection (165 mg/mL) - Biochemical characterization, pathogen safety, and stability. Biologicals. 2019 Jun 01;: Authors: Gelbmann N, Zöchling A, Pichotta A, Schmidt T, Murányi A, Ernegger T, Pock K, Römisch J Abstract Octanorm (marketed as cutaquig® in Canada and US [2018] and registered in several European countries [2019]) is a new immunoglobulin subcutaneous 16.5% liquid for the treatment of patients with primary immune deficiency (PID) and secondary immune deficiency (SID) depending on co...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 1, 2019 Category: Biotechnology Authors: Gelbmann N, Zöchling A, Pichotta A, Schmidt T, Murányi A, Ernegger T, Pock K, Römisch J Tags: Biologicals Source Type: research

Meeting report narcolepsy and pandemic influenza vaccination: What we know and what we need to know before the next pandemic? A report from the 2nd IABS meeting.
Abstract A group of scientific and public health experts and key stakeholders convened to discuss the state of knowledge on the relationship between adjuvanted monovalent inactivated 2009 influenza A H1N1 vaccines used during the 2009 influenza pandemic and narcolepsy. There was consensus that an increased risk of narcolepsy was consistently observed after Pandemrix (AS03-adjuvanted) vaccine, but similar associations following Arepanrix (AS03-adjuvanted) or Focetria (MF59-adjuvanted) vaccines were not observed. Whether the differences are due to vaccine composition or other factors such as the timing of large-scal...
Source: Biologicals : Journal of the International Association of Biological Standardization - May 23, 2019 Category: Biotechnology Authors: Edwards K, Hanquet G, Black S, Mignot E, Jankosky C, Shimabukuro T, Miller E, Nohynek H, Neels P Tags: Biologicals Source Type: research

The INN global nomenclature of biological medicines: A continuous challenge.
zzi M Abstract Medicines are assigned International Nonproprietary Names (INN) by the World Health Organization (WHO), pursuing the aim to increase patient safety. Following scientific developments in drug discovery and biotechnology, the number of biological medicines is constantly growing and a surge in INN applications for them has been observed. Pharmacologically active biological substances have a complex structure and mechanism of action posing new challenges in selecting names that appropriately reflect such properties. As a consequence, existing nomenclature naming schemes may need to be revised and new on...
Source: Biologicals : Journal of the International Association of Biological Standardization - May 23, 2019 Category: Biotechnology Authors: Robertson JS, Chui WK, Genazzani AA, Malan SF, López de la Rica Manjavacas A, Mignot G, Thorpe R, Balocco R, Rizzi M Tags: Biologicals Source Type: research

Quantitation of residual sodium dodecyl sulfate in meningococcal polysaccharide by gas chromatography-mass spectrometry.
Abstract Sodium dodecyl sulfate (SDS) is a commonly used surfactant in protein solubilization and also during the polysaccharide purification. A GC-MS method has been developed to quantitate residual SDS in meningococcal polysaccharide serogroups A,C,W,Y and X circumventing the need of spectroscopic assays and HPLC based methods which are either unstable or requires the confirmation by MS. The developed method is based on quantitative conversion of SDS to 1-dodecanol at elevated temperature. Meningococcal polysaccharides and SDS standards were treated with methanolic-HCl and extracted in n-Hexane. The conversion o...
Source: Biologicals : Journal of the International Association of Biological Standardization - May 21, 2019 Category: Biotechnology Authors: Shende N, Karale A, Marathe P, Chakraborty S, Mallya AD, Dhere RM Tags: Biologicals Source Type: research

The development and establishment of the 1st WHO BKV International Standard for nucleic acid based techniques.
We report on the evaluation of two lyophilised candidate cell culture derived, whole virus preparations, undertaken by 33 expert laboratories. By employing the principles of biological standardisation, we show improved agreement across laboratories, demonstrating the suitability of either candidate for use as a primary order calibrant. Candidate 14/212 was established by the WHO ECBS with an assigned potency of 7.2 log10 International Units/mL intended for the calibration of BKV secondary reference materials. PMID: 31105020 [PubMed - as supplied by publisher] (Source: Biologicals : Journal of the International Associa...
Source: Biologicals : Journal of the International Association of Biological Standardization - May 17, 2019 Category: Biotechnology Authors: Govind S, Hockley J, Morris C, Almond N, Collaborative Study Group Tags: Biologicals Source Type: research

Potency test to discriminate between differentially over-inactivated rabies vaccines: Agreement between the NIH assay and a G-protein based ELISA.
In this study we have generated several non-conform vaccine lots by an excessive inactivation with β-propiolactone (BPL) and assessed the capacity of both tests to detect the corresponding consequences. Excessive BPL inactivation causes G-protein unfolding, altering in turn viral morphology and the continuity of the G-protein layer in the viral particle. Both the NIH and the ELISA tests were able to monitor the consequences of excessive inactivation in a similar manner. Of note, the experimental error of the ELISA test was well below that of the NIH test. These results increase the prospect that the ELISA test could b...
Source: Biologicals : Journal of the International Association of Biological Standardization - May 17, 2019 Category: Biotechnology Authors: Toinon A, Moreno N, Chausse H, Mas E, Nicolai MC, Guinchard F, Jaudinaud I, Guinet-Morlot F, Riou P, Manin C Tags: Biologicals Source Type: research

Choice of parvovirus model for validation studies influences the interpretation of the effectiveness of a virus filtration step.
Abstract Different parvoviruses are used interchangeably as models in validation studies to demonstrate effective clearance of small viruses by filtration in the manufacturing of biotherapeutics. The aim of these experiments was to determine if filtration of different parvoviruses (canine parvovirus [CPV], minute virus of mice [MVM], and porcine parvovirus [PPV]) results in similar virus retention. While filtration with a Planova™ 20 N filter (mean pore size: 19 ± 2 nm) completely removed PPV and MVM from the filtrate (mean log reduction factors [LRFs] ≥5.8 to ≥7.3 log10), CPV was only p...
Source: Biologicals : Journal of the International Association of Biological Standardization - May 16, 2019 Category: Biotechnology Authors: Nowak T, Popp B, Roth NJ Tags: Biologicals Source Type: research

Cloning and expression of a novel synthetic gene containing VP1 and 3A in Bacillus subtilis as a vaccine candidate against foot-and-mouth disease virus.
In this study the bioinformatics characteristics of VP1 [141-160 and 23-42] and 3A [21-35] of Iranian serotypes O, A and Asia 1 was obtained using on-line predicting software. Then the sequence VP1 [141-160]-GS-VP1 [23-42]-GS-3A [21-35]-GS were codon-optimized and cloned onpHT43shuttle vector and finally expressed in Bacillus subtilis WB600 strain. We could predict VP1 [141-160] as a B cell epitope, VP1 [23-42] as a CTL epitope and 3A [21-35] as a Th cell epitope. The 20KD recombinant protein expressed by Bacillus subtilis were detected by SDS-PAGE. The results showed that this recombinant protein had epitope characteristi...
Source: Biologicals : Journal of the International Association of Biological Standardization - May 16, 2019 Category: Biotechnology Authors: Aghaei A, Moghbeli M, Kargar M, Nazarian S, Kafilzadeh F Tags: Biologicals Source Type: research

A strategic road map to filing a Biologics License Application for a pluripotent stem cell derived therapeutic product.
PMID: 31053443 [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 30, 2019 Category: Biotechnology Authors: Creasey AA, Stacey G, Bharti K, Sato Y, Lubiniecki A Tags: Biologicals Source Type: research

Immunoglobulin G from single plasma donor in immune globulin intravenous causes false positive pyrogen test.
Abstract A sudden, unprecedented failure of USP rabbit pyrogen tests for multiple 10% IGIV-C lots prompted a thorough investigation of the root cause for this phenomenon. All microbe-related testing, including Limulus amebocyte lysate test for endotoxin, proved negative, and no deficiencies were discovered in manufacturing. Plasma pool composition analysis revealed that a single plasma donor ("Donor X″) was common to all pyrogenic IGIV-C lots and that as little as one unit of "Donor X″ plasma (in a pool of ∼4500 units) was sufficient to cause IGIV-C lot failure in the USP rabbit pyrogen t...
Source: Biologicals : Journal of the International Association of Biological Standardization - April 22, 2019 Category: Biotechnology Authors: Zervos C, Zimmerman TP, Willis T, Flexman G, Srivastava J, Silverstein R, Williams M, Vandeberg P, Culp JL, Burns D, Barham V, Durham A, Malinzak DA Tags: Biologicals Source Type: research

Comparison of different immunization routes on the immune responses induced by Mycobacterium tuberculosis ESAT-6/CFP-10 recombinant protein.
Abstract According to some difficulties against tuberculosis (TB) vaccination, development of new TB vaccines has been noted in recent years. Selection of proper route for vaccination is one of the most important factors for induction of good immune responses. Hence, in this study, the effects of different administration routes, including intranasal (I.N), subcutaneous (S.C) and intramuscular (I.M) on immune responses against Mycobacterium tuberculosis ESAT-6/CFP-10 recombinant protein has been considered. Recombinant ESAT-6/CFP-10 protein with or without adjuvant (MF59 or cholera toxin B (CTB)) was administered b...
Source: Biologicals : Journal of the International Association of Biological Standardization - April 20, 2019 Category: Biotechnology Authors: Namvarpour M, Tebianian M, Mansouri R, Ebrahimi SM, Kashkooli S Tags: Biologicals Source Type: research

Use of a new RNA next generation sequencing approach for the specific detection of virus infection in cells.
Abstract The utilization of the current combination of in vitro, in vivo and PCR assays for the identification of adventitious viruses in production cells has a limited range of detection. While Next Generation Sequencing (NGS) has a broader breadth of detection, it is unable to differentiate sequences from replicating viruses versus background inert sequences. In order to improve NGS specificity, we have designed a new NGS approach which targets subsets of viral RNAs only synthesized during cell infection. In order to evaluate the performance of this approach for detecting low levels of adventitious viruses, we s...
Source: Biologicals : Journal of the International Association of Biological Standardization - April 13, 2019 Category: Biotechnology Authors: Brussel A, Brack K, Muth E, Zirwes R, Cheval J, Hebert C, Charpin JM, Marinaci A, Flan B, Ruppach H, Beurdeley P, Eloit M Tags: Biologicals Source Type: research

Correlation between the results of two analytical methods for measuring measles virus neutralizing antibodies in source plasma and therapeutic immunoglobulin products.
Abstract Patients with primary immunodeficiency disorders are vulnerable to infectious diseases. Intravenous immunoglobulin (IVIG) therapeutic products manufactured from human plasma are employed widely to protect patients from pathogens such as measles virus, which causes a potentially fatal and contagious disease. Therefore, health authorities stipulate a minimum titer of measles neutralizing antibodies (mnAbs) in IVIG products to ensure efficient protection. In general, mnAb titers are measured in a cell-based neutralization assay; however, this assay is labor intensive and time consuming, and the results are v...
Source: Biologicals : Journal of the International Association of Biological Standardization - April 13, 2019 Category: Biotechnology Authors: Hong J, Kim D, Won Y, Yoon J, Park KJ, Oh J, Kim CW Tags: Biologicals Source Type: research

Quality by Design characterization of the perfusion culture process for recombinant FVIII.
Abstract A Quality by Design (QbD) concept was applied to characterize a cell culture process for production of the recombinant Factor VIII (rFVIII). We characterized the production bioreactor process and defined the design space by applying risk assessment to determine potential critical process parameters (CPPs) impacting critical quality attributes (CQAs). Characterization studies were subsequently performed using a qualified scaled-down model (SDM) and a multi-factorial design of experiment (DOE) approach to determine both the individual and combined impacts of the potential CPPs on CQAs. Among the operating p...
Source: Biologicals : Journal of the International Association of Biological Standardization - March 26, 2019 Category: Biotechnology Authors: Kim YJ, Paik SH, Han SK, Lee S, Jeong Y, Kim JY, Kim CW Tags: Biologicals Source Type: research

Estimation of potency of Hepatitis B immunoglobulin marketed in India to evaluate the manufacturer's production consistency: Role of National Control Laboratory.
PMID: 30917901 [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 - March 25, 2019 Category: Biotechnology Authors: Meena J, Sood S, Rani N, Bisht R, Kiran M, Chhabra R, Singh S, Chand S Tags: Biologicals Source Type: research

Modifications of recombinant monoclonal antibodies in vivo.
Abstract Therapeutic recombinant monoclonal antibodies are subject to various modifications during cell culture, and to a lesser degree, during purification. These modifications are expected to remain relatively constant during storage with the protection of appropriate formulations. However, after administration to patients, the levels of modifications may vary over time in circulation, where the recombinant monoclonal antibodies are exposed to the physiological conditions. Scientific understanding of those in vivo modifications can help drug candidate selection to choose the most stable molecules and set appropr...
Source: Biologicals : Journal of the International Association of Biological Standardization - March 23, 2019 Category: Biotechnology Authors: Liu H, Nowak C, Patel R Tags: Biologicals Source Type: research

A new recombinant rabies virus expressing a green fluorescent protein: A novel and fast approach to quantify virus neutralizing antibodies.
Abstract The Rapid Fluorescent Focus Inhibition Test (RFFIT) is a standard assay used to detect and assess the titers of rabies virus neutralizing antibodies (RVNA) in blood sera. To simplify the multistep RFFIT procedure by eliminating the immunostaining step, we generated a new recombinant RV expressing a green fluorescent protein (rRV-GFP) and assess its suitability for quantifying RVNA. We rescued the rRV-GFP virus from plasmid DNA carrying a full-length genome of the CVS-N2c strain of RV in which the eGFP gene was inserted between the glycoprotein and RNA-polymerase genes. The recombinant virus was geneticall...
Source: Biologicals : Journal of the International Association of Biological Standardization - March 18, 2019 Category: Biotechnology Authors: Qin S, Volokhov D, Rodionova E, Wirblich C, Schnell MJ, Chizhikov V, Dabrazhynetskaya A Tags: Biologicals Source Type: research

Virus removal filtration of chemically defined Chinese Hamster Ovary cells medium with nanocellulose-based size exclusion filter.
This article investigates the virus removal capacity of nanocellulose-based filter for upstream bioprocessing of chemically defined Chinese hamster ovary (CHO) cells medium containing Pluronic F-68 (PowerCHO™, Lonza) and supplemented with insulin-transferrin-selenium (ITS) at varying process parameters. Virus retention was assessed by spiking ITS-supplemented PowerCHO™ medium with small-size ΦX174 phage (28 nm) as a surrogate for mammalian parvoviruses. The nanocellulose-based size exclusion filter showed high virus retention capacity (over 4 log10) and high flow rates (around 180 L m-2 h-1). The fi...
Source: Biologicals : Journal of the International Association of Biological Standardization - March 11, 2019 Category: Biotechnology Authors: Manukyan L, Padova J, Mihranyan A Tags: Biologicals Source Type: research

A structural in silico analysis of the immunogenicity of l-asparaginase from Escherichia coli and Erwinia carotovora.
This study showed that there are no significant differences in the level of immunogenicity between both enzymes, while asparaginase from E. coli presented a higher relative frequency of allergenic epitopes. These results are consistent with previously published reports. However, from a structural point of view, in our knowledge, this is the first research describing the structural antigenic determinants that contribute to the hypersensibility response to this treatment. PMID: 30871932 [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 - March 11, 2019 Category: Biotechnology Authors: Belén LH, Lissabet JB, de Oliveira Rangel-Yagui C, Effer B, Monteiro G, Pessoa A, Farías Avendaño JG Tags: Biologicals Source Type: research

Down-regulation of miR-122 after transplantation of mesenchymal stem cells in acute liver failure in mice model.
This study investigated the correlation between the hepatic level of miR-122 and the extent of liver tissue regeneration in CCl4 induced liver injury mice model following transplantation of menstrual blood-(MenSCs) and bone marrow-derived stem cells (BMSCs). Hepatic miR-122 levels were significantly up-regulated following administration of CCl4 (P 
Source: Biologicals : Journal of the International Association of Biological Standardization - February 26, 2019 Category: Biotechnology Authors: Fathi-Kazerooni M, Kazemnejad S, Khanjani S, Saltanatpour Z, Tavoosidana G Tags: Biologicals Source Type: research