Comparability studies of hemin from two different origins porcine and bovine in the production of Haemophilus influenzae type b (Hib) polysaccharide
Publication date: Available online 4 August 2020Source: BiologicalsAuthor(s): Suresh Beri, Darshan Gandhi, Pankaj Sharma, Dattatraya Gundpatil, Sunil Goel, Sunil Gairola (Source: Biologicals)
Source: Biologicals - August 5, 2020 Category: Biology Source Type: research

Comparison of bacterial endotoxin testing methods in purified pharmaceutical water matrices
Publication date: Available online 2 August 2020Source: BiologicalsAuthor(s): Marine Marius, Frédéric Vacher, Thierry Bonnevay (Source: Biologicals)
Source: Biologicals - August 2, 2020 Category: Biology Source Type: research

Transferability study of the BINACLE (binding and cleavage) assay for in vitro determination of botulinum neurotoxin activity
Publication date: Available online 29 July 2020Source: BiologicalsAuthor(s): Heike A. Behrensdorf-Nicol, Ursula Bonifas, Jolanta Klimek, Kay-Martin Hanschmann, Brigitte G. Dorner, Christine Hohenadl, Lars Töllner, Birgit Kegel, Beate Krämer (Source: Biologicals)
Source: Biologicals - July 31, 2020 Category: Biology Source Type: research

Designing peptide-based vaccine candidates for Plasmodium falciparum erythrocyte binding antigen 175
Publication date: Available online 25 July 2020Source: BiologicalsAuthor(s): Shakti Chauhan, Rajender Kumar, Nazam Khan, Swati Verma, Rakesh Sehgal, Praveen Kumar Tripathi, Umar Farooq (Source: Biologicals)
Source: Biologicals - July 25, 2020 Category: Biology Source Type: research

Aims and Scope/Editorial Board/Publishing Details
Publication date: July 2020Source: Biologicals, Volume 66Author(s): (Source: Biologicals)
Source: Biologicals - July 18, 2020 Category: Biology Source Type: research

A cross-industry forum on benchmarking critical quality attribute identification and linkage to process characterization studies
Publication date: Available online 11 July 2020Source: BiologicalsAuthor(s): Sarah Demmon, Swapnil Bhargava, Doreen Ciolek, Jennifer Halley, Nomalie Jaya, Marisa K. Joubert, Edward Koepf, Phillip Smith, Melody Trexler-Schmidt, Philip Tsai (Source: Biologicals)
Source: Biologicals - July 13, 2020 Category: Biology Source Type: research

Case study on the environmental monitoring for biological manufacturing using Time-lapse Shadow Image Analysis
Publication date: Available online 10 July 2020Source: BiologicalsAuthor(s): Shoji Narutaki, Ineui Lee, Yasuhito Sugawara, Kahei Akada, Akihiko Kondo (Source: Biologicals)
Source: Biologicals - July 12, 2020 Category: Biology Source Type: research

Report of the second international conference on next generation sequencing for adventitious virus detection in biologics for humans and animals
Publication date: Available online 11 July 2020Source: BiologicalsAuthor(s): Arifa S. Khan, Johannes Blümel, Dieter Deforce, Marion F. Gruber, Carmen Jungbäck, Ivana Knezevic, Laurent Mallet, David Mackay, Jelle Matthijnssens, Maureen O'Leary, Sebastiaan Theuns, Joseph Victoria, Pieter Neels (Source: Biologicals)
Source: Biologicals - July 12, 2020 Category: Biology Source Type: research

SARS-CoV-2: Virology, epidemiology, immunology and vaccine development
Publication date: Available online 23 June 2020Source: BiologicalsAuthor(s): Marc Baay, Bruno Lina, Arnaud Fontanet, Arnaud Marchant, Melanie Saville, Philippe Sabot, Philippe Duclos, Joris Vandeputte, Pieter Neels (Source: Biologicals)
Source: Biologicals - June 24, 2020 Category: Biology Source Type: research

Evaluation of a standardised Vi poly-l-lysine ELISA for serology of Vi capsular polysaccharide antibodies
Publication date: Available online 20 June 2020Source: BiologicalsAuthor(s): Peter Rigsby, Emma Beamish, Jason Hockley, Eleanor Atkinson, Krisztina Hitri, Elizabeth Jones, Jae Seung Yang, Firdausi Qadri, Novilia S. Bachtiar, Sean C. Elias, Akshay Goel, Ravipratapnarayan Mishra, Raju Dugyala, Marcela F. Pasetti, James E. Meiring, Maurice Mbewe, Melita A. Gordon, Andrew J. Pollard, Alastair Logan, Sjoerd Rijpkema (Source: Biologicals)
Source: Biologicals - June 21, 2020 Category: Biology Source Type: research

Induction of osteogenic differentiation by demineralized and decellularized bovine extracellular matrix derived hydrogels associated with barium titanate
Publication date: Available online 16 June 2020Source: BiologicalsAuthor(s): Danielle Luciana Aurora Soares do Amaral, Rafaella de Souza Salomão Zanette, Gustavo Torres de Souza, Silvioney Augusto da Silva, Jair Adriano Kopke de Aguiar, Raphael Fortes Marcomini, Antônio Márcio Resende do Carmo, Breno Valentim Nogueira, Rodolpho José da Silva Barros, Fernando de Sá Silva, Marcelo de Oliveira Santos, Michele Munk, Humberto de Mello Brandão, Carlos Magno da Costa Maranduba (Source: Biologicals)
Source: Biologicals - June 17, 2020 Category: Biology Source Type: research

Removal of the innocuity test from The International Pharmacopoeia and WHO recommendations for vaccines and biological products
Publication date: Available online 11 June 2020Source: BiologicalsAuthor(s): Dianliang Lei, Herbert Schmidt, Ivana Knezevic, Tiequn Zhou, Hye-na Kang, Sabine Kopp (Source: Biologicals)
Source: Biologicals - June 13, 2020 Category: Biology Source Type: research

Third human challenge trial conference, Oxford, United Kingdom, February 6–7, 2020, a meeting report
Publication date: Available online 4 June 2020Source: BiologicalsAuthor(s): Andrew J. Pollard, Robert Sauerwein, Marc Baay, Pieter Neels, on behalf of HCT3 speakers and session chairs, Shobana Balasingam, Philip Bejon, Nele Berthels, Susan Bull, Andrew Catchpole, Primus C. Chi, Roma Chilengi, Rebecca Cox, Hugh Davies, Anna Durbin, Kate Emary, Claudia Emerson, Robert Frenck, Olivia Grimwade, Marcia Hobbs, Gagandeep Kang (Source: Biologicals)
Source: Biologicals - June 4, 2020 Category: Biology Source Type: research

Potency evaluation of rabies vaccine for human use: The impact of reducing the number of animals per dilution – Part 2
Publication date: Available online 22 May 2020Source: BiologicalsAuthor(s): Nathalia S. Machado, Wildeberg C. Moreira, Jessica F. de S. Freitas, Antonio Eugenio C C de Almeida, Wlamir Correa de Moura (Source: Biologicals)
Source: Biologicals - May 23, 2020 Category: Biology Source Type: research

Aims and Scope/Editorial Board/Publishing Details
Publication date: May 2020Source: Biologicals, Volume 65Author(s): (Source: Biologicals)
Source: Biologicals - May 15, 2020 Category: Biology Source Type: research

Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019
Publication date: Available online 4 May 2020Source: BiologicalsAuthor(s): Isabelle Bekeredjian-Ding, Wim Van Molle, Marc Baay, Pieter Neels, Nele Berthels, Christoph Conrad, Angela van Diepen, Sarah Fortune, Karen Goetz, Andrew Gorringe, Daniel Hoft, Robert A. Johnson, Peter Kremsner, Oleg Krut, Yves Levy, Wolfram Metzger, Volker Oeppling, Scott Stibitz, Kawsar R. Talaat, Stephen Thomas (Source: Biologicals)
Source: Biologicals - May 5, 2020 Category: Biology Source Type: research

Another case of mistaken identity? Vaccinia virus in another live Camelpox vaccine
Publication date: Available online 22 April 2020Source: BiologicalsAuthor(s): Zack Saud, Tariq M. Butt (Source: Biologicals)
Source: Biologicals - April 23, 2020 Category: Biology Source Type: research

New paths for sustainable solutions to tackle global and emerging infectious threats
Publication date: Available online 20 April 2020Source: BiologicalsAuthor(s): Anja Holm (Source: Biologicals)
Source: Biologicals - April 20, 2020 Category: Biology Source Type: research

An investigation into gene copy number determination in transgenic yeast; The importance of selecting a reliable real-time PCR standard
Publication date: Available online 8 April 2020Source: BiologicalsAuthor(s): Roghayeh Shirvani, Mohammad Barshan-tashnizi, Maryam Shahali (Source: Biologicals)
Source: Biologicals - April 10, 2020 Category: Biology Source Type: research

The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019
Publication date: Available online 27 March 2020Source: BiologicalsAuthor(s): Hye-Na Kang, Robin Thorpe, Ivana Knezevic, Carolina Damas Rocha Zarate Blades, Mary Casas Levano, Jing Yin Chew, Mumbi Bernice Chilufya, Parichard Chirachanakul, Hui Ming Chua, Ali Vasheghani Farahani, Mariam Raouf Wefky Ghobrial, Suna Habahbeh, Hugo Hamel, Gi Hyun Kim, Violeta Perez Rodriguez, Desi Eka Putri, Jacqueline Rodgers, Maria Savkina, Oleh Semeniuk, Shraddha Srivastava (Source: Biologicals)
Source: Biologicals - March 27, 2020 Category: Biology 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
Publication date: Available online 26 March 2020Source: BiologicalsAuthor(s): Céline Desbrousses, Fabienne Archer, Adélie Colin, Alexandra Bobet-Erny, Angélique Champavère, Edwige Gros, Pascale Beurdeley, Stéphane Cruvellier, Florence Tardy, Marc Eloit (Source: Biologicals)
Source: Biologicals - March 26, 2020 Category: Biology Source Type: research

Obstacles to vaccination of animals and prospective solutions
Publication date: Available online 21 March 2020Source: BiologicalsAuthor(s): Anja Holm, Jeroen Kortekaas (Source: Biologicals)
Source: Biologicals - March 22, 2020 Category: Biology Source Type: research

Aims and Scope/Editorial Board/Publishing Details
Publication date: March 2020Source: Biologicals, Volume 64Author(s): (Source: Biologicals)
Source: Biologicals - March 17, 2020 Category: Biology Source Type: research

Content of anti-β-amyloid42 oligomers antibodies in multiple batches from different immunoglobulin preparations
Publication date: Available online 9 March 2020Source: BiologicalsAuthor(s): Xi Du, Zongkui Wang, Zhaoji Lv, Li Ma, Shengliang Ye, Fengjuan Liu, Rong Zhang, Haijun Cao, Changqing Li (Source: Biologicals)
Source: Biologicals - March 10, 2020 Category: Biology Source Type: research

A reliable assay for ensuring the biological activity of anti T lymphocyte immunoglobulin as an alternate to compendial flow cytometry method
Publication date: Available online 6 March 2020Source: BiologicalsAuthor(s): Subhash Chand, Utpreksha Vaish, Anu Sharma, Nripendra Nath Mishra, Jai Prakash Prasad, Richi V. Mahajan (Source: Biologicals)
Source: Biologicals - March 7, 2020 Category: Biology 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
Publication date: Available online 22 February 2020Source: BiologicalsAuthor(s): Megan H. Cleveland, Bharathi Anekella, Michael Brewer, Pei-Ju Chin, Heather Couch, Eric Delwart, Jim Huggett, Scott Jackson, Javier Martin, Serge Monpoeho, Tom Morrison, Siemon H.S. Ng, David Ussery, Arifa S. KhanAbstractAdventitious 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...
Source: Biologicals - February 23, 2020 Category: Biology 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 - February 21, 2020 Category: Biology Source Type: research

Immune globulin subcutaneous, human 20% solution (Xembify®), a new high concentration immunoglobulin product for subcutaneous administration
Publication date: Available online 19 February 2020Source: BiologicalsAuthor(s): William Alonso, Pete Vandeberg, John Lang, Jeffrey Yuziuk, Rebecca Silverstein, Kenya Stokes, Dennis McBride, Maria Cruz, Doug Burns, W. Keither Merritt, Todd Willis, Juan I. JorqueraAbstractImmune 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 Injection (Human),10% Caprylate/Chromatography Purified (I...
Source: Biologicals - February 19, 2020 Category: Biology Source Type: research

A next-generation sequencing based method for determining genetic stability in Clostridium tetani vaccine strains
Publication date: Available online 11 February 2020Source: BiologicalsAuthor(s): Jeroen L.A. Pennings, Eric Abachin, Sylvie Uhlrich, Raphaël Esson, Laurent Mallet, Rob J. VandebrielAbstractProduction 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...
Source: Biologicals - February 13, 2020 Category: Biology 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 - February 13, 2020 Category: Biology Source Type: research

Purification and in vivo stability and half-life of recombinant lipid modified staphylokinase
Publication date: Available online 6 February 2020Source: BiologicalsAuthor(s): Sheethal Thomas Mannully, V.P.B. Rekha, N. Singh, C. Shanthi, K.K. PulicherlaAbstractStaphylokinase (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...
Source: Biologicals - February 7, 2020 Category: Biology Source Type: research

Aims and Scope/Editorial Board/Publishing Details
Publication date: January 2020Source: Biologicals, Volume 63Author(s): (Source: Biologicals)
Source: Biologicals - January 30, 2020 Category: Biology Source Type: research

Establishment of the national reference standard for tetanus toxoid in Thailand
Publication date: Available online 23 January 2020Source: BiologicalsAuthor(s): Daraporn Pittayakhajonwut, Pannipa Ekthaicharern, Greanggrai Hommalai, Dissaya Lohavech, Rattana Jongkol, Indrajeet Poredi, Nadir Harjee, Assajun Amen, Apichai Suppasansathorn, Supaporn PhumiamornAbstractThe 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...
Source: Biologicals - January 23, 2020 Category: Biology 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 - January 23, 2020 Category: Biology 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.bovi...
Source: Biologicals - January 23, 2020 Category: Biology Source Type: research

Strategy and validation of a consistent and reproducible nucleic acid technique for mycoplasma detection in advanced therapy medicinal products
Publication date: Available online 22 January 2020Source: BiologicalsAuthor(s): Danilo D'Apolito, Lucia D'Aiello, Salvatore Pasqua, Lucia Pecoraro, Floriana Barbera, Bruno Douradinha, Giuseppina Di Martino, Chiara Di Bartolo, Pier Giulio ConaldiAbstractAdvanced 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 ...
Source: Biologicals - January 23, 2020 Category: Biology 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
Publication date: Available online 17 January 2020Source: BiologicalsAuthor(s): Meenu Wadhwa, Hye-Na Kang, Teeranart Jivapaisarnpong, Aziza Ahmed, Lucia Rizka Andalucia, Carolina Damas Rocha Zarate Blades, Mary Casas Levano, Weihong Chang, Jing Yin Chew, Mumbi Bernice Chilufya, Parichard Chirachanakul, Heeyoun (Gloria) Cho, Yi O. Cho, Kyung Min Choi, Sannie Chong, Hui Ming Chua, Ali Vasheghani Farahani, Mumun Gencoglu, Mariam Raouf Wefky Ghobrial, Prasunkumar GuhaAbstractThe first global workshop on implementation of the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products adop...
Source: Biologicals - January 18, 2020 Category: Biology Source Type: research

Acidic isoforms of Erwinase form part of the product: Correlation with clinical experience
Publication date: Available online 18 January 2020Source: BiologicalsAuthor(s): David GervaisAbstractErwinia chrysanthemi l-asparaginase (ErA) has been used for the treatment of acute lymphoblastic leukaemia (ALL) for decades, and its safety and efficacy have been well demonstrated. ErA drug substance and drug product contain a small proportion of acidic isoforms, with a known mechanism of formation, which have been shown to be minor conformational variants retaining enzymatic activity and function. Specifications for these acidic isoforms were set with an extremely limited data set, and with further manufacturing experien...
Source: Biologicals - January 18, 2020 Category: Biology Source Type: research

A highly sensitive internally-controlled real-time PCR assay for mycoplasma detection in cell cultures
Publication date: Available online 16 January 2020Source: BiologicalsAuthor(s): Julia Sung, J. Ross HawkinsAbstractMycoplasma contamination of cell lines is a common occurrence and may affect the cell line behaviour in a variety of ways. Contamination with mycoplasma is usually not obvious so cell lines should be frequently tested. Several commercially available kits for mycoplasma detection exist, however the Ph. Eur. culture method which can take several weeks to yield results is still considered to be the ‘gold standard’ method. There is therefore a need for rapid alternative methods with comparable sensitiv...
Source: Biologicals - January 17, 2020 Category: Biology Source Type: research

Development of a novel reporter gene assay for platelet-derived growth factor-BB bioactivity
Publication date: Available online 30 December 2019Source: BiologicalsAuthor(s): Anna Niu, Zhang Zhang, Xiaolin Wang, Jing Wang, Junjie Xu, Xin Su, Xiaopeng Zhang, Wei ChenAbstractPlatelet-derived growth factors (PDGFs) are involved in various physiological and pathological processes, making them important targets for drug development. However, current methods for measuring PDGF bioactivity do not meet the rapidly growing requirements of pharmaceutical research. Here, we describe a novel reporter gene assay (RGA) for PDGF-BB activity measurement. RGA was developed with engineered cells expressing a modified luciferase prot...
Source: Biologicals - December 31, 2019 Category: Biology Source Type: research

Isolation and characterization of phage (ETP-1) specific to multidrug resistant pathogenic Edwardsiella tarda and its in vivo biocontrol efficacy in zebrafish (Danio rerio)
Publication date: Available online 27 December 2019Source: BiologicalsAuthor(s): Chamilani Nikapitiya, H.P.S.U. Chandrarathna, S.H.S. Dananjaya, Mahanama De Zoysa, Jehee LeeAbstractEdwardsiella tarda phage (ETP-1) was isolated from marine fish farm water to characterize its effect against pathogenic multidrug-resistant E. tarda. According to transmission electron microscopy results, ETP-1 is classified as a member of the family Podoviridae. ETP-1 showed MOI dependent E. tarda growth inhibition, a latent period of 60 min, and burst size of 100 PFU per infected cells. In host range tests, five out of eight E. tarda...
Source: Biologicals - December 29, 2019 Category: Biology Source Type: research

Development of anti-drug monoclonal antibody panels against adalimumab and infliximab
Publication date: Available online 27 December 2019Source: BiologicalsAuthor(s): Takuo Suzuki, Minoru Tada, Akiko Ishii-WatabeAbstractThe generation of anti-drug antibodies (ADAs) is one of the most serious problems in therapy using monoclonal antibodies (mAbs), because ADAs can impact the pharmacokinetics, efficacy, and safety of mAbs. It is therefore important to detect the generated ADAs in patients. For the appropriate detection of ADAs, methods that detect various types of ADAs (e.g., low- and high-affinity ADAs) are needed, but since there are no adequate reference preparations of ADAs relevant to human ADAs in most ...
Source: Biologicals - December 27, 2019 Category: Biology Source Type: research

Overexpression of microRNA-375 and microRNA-122 promotes the differentiation of human induced pluripotent stem cells into hepatocyte-like cells
In this study, we evaluated the use of overexpression of microRNA-375 (miR-375) and miR-122 in differentiating the Human Induced Pluripotent Stem Cells (hiPSCs) into functional hepatocyte-like cells (HLCs) without growth factors. We also compared the differentiation by miRNAs versus growth factors. HiPSCs were divided into two main groups: 1- HiPSCs were induced using lentiviral overexpression of miR-375 to differentiate into definitive endoderm (DE) cells in seven days. Then lentiviral overexpression of miR-122 was applied to differentiate DE cells into HLCs in additional 14 days. 2- HiPSCs were differentiated into HLCs u...
Source: Biologicals - December 26, 2019 Category: Biology Source Type: research

The first World Health Organization International Standard for in vitro biological activity of darbepoetin
Publication date: Available online 18 December 2019Source: BiologicalsAuthor(s): Ben Cowper, Jason Hockley, Katherine Partridge, Jackie Ferguson, Peter Rigsby, Chris BurnsAbstractThe expiry of patents protecting the manufacture and sale of therapeutic darbepoetin products is expected to lead to the emergence of biosimilar products. In response to this, the first World Health Organization (WHO) International Standard (IS) for darbepoetin has been developed. A lyophilized preparation of darbepoetin, coded 17/204, was evaluated in an international collaborative study, the results of which suggest that the candidate preparatio...
Source: Biologicals - December 18, 2019 Category: Biology Source Type: research

Quality by Design approaches to assessing the robustness of tangential flow filtration for MAb
This article illustrates a case study of TFF robustness performed for a process characterization of a monoclonal antibody under QbD principles by exploring functional relationships that link the process parameters to quality/process attributes with prior process knowledge, risk assessment, and multivariate experiments. In every case of quality or process attributes, all measured values were in alignment with the allowable specification range, and the developed models were non-significant and had no lack of fit, thus confirming the robustness of the TFF process within the tested ranges of process parameters. (Source: Biologicals)
Source: Biologicals - December 15, 2019 Category: Biology Source Type: research

Brucella abortus S19 rfbD mutant is highly attenuated, DIVA enable and confers protection against virulent challenge in mice
In this study, rfbD gene deleted mutant S19 was developed. The mutant strain designated S19ΔR displayed rough LPS phenotype, which was confirmed by acriflavine dye-agglutination and LPS-SDS-PAGE analysis. The virulence was amply reduced as suggested by increased sensitivity to complement killing; reduction in splenic-bacterial load and the recovery time RT50 as validated in mice model. Anti-brucella humoral response was significantly lower as compared to S19 immunization. The minimal induction of Brucella specific IgG1, IgG2a & IgG2b, and IgG3 resulted in no apparent reactivity to RBPT antigen. S19ΔR showed...
Source: Biologicals - December 14, 2019 Category: Biology Source Type: research

Potent virucidal activity against Flaviviridae of a group IIA phospholipase A2 isolated from the venom of Bothrops asper
Publication date: Available online 12 December 2019Source: BiologicalsAuthor(s): Hebleen Brenes, Gilbert D. Loría, Bruno LomonteAbstractSecreted phospholipase A2 (sPLA2) molecules are small, calcium-dependent enzymes involved in many biological processes. Viperid venoms possess gIIA sPLA2s and sPLA2-like proteins, both having homology to human gIIA sPLA2, an innate immunity enzyme. We evaluated the antiviral action of Mt–I (catalytically-active sPLA2) and Mt-II (catalytically-inactive variant) isolated from the venom of Bothrops asper, against a diverse group of viruses. Yellow Fever and Dengue (enveloped) vir...
Source: Biologicals - December 13, 2019 Category: Biology Source Type: research

Pragmatic rules for comparability of biological medicinal products
Publication date: Available online 11 December 2019Source: BiologicalsAuthor(s): R. Martijn van der Plas, Marcel H.N. Hoefnagel, Hans L. Hillege, Kit C.B. RoesAbstractComparability is a key concept in the evaluation of both manufacturing changes and biosimilars. It constitutes a pragmatic and flexible approach which recognises that biologicals are inherently variable and that minor variations in quality attributes are often clinically irrelevant. In this discussion paper, we argue that comparability exercises rely on a number of pragmatic criteria. These criteria have been remarkably robust for 20 years of comparability ex...
Source: Biologicals - December 11, 2019 Category: Biology Source Type: research

Corrigendum to “Generation of acid resistant virus like particles of vaccine strains of foot-and-mouth disease virus (FMDV)” [Biologicals 60 (2019) 28–35]
Publication date: Available online 22 November 2019Source: BiologicalsAuthor(s): D.P.R. Selvaraj, P. Saravanan, J.K. Biswal, S.H. Basagoudanavar, H.J. Dechamma, V. Umapathi, B.P. Sreenivasa, R.P. Tamilselvan, N. Krishnaswamy, I. Zaffer, A. Sanyal (Source: Biologicals)
Source: Biologicals - November 23, 2019 Category: Biology Source Type: research

A class Ⅰ lentogenic newcastle disease virus strain confers effective protection against the prevalent strains
In this study, an NDV isolate APMV-1/Chicken/China (SC)/PT3/2016 (hereafter referred as PT3) was identified as a class Ⅰ NDV and a lentogenic strain. The antigenic relationship between PT3 and 3 other NDV strains, including vaccine strain LaSota and 2 prevalent genotype Ⅶd and Ⅵb strains were analyzed. The protective efficacy of PT3 and LaSota against challenge with genotype Ⅶd and Ⅵb strains were assessed. The antigenic analysis result showed that 4 strains belong to the single serotype and the PT3 antiserum exhibited the highest HI titer against 3 other NDV strains. The results of protective efficacy showed tha...
Source: Biologicals - November 19, 2019 Category: Biology Source Type: research