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 (IGIV-C 10%, ...
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. Th...
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 22, 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.bovis strain...
Source: Biologicals - January 22, 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 22, 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 sensitivity, spe...
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
