Report of the international conference on manufacturing and testing of pluripotent stem cells
Publication date: Available online 24 August 2018Source: BiologicalsAuthor(s): Stewart Abbot, Francisca Agbanyo, Jan-Eric Ahlfors, Behnam A. Baghbaderani, Shirley Bartido, Kapil Bharti, Carl Burke, Bjorn Carlsson, Joy Cavagnaro, Abla Creasey, David DiGiusto, Kathy Francissen, Andrew Gaffney, Christopher Goldring, Thorsten Gorba, Elwyn Griffiths, Tadaaki Hanatani, Takao Hayakawa, Tatsuo Heki, Karin HoogendoornAbstractSessions included an overview of past cell therapy (CT) conferences sponsored by the International Alliance for Biological Standardization (IABS). The sessions highlighted challenges in the field of human pluri...
Source: Biologicals - August 25, 2018 Category: Biology Source Type: research
Calibration of the 7th British Working Standard for factors II, IX and X, concentrate
Publication date: Available online 24 August 2018Source: BiologicalsAuthor(s): Graham Roberts, Helen Wilmot, Thomas Dougall, Peter Rigsby, Elaine GrayAbstractSeven laboratories from 5 different countries participated in the calibration of the 7th British Working Standard (BWS) for blood coagulation factors II, IX and X. The candidate, 15/182, was assayed for Factors II and X potencies against the 4th International Standard (IS) for Factors II and X, Concentrate (11/126) and for Factor IX potency against the 5th IS for Factor IX, Concentrate (14/148). Intra-laboratory GCVs for all 3 factors were less than 10%, with the majo...
Source: Biologicals - August 24, 2018 Category: Biology Source Type: research
Re-evaluating the LD50 requirements in the codified potency testing of veterinary vaccines containing Leptospira (L.) serogroup Icterohaemorrhagiae and L. serogroup Canicola in the United States
Publication date: Available online 17 August 2018Source: BiologicalsAuthor(s): Angela Walker, Renee Olsen, Mindy Toth, Geetha SrinivasAbstractApproximately one-third of the reportable USDA Category D and E laboratory animals in the United States are expended on the potency testing of leptospiral vaccines by the codified hamster vaccination-challenge assay. Valid tests require ≥80% of challenge controls to succumb to disease and an LD50 between 10 and 10,000. This work evaluates the risk associated with the removal of LD50 limits; thereby, eliminating back-titration hamsters from in vivo potency assays for Leptospira (L.)...
Source: Biologicals - August 18, 2018 Category: Biology Source Type: research
Individual variability in humoral response of immunized outbred mice and cross-reactivity with prevalent Brazilian Neisseria meningitidis strains
Publication date: Available online 10 August 2018Source: BiologicalsAuthor(s): Gabriela Trzewikoswki de Lima, Elizabeth De Gaspari (Source: Biologicals)
Source: Biologicals - August 10, 2018 Category: Biology Source Type: research
Report of the international conference on next generation sequencing for adventitious virus detection in biologicals
Publication date: Available online 6 August 2018Source: BiologicalsAuthor(s): Arifa S. Khan, Luca Benetti, Johannes Blumel, Dieter Deforce, William M. Egan, Ivana Knezevic, Philip R. Krause, Laurent Mallet, Dietmar Mayer, Philip D. Minor, Pieter Neels, Guanhua WangAbstractA fundamental aspect of biological product safety is to assure absence of adventitious agents in the final product. Next-generation or high-throughput sequencing (NGS/HTS) has recently demonstrated detection of viruses that were previously missed using the recommended routine assays for adventitious agent testing of biological products. This meeting was c...
Source: Biologicals - August 7, 2018 Category: Biology Source Type: research
Proteome-wide identification of epitope-based vaccine candidates against multi-drug resistant Proteus mirabilis
Publication date: Available online 2 August 2018Source: BiologicalsAuthor(s): Nosheen Ehsan, Sajjad Ahmad, Syed Sikander Azam, Thanyada Rungrotmongkol, Reaz UddinAbstractProteus mirabilis is one of the important pathogens of urinary tract and exhibits resistance to multiple drugs. Development of vaccine tends to be the most promising and cost-effective remedy against the said pathogen. Herein, we implement a combinatorial approach for screening proteins harboring potential broad-spectrum antigenic epitopes in the proteome of P. mirabilis. The targets are host non-homologous, essential and virulent, and have localization in...
Source: Biologicals - August 2, 2018 Category: Biology Source Type: research
Baculovirus expression and purification of peste-des-petits-ruminants virus nucleocapsid protein and its application in diagnostic assay
Publication date: Available online 17 July 2018Source: BiologicalsAuthor(s): Suresh H. Basagoudanavar, Madhusudan Hosamani, D. Muthuchelvan, R.P. Singh, R. Santhamani, B.P. Sreenivasa, P. Saravanan, A.B. Pandey, R.K. Singh, Ramamurthy VenkataramananAbstractPeste-des-petits-ruminants (PPR) is a contagious and highly devastating disease of small ruminants. For control of endemic PPR, adequate supply of affordable and reliable diagnostics is critical for effective surveillance, along with the use of highly efficacious live vaccines that are currently available. The nucleocapsid (N) protein of PPR virus (PPRV) is an important ...
Source: Biologicals - July 18, 2018 Category: Biology Source Type: research
Successful slow tocilizumab desensitization in a patient with adult onset Still disease
Publication date: Available online 14 July 2018Source: BiologicalsAuthor(s): Tuba Erdogan, Nazife Sule Yasar Bilge, Timucin Kasifoglu (Source: Biologicals)
Source: Biologicals - July 14, 2018 Category: Biology Source Type: research
Development of screening method for intranasal influenza vaccine and adjuvant safety in preclinical study
Publication date: Available online 14 July 2018Source: BiologicalsAuthor(s): Yuki Hiradate, Eita Sasaki, Haruka Momose, Hideki Asanuma, Keiko Furuhata, Mamiko Takai, Taiki Aoshi, Hiroshi Yamada, Ken J. Ishii, Kentaro Tanemura, Takuo Mizukami, Isao HamaguchiAbstractRecently, many vaccine adjuvants have been developed; however, most of the newly developed adjuvants have been dropped out of preclinical and clinical trials owing to their unexpected toxicity. Thus, the development of highly quantitative and comparable screening methods for evaluating adjuvant safety is needed. In a previous study, we identified specific biomark...
Source: Biologicals - July 14, 2018 Category: Biology Source Type: research
Animal cell substrates for the production of biologicals: An introduction to WHO documents
Publication date: Available online 9 December 2014Source: BiologicalsAuthor(s): John Petricciani, Ivana Knezevic (Source: Biologicals)
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Human challenge trials in vaccine development, Rockville, MD, USA, September 28–30, 2017
The objective of this meeting was to examine the use of HCT, in response to the continuing human suffering caused by infectious diseases, preventable by the development of new and improved vaccines. For this, the approach of HCT could be valuable, as HCT can provide key safety, tolerability, immunogenicity, and efficacy data, and can be used to study host-pathogen biology. HCT can generate these data with speed, efficiency and minimal expense, albeit not with the same level of robustness as clinical trials. Incorporated wisely into a clinical development plan, HCT can support optimization or down-selection of new vaccine c...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Poly(lactic-co-glycolic acid)(PLGA)/TiO2 nanotube bioactive composite as a novel scaffold for bone tissue engineering: In vitro and in vivo studies
Publication date: May 2018Source: Biologicals, Volume 53Author(s): Hossein Eslami, Hamidreza Azimi Lisar, Tahereh Sadat Jafarzadeh Kashi, Mohammadreza Tahriri, Mojtaba Ansari, Tohid Rafiei, Farshid Bastami, Alireza Shahin-Shamsabadi, Fatemeh Mashhadi Abbas, Lobat TayebiAbstractThe aim of this study was to synthesize and characterize novel three-dimensional porous scaffolds made of poly (lactic-co-glycolic acid)/TiO2 nanotube (TNT) composite microspheres for bone tissue engineering applications. The incorporation of TNT greatly increases mechanical properties of PLGA/TNT microsphere-sintered scaffold. The experimental resul...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Identification of T cell and B cell epitopes against Indian HCV-genotype-3a for vaccine development- An in silico analysis
Publication date: May 2018Source: Biologicals, Volume 53Author(s): Varun Chauhan, Mini P. Singh, Radha K. RathoAbstractHepatitis C virus (HCV) infects almost 150 million people and is a leading cause of liver disease worldwide. It has been classified into seven genotypes; the most common genotype affecting Indian population is genotype 3 (60–70%). Currently there is no vaccine for any genotype of HCV. In order to develop peptide based vaccine against HCV, it is important to identify the conservancy in the circulating genotypes, along with the Human Leucocyte Antigen (HLA) alleles in the target population. The present stu...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Regulatory pathways to enable the licencing of alternatives to antibiotics
Publication date: May 2018Source: Biologicals, Volume 53Author(s): Faye Ioannou, Cindy Burnsteel, David K.J. Mackay, Cyril G. GayAbstractEffective alternatives to antibiotics (ATA) such as vaccines, antibodies, phage therapies, prebiotics, probiotics and herbal medicines can be used in place of traditional antibiotics in a way that does not compromise animal health as means of tackling the growing threat to both animal and human health from antimicrobial resistance (AMR). This paper reflects the key points on the approaches that were discussed during the 2nd International Symposium on ATA between regulatory agencies, veter...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Research on the advancement of standards and specifications of biologics in Korea
Publication date: May 2018Source: Biologicals, Volume 53Author(s): Ji-Young Son, Chang-Ho Kim, Oh-Seok Kwon, Hea-Young Cho (Source: Biologicals)
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
