Validation and implementation of Planova™ BioEX virus filters in the manufacture of a new liquid intravenous immunoglobulin in China
Publication date: March 2018Source: Biologicals, Volume 52Author(s): Shan Ma, Guang Li Pang, Yu Juan Shao, Tomoko Hongo-Hirasaki, Meng Xian Shang, Marcus Inouye, Chang Yong Jian, Meng Zhao Zhu, Hu Hu Yang, Jian Feng Gao, Zhi Ying Xi, Dian Wei SongAbstractThere is a continuous need to improve the viral safety of plasma products, and we here report the development and optimization of a manufacturing-scale virus removal nanofiltration step for intravenous immunoglobulin (IVIG) using the recently introduced Planova™ BioEX filter. IVIG throughput was examined for various operating parameters: transmembrane pressure, temperatu...
Source: Biologicals - July 5, 2018 Category: Biology Source Type: research
Distinct effect of fetal bovine serum versus follicular fluid on multipotentiality of human granulosa cells in in vitro condition
This study aimed to develop an appropriate medium for preservation of multipotentiality in human granulosa cells. To compare the possible effect of different media supplemented with follicular fluid or fetal bovine serum, granulosa cells were cultured in vitro over a period of 14 days. Stemness feature and any alteration in the cell phenotype were monitored using colony count assay and flow cytometry analysis by monitoring the expression of Oct3/4 and GATA-4 factors. Transcript expression level of Sox-2, Klf-4, and Nanog were investigated using quantitative real-time PCR analysis. Cells were cultured in the medium suppleme...
Source: Biologicals - July 5, 2018 Category: Biology Source Type: research
Comparison of reverse-transcriptase qPCR and droplet digital PCR for the quantification of dengue virus nucleic acid
Publication date: March 2018Source: Biologicals, Volume 52Author(s): Eric Abachin, Samantha Convers, Stephanie Falque, Raphaël Esson, Laurent Mallet, Nolwenn NougaredeAbstractPolymerase chain reaction (PCR) is an important molecular biology technique for in vitro amplification of nucleic acids. Reverse transcriptase quantitative PCR (RT-qPCR) and more recently reverse transcriptase digital droplet PCR (RT-ddPCR) have been developed for the quantification of nucleic acids. We developed an RT-ddPCR assay for the quantification of attenuated dengue virus serotype 2 nucleic acid and compared it with a routine RT-qPCR assay. W...
Source: Biologicals - July 5, 2018 Category: Biology Source Type: research
Directly injected native bone-marrow stem cells cannot incorporate into acetaminophen-induced liver injury
Publication date: March 2018Source: Biologicals, Volume 52Author(s): Azadeh Babaei, Azam Katoonizadeh, Azam Ranjbar, Mahmood Naderi, Naser AhmadbeigiAbstractThe paucity of liver donation highlights the use of cell-based strategies for end-stage liver failure. We recently showed that bone marrow-derived aggregates (BMDAs) can completely restore the hematopoietic system in gamma-irradiated mice. These aggregates are stem and progenitor cells in the bone marrow (BM), composed of both hematopoietic and non-hematopoietic lineages. Furthermore, reports showed that resident BM cells migrate to the liver and integrate themselves i...
Source: Biologicals - July 5, 2018 Category: Biology Source Type: research
Mass spectrometry analysis reveals differences in the host cell protein species found in pseudotyped lentiviral vectors
Publication date: March 2018Source: Biologicals, Volume 52Author(s): Sabine Johnson, Jun X. Wheeler, Robin Thorpe, Mary Collins, Yasuhiro Takeuchi, Yuan ZhaoAbstractLentiviral vectors (LVs) have been successfully used in clinical trials showing long term therapeutic benefits. Studying the role of cellular proteins in lentivirus HIV-1 life cycle can help understand virus assembly and budding, leading to improvement of LV production for gene therapy. Lentiviral vectors were purified using size exclusion chromatography (SEC). The cellular protein composition of LVs produced by two different methods was compared: the transient...
Source: Biologicals - July 5, 2018 Category: Biology Source Type: research
Humoral and cellular immune response in mice induced by the classical swine fever virus E2 protein fused to the porcine CD154 antigen
In this study, humoral and cellular immune response elicited in inbred BALB/c mice by immunization with a recombinant classical swine fever virus (CSFV) E2 protein fused to porcine CD154 antigen (E2CD154) was assessed. This model was used as a predictor of immune response in swine. Mice were immunized with E2CD154 emulsified in Montanide ISA50V2 or dissolved in saline on days 1 and 21. Another group received E2His antigen, without CD154, in the same adjuvant. Montanide ISA50V2 or saline served as negative controls for each experimental group. Animals immunized with 12.5 and 2.5 μg/dose of E2CD154 developed the highest tit...
Source: Biologicals - July 5, 2018 Category: Biology Source Type: research
Biochemical characterization, stability, and pathogen safety of a new fibrinogen concentrate (fibryga®)
In conclusion, the performed studies demonstrated that fibryga® meets the requirements for a state-of-the-art fibrinogen concentrate, such as a satisfactory activity profile combined with a favorable pathogen safety profile and stability. (Source: Biologicals)
Source: Biologicals - July 5, 2018 Category: Biology Source Type: research
Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies
This report summarises the discussions and outlines the conclusions and recommendations agreed on by the workshop participants. (Source: Biologicals)
Source: Biologicals - July 5, 2018 Category: Biology Source Type: research
WHO informal consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 27–28 April 2017
The objective of the meeting was to review the draft of WHO guidelines and the comments received from the public consultation. The guidelines were recognized by the participants as a tool for regulatory convergence and harmonization. Regulation of changes to approved biotherapeutic products is a key in ensuring that products of consistent quality, safety and efficacy are distributed after they receive authorization or licensure. Participants agreed that the guidelines would contribute to assuring the continued quality, safety and efficacy throughout the life-cycle of biotherapeutics as well as continuity in supply and acce...
Source: Biologicals - July 5, 2018 Category: Biology Source Type: research
Aims and Scope/Editorial Board/Publishing Details
Publication date: March 2018Source: Biologicals, Volume 52Author(s): (Source: Biologicals)
Source: Biologicals - July 5, 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 5, 2018 Category: Biology Source Type: research
Drug survival of biologic therapies for the treatment of psoriasis: Results of Slovenian national registry
Publication date: Available online 26 April 2018Source: BiologicalsAuthor(s): Tomaz Lunder, Pij Marko, Natasa Koser Kolar, Boris Kralj, Nada Kecelj LeskovecAbstractThe study was designed as observational retrospective analysis of the data from Slovenian Registry of patients with moderate and severe psoriasis treated with adalimumab, etanercept, infliximab or ustekinumab from 2005 to 2015. The survival rates of biologics were compared using survival analysis, and predictors of discontinuation were evaluated using a Cox regression model. All biologics have been prescribed as a first line therapy for moderate or severe psoria...
Source: Biologicals - July 5, 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 5, 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 5, 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 5, 2018 Category: Biology Source Type: research
