Donor biological materials and excipients of animal origin are important components in the production of biomedical cell products (BMCPs). Their quality ensures the stability, safety, effectiveness and purity of the final product. This review discusses quality requirements for biological excipients intended for the production of biomedical cell products, in terms of the necessary information that should be included in the BMCP registration dossier during state registration and is subject to expert assessment during quality control. Considering that there is currently no production of biomedical cell products in the Russian Federation, the authors considered international approaches to ensuring the safety of donor material and excipients for the manufacturing of human cell- and tissue-based products (BMCP analogues).
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7580781 | PMC |
| http://dx.doi.org/10.1039/c9md00529c | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
405 nm violet-blue light inactivates hepatitis C cell culture virus (HCVcc) in ex vivo human platelet concentrates and plasma.
Sci Rep
December 2024
Division of Blood Components and Devices, Center for Biologics Evaluation and Research, FDA, Silver Spring, MD, 20993, USA.
Added safety measures coupled with the development and use of pathogen reduction technologies (PRT) significantly reduces the risk of transfusion-transmitted infections (TTIs) from blood products. Current approved PRTs utilize chemical and/or UV-light based inactivation methods. While the effectiveness of these PRTs in reducing pathogens are well documented, these can cause tolerable yet unintended consequences on the quality and efficacy of the transfusion products.
View Article and Find Full Text PDFHybrids of copper cysteamine nanosheets and silver nanocluster ensure superior bactericidal capability via enhanced photodynamic effect.
Sci Rep
December 2024
School of Biomedical Sciences, Suzhou Chien-shiung Institute of Technology, Suzhou, 215411, People's Republic of China.
Over the past decades, bacterial infections resulting from the misuse of antibiotics have garnered significant attention. Among the alternative antibacterial strategies, photodynamic therapy (PDT) has emerged as a promising non-antibiotic approach. However, persistent bacterial biofilms, particularly those composed of gram-negative bacteria with their protective outer membranes, have exhibited remarkable resilience to PDT.
View Article and Find Full Text PDFSex differences in cardiac energetics in the rat ventricular muscle.
Sci Rep
December 2024
Auckland Bioengineering Institute, The University of Auckland, Auckland, New Zealand.
Cardiac sex-difference functional studies have centred on measurements of twitch force and Ca dynamics. The energy expenditures from these two cellular processes: activation (Ca handling) and contraction (cross-bridge cycling), have not been assessed, and compared, between sexes. Whole-heart studies measuring oxygen consumption do not directly measure the energy expenditure of these activation-contraction processes.
View Article and Find Full Text PDFHDL-C is inversely associated with the incidence of osteoarthritis among the USA: evidence from the NHANES program of 1999-2020.
Sci Rep
December 2024
Department of Orthopedic Surgery, National Clinical Research Center for Geriatric Disorders, Hunan Engineering Research Center of Biomedical Metal and Ceramic Implants, Xiangya Hospital, Central South University, Changsha, 410008, China.
Osteoarthritis (OA) has been the most common arthritis affecting public health all over the world. Previous experimental research reported that increased low-density lipoprotein cholesterol, along with decreased high-density lipoprotein cholesterol may be associated with increased ectopic bone formation and possible knee OA, while clinical evidence is absent. This study aimed to investigate the association between blood high-density lipoprotein cholesterol (HDL-C) and OA.
View Article and Find Full Text PDFUltrasound-responsive nanoparticles for nitric oxide release to inhibit the growth of breast cancer.
Cancer Cell Int
December 2024
Department of Ultrasound, Chongqing General Hospital, Chongqing University, Chongqing, 401147, China.
Gas therapy represents a promising strategy for cancer treatment, with nitric oxide (NO) therapy showing particular potential in tumor therapy. However, ensuring sufficient production of NO remains a significant challenge. Leveraging ultrasound-responsive nanoparticles to promote the release of NO is an emerging way to solve this challenge.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!