A Discussion of Relevant and Meaningful Extraction Solvents for Extractables Testing of Implanted Medical Devices [0.03%]
植入式医疗器械提取物测试的相关及有意义的溶剂选择探讨
Dennis Jenke
Dennis Jenke
During their clinical use, medical devices contact, directly or indirectly, tissue of the person (patient) whose medical condition is being treated or monitored by the device. During contact, substances present in or on the medical device c...
Challenges for Visual Inspection and Particle Control in Cell Therapy Products [0.03%]
细胞治疗产品视觉检查和微粒控制的挑战
Roman Mathaes,Antonio Burazer,Satish K Singh et al.
Roman Mathaes et al.
Cell therapy products represent a transformative class of advanced medicinal products with unique manufacturing and quality control challenges. Unlike conventional parenteral products, cell therapies consist of living cells-typically delive...
Opportunities for improvement in managing pre-PPQ biologic product knowledge [0.03%]
关于完善生物制品上市前药品质量管理的思考与建议
Beth Fulton,Theo Zacharatos,Igor Gorsky et al.
Beth Fulton et al.
Knowledge management (KM) is vital for supporting product quality throughout a biologic drug product's lifecycle. This paper presents suggestions for management of pre-PPQ (Process Performance Qualification) knowledge management for biologi...
Vaccines and Public Health? [0.03%]
疫苗与公共卫生？
Shanker Gupta
Shanker Gupta
STRATEGY FOR VALIDATION OF NEW MYCOPLASMA NUCLEIC ACID DETECTION CLOSED SYSTEM AND IT USE IN ROUTINE BIOPHARMACEUTICAL MANUFCTURING [0.03%]
新一代支原体核酸封闭检测系统的验证策略及其在生物药生产中的应用
Caroline Kassim Houssenaly,Samad Amini-Bavil-Olayee,Carlos Salas Chung et al.
Caroline Kassim Houssenaly et al.
Mollicutes class (e.g. mycoplasma species) are notorious bacterial contaminants in eukaryotic cell cultures, known for being particularly difficult to detect and eliminate. Their presence can negatively impact the health of cultured cells, ...
Establishment of Limit of In Vitro Cell Age (LIVCA) for Biologics Manufacturing Process [0.03%]
生物制品生产过程中的体外细胞代次限值(LIVCA)的建立
Barbara Tevelev,Sharyn Farnsworth,Sarah Kaminsky-Pontell et al.
Barbara Tevelev et al.
This white paper explores current practices and industry experiences for establishing the Limit of In Vitro Cell Age (LIVCA) in biologics manufacturing. As per the International Council for Harmonization of Technical Requirements of Pharmac...
A Guide to Navigating Quality Control Requirements for Alternative and Rapid Microbial Methods in Sterility and Mycoplasma Testing Across the Asia Pacific Region [0.03%]
亚太地区无菌和支原体检测中替代及快速微生物方法质量控制要求指南
Juliana Gutierrez
Juliana Gutierrez
While alternative and rapid microbiological methods (ARMM) have gained broader acceptance in Europe and the United States, where guidance on their validation and implementation has been made available by the European Pharmacopoeia and Unite...
The Emerging Role of Regulatory Intelligence in Biotechnology: An Integrated Literature Review of Strategic Compliance and Innovation Framework [0.03%]
法规情报在生物技术中的新兴作用：战略合规与创新框架的综合文献回顾
Mara Girgis,Immanuel Jason Victor,Leonardo Tavormina et al.
Mara Girgis et al.
Regulatory intelligence (RI) is an emerging and increasingly fundamental function within regulatory affairs, particularly in the biotechnology sector. Defined by its focus on the systematic collection, analysis, and dissemination of regulat...
Roadmap to Implementation of a Rapid "Lab in a Pouch" NAT Method for Mycoplasma Testing [0.03%]
猫支原体快速检测试纸条的实施路线图
Philip Breugelmans,Karen de Roy,Orm Nieuwenhuizen et al.
Philip Breugelmans et al.
Mycoplasma testing is a mandatory assay for all cell-derived products as part of the microbial control strategy. The compendial methods include an indicator cell culture method and a culture assay. Because the culture assay takes 28 days, t...
Assessment of the microbiological quality of a preservative-free multidose system following a mixed culture microbial immersion challenge [0.03%]
评估混合菌群微生物浸入挑战后无防腐剂的多剂量系统微生物质量测定
Ian D Perry,Lutz Kroehne,Ioannis Koutsamanis et al.
Ian D Perry et al.
Current guidance on the microbiological qualification testing of preservative-free multidose ophthalmic systems is limited and lacking in detail with respect to methodology. This study describes the testing performed to assess the potential...