Search results for "manufacturing" in Articles / App Notes
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
Over the years, cell-culture processes have evolved to achieve optimum production yield and quality for both clinical development and commercial manufacturing.
Cell-culture evolution
Current c…
Article
Understanding Validation and Technical Transfer, Part 3
Acceptance criteria are established based on data obtained from preclinical and clinical studies as well as from demonstration lots used to show manufacturing consistency and from stability studies. I…
Article
CoAs Help Secure the Supply Chain
European Commission, EudraLex Volume 4, Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Part I, Basic Requirements for Medicinal Products, Chapter 4: Documentation (EC, 2…
Article
Managing Residual Impurities During Downstream Processing
There is, however, no set of standard assays for the determination of contaminants such as HCPs during manufacturing because each biopharmaceutical process is unique and results in unique impurities; …
Article
Managing Risk in Raw Material Sourcing
The goal is a safe, robust formulation that will meet bioequivalence and stability requirements, but also enable validatable manufacturing, explained Chris Moreton, consultant with FinnBrit Consulting…
Article
Defining Risk Assessment of Aseptic Processes
Can you offer some advice on how I should proceed in putting together this assessment?
A: Aseptic processing of IV injectable drugs is certainly one of the riskiest manufacturing operations. Your m…
Article
Real Time Continuous Microbiological Monitoring
By Claudio Denoya
Nonviable particulate and viable microbiological surveillance are used to evaluate the design and control of a current good manufacturing practice (cGMP)-manufacturing environmen…
Article
A Q&A with Eric Langer: CMOs Embrace New Technology
In our 13th Annual Report of Biomanufacturing, of the 21 areas of innovation tested, we found CMOs more interested in: chromatography, single-use probes and sensors, disposable chromatography, instrum…
Article
Downstream Processing Continues to Worry CMOs
Langer
Downstream processing continues to be a significant pain point for contract manufacturing organizations (CMOs), and downstream-fueled bottlenecks don’t appear to show any signs of abating, …
Article
Vaccine Development Faces Urgency and Challenges
Additional resources would help the US Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) further the development and manufacturing of new Zi…