Search results for "manufacturing"
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Downstream Processing for Cell-Based Therapies
…linical development, significant focus has been directed toward the development of scalable, robust manufacturing processes. Much of the research and development activity in the sector has addressed …
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Use of Multivariate Data Analysis in Bioprocessing
Applications involving multivariate data analysis of these complex data sets to extract relevant information could be aimed at process monitoring in a manufacturing setting by detection of process fau…
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Quality by Design—Bridging the Gap between Concept and Implementation
The international pharmaceutical companies in particular have benefited from applying QbD principles to their manufacturing operations. These companies have seen increased production efficiencies and …
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Report from the 12th Plasma Product Biotechnology Forum
With increased knowledge that implemented control strategies, as well as the manufacturing processes, showing no risk of prion contamination, a number of vCJD-related donor deferrals could be removed.…
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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…
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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…
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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…
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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; …
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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…
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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…