Search results for " validation"
Article
Mapping a Route for Cell and Gene Therapy Process Development
These factors make process development and validation for cell and gene therapies a challenging and highly critical task.
Scaling differences
Depending on the application (i.e., autologous vs.…
Article
Putting Viral Clearance Capabilities to the Test
The manufacturing limits of parameters in these steps that might have an impact on the virus reduction should be challenged in the virus validation studies prior to Phase III, to show the robustness o…
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Aseptic Processing: Keeping it Safe
Just because validation of a sterile effluent typically occurs under the “worst-case scenario” tenet, it does not mean that facilities should operate with this frame of mind when ironing out their ase…
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Continued Process Verification for Biopharma Manufacturing
Guidance issued by FDA in 2011 (1) emphasized the importance of manufacturers undertaking CPV as an integral part of the process validation lifecycle. CPV will provide the manufacturer with assurance …
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Regulatory Challenges in the QbD Paradigm
…ent, and ICH Q10 Pharmaceutical Quality System as well as by the recently issued guidance on process validation from FDA (5, 7–9). The past five years have seen QbD gaining widespread adoption in the…
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Design and Qualification of Single-Use Systems
• Documentation should also be considered as part of product design, to include support data for performance claims, design and production validation data reports, operation guides, and other informat…
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Tackling Analytical Method Development for ADCs
Fortunately, both improvements in analytical technology and increased experience with ADCs are leading to improved strategies for analytical method development and validation.
Both small and large…
Article
Quality by design for biotechnology products—part 1
An alternative strategy for process-related impurities, such as DNA or host cell proteins, is to demonstrate multi-log removal by validation that is conducted in a fashion similar to the validation of…
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Eliminating Residual Impurities Starts with a Strategic Plan
Depletion of such molecules in the final process design should, however, be confirmed during process characterization and process validation.
Many regulations
There are several relevant…
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Managing Residual Impurities During Downstream Processing
…method development and qualification as fit for use, how to address dilution linearity during method validation, the use of HCP immunoassays for process development, characterization, and validation,…