Search results for " validation" in Articles / App Notes
Article
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…
Article
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 …
Article
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…
Article
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…
Article
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…
Article
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,…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
To be successful, however, the lead partner will need an understanding of biomanufacturing facility design, engineering, qualification, and validation, as well as the operational aspects of combining …
Article
Viral Clearance Challenges in Bioprocessing
Process representation
Another challenge for viral clearance validation is accurate process representation. “In order to perform high-quality viral clearance studies and avoid unreliable, inaccurat…