Search results for " validation" in Articles / App Notes
Article
Technology Innovations Improve Process Chromatography Performance
Reducing the costs for cleaning and cleaning validation are also challenges that many big companies and contract manufacturing organizations (CMO)/contract development and manufacturing organizations …
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Good Manufacturing Practices: Challenges with Compliance
In addition, there is not a lot of guidance on how to handle mixtures of materials and what constitutes an appropriate method validation, especially for complex dosage forms which may contain other in…
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2019’s Top Bioprocessing Trends and What to Expect in 2020
QbD, Regulatory, and Validation Considerations
Viral clearance is a topic on the minds of many in the biopharma industry, and for good reason. Considering the manufacturing challenges experienced …
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Best Practices for Selecting a Top-Quality Cell Line
“[These] data, along with the right bioinformatics, can allow for direct assessment of the clonality of the biotherapeutic production cell line and provide traceability, validation, and origin of cell…
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Cell-Culture Advances Test Bioreactor Performance Models
The evolution of cell-culture technology is driving the need for improvements in modeling solutions.
By Cynthia A. Challener
Modeling and simulation are recognized to provide assistance i…
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Case Study: Virus Reduction of an Affinity Capture Step
Evaluating how much a process step contributes to viral clearance is an essential part of process validation. For this reason, there is an industry need to perform effective viral clearance studies. I…
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Ensuring Viral Safety of Viral Vaccines and Vectors
EMEA, Note for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses. CPMP/BWP/268/95, (London, revised 1996).…
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Transformative Medicines Challenge FDA and Manufacturers
FDA approved Spinraza with a number of post-approval study and quality assessment commitments, including programs to re-evaluate drug substance method validation data and acceptance criteria, to re-ex…
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Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Stückler not only showed how the approach could be used for deeper process understanding in early process development, but also the benefits of mechanistic models at the process characterization, vali…
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The New World of Biopharmaceutical Manufacturing
Advantages of single-use technology include greater flexibility, reduced resources for cleaning and cleaning validation, and faster turnaround between products and batches, resulting in reduced capita…