Search results for " review" in Articles / App Notes
Article
Using Software in Process Validation
Digital validation systems help to set a protocol that requires review, signoff, and signatures. The protocol is always checked and authenticated before the process can go into production. Software sy…
Article
Methods Accelerate Biosimilar Analysis
As the foundation in the development of biosimilars is the analytical strategy, this paper reviews effective analytical methodologies available to perform in-depth characterization of both innovator a…
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Free On-Demand Webinar: Smart Process Development of Chromatography Steps
Join Peter Hagwall as he reviews three smart process development tools that enable reduced timelines and improved process outcomes:
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In-silico process development and data-driven decisions…
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Tools and Processes for Mature and Emerging Therapies
Cytiva also announced a partnership with Rockwell Automation to use augmented reality technology; biopharma companies will be able to monitor production processes, review equipment setup, provide inst…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
By Feliza Mirasol
With the recent FDA approvals and commercialization of cell and gene therapies in the US market and a pipeline of cell and gene therapies progressing toward regulatory review, …
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Prepare for an FDA Bioburden Inspection
Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips.
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Acknowledgements
The authors thank Barbara Taron for critical review of the article and Tasha José for assistance with graphics.
References
1. R. Duke and C. H. Taron, BioPharm Int. 28 (12…
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Ensuring Viral Safety of Viral Vaccines and Vectors
Braxton, American Pharmaceutical Review(2017).
30. B. Sanders et al., “Inactivated Viral Vaccine,” in Vaccine Analysis: Strategies, Principles and Control, B. Nunnally, V. Turula, and R. Sitrin,…
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Understanding Validation and Technical Transfer, Part 2
…luation of cleaning and maintenance procedures to ensure adequate frequency and effectiveness, and a review to determine whether any operational issues or employee training programs need to be adjust…
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Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
Specific topics will be the review of health challenges in Asia and future approaches to address them, creative technology solutions, facility and regulatory aspects, as well as vaccines and plasma de…