Search results for " regulators"
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Taking a “Development-by-Design” Approach to Cell Therapies
Regulations evolve
Cell therapy is still a new area for regulators, and, as Preti says, some guidelines are clear and others aren’t. “Development by design is needed throughout the process, but th…
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Global Expansion Shapes Drug Oversight
FDA will be represented by a European-based team, with the aim of moving beyond information-sharing to “strengthen mutual reliance” on trusted regulators outside the US.
Challenges in India and…
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Sterilization Trends for Single-Use Consumables
On the regulatory side, another important trend revolves around growing expectations from regulators for biopharmaceutical manufacturers to better understand the control of irradiation processes rathe…
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Traceability in Western Blot Imaging: Considerations for GxP
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Densitometry analysis of gels is a key part of quality control in the pharmaceutical drug release process. In regulated environments, electronic record-keeping can improve both tra…
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The Importance of Partnering for Bioanalytical Studies
The Importance of Partnering for Bioanalytical Studies
Yakobchuk Olena/Stock.Adobe.com
Bioanalytical studies are an important aspect of biologic drug development that may necessitate…
Article
Biopharma Seeks Balance
…understanding, share knowledge to develop cost-effective processes, and earn the trust of investors, regulators, and the public.
References
1. J. Woodcock, “FDA Proposes Process Modernization…
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Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
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Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems.
By Jerold M. Martin
Single-use technologies (SUT) have made significant inroads in …
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Lessons Learned Accelerate Vaccine Development
… IDT at -60 °C, the governments of the affected countries, the World Health Organization (WHO), and regulators,” notes Kesselmans. Janssen has proven that the product can be stored at customer sites …
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Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …