Newsletter | February 12, 2025

02.12.25 -- Industry Leaders On Analytical Method Development

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FOCUS ON REGULATORY & COMPLIANCE

Industry Leaders On Analytical Method Development

By Tyler Menichiello, contributing editor

Experts from Bristol Myers Squibb and Moffitt Cancer Center discuss best practices for analytical method development, as well as how to manage the successful transfer of these methods.

What Does The New Annex 1 Mean For The Aseptic Fill/Finish Industry?

Article | AST

The revised Annex 1 focuses on harmonizing regulations across the pharmaceutical manufacturing industry, prompting the pharmaceutical industry to strategize to achieve the best compliance method.

The Key To Avoiding FDA Recalls In Life Sciences

Article | MasterControl, Inc.

Explore the need for digital quality management systems to ensure compliance as life science companies face rising FDA recalls.

Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ

Article | Cencora

The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations.

Elevating Quality Beyond Compliance

Article | By Mike Jovanis, Veeva

See how one company was able to connect its quality processes, improve collaboration across business functions, and address the needs of its digitally-aware workforce.

CMC And Regulatory Considerations For CRISPR Therapies

Article | Synthego Corporation

This article explores the details of Chemistry, Manufacturing, and Controls and Critical Quality Attributes, which play an important role in gene editing.

EU GMP Annex 1: Impact On Cleaning And Disinfection

Article | By Karen Rossington, Contec, Inc.

Explore the most recent rewrite of the EU Annex 1 document as well as the contamination control strategy outlined within.

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REGULATORY & COMPLIANCE SOLUTIONS

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Quality Management System (QMS) For Drug Manufacturing - MasterControl, Inc.

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Orthogonal Method For Testing RCAAV - Bio-Rad Laboratories, Inc.

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