Newsletter | February 26, 2025

02.26.25 -- FDA Finalizes Guidance On The Advanced Manufacturing Technologies Designation Program

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FOCUS ON REGULATORY & COMPLIANCE

FDA Finalizes Guidance on Advanced Manufacturing Technologies Program

By Kim Benton, Dark Horse Consulting

The FDA released final guidance on the Advanced Manufacturing Technologies Designation Program at the end of December. This article shares a summary, analysis, and how it compares to the 2023 draft.

Bridging The Gap: Breaking APAC Into The US FDA Market

Article | By Jonathan Helfgott and Mathew Thomas, Ph.D., Biorasi

For APAC companies, it's important to identify the differences in care standards, formulate strategies for compliance, and develop solutions to bridge the regulatory gap and realize FDA approval.

5 Signs You've Outgrown Your Quality Management System (QMS)

Article | MasterControl, Inc.

An outdated QMS limits growth. Explore how upgrading to an advanced, configurable system like MasterControl can ensure scalability, automation and innovation. 

Perspectives On Performance, Scalability, And Regulatory Compliance

White Paper | Sartorius

Here, we discuss the challenges and solutions for cell and gene therapies, focusing on performance, scalability, and regulatory compliance to accelerate commercialization and improve patient access.

The Critical Role Of Training In Cleanroom Cleaning And Disinfection

Article | Contec, Inc.

Learn why proper training is vital in cleanroom cleaning and disinfection and how to develop and maintain a successful training initiative.

Utilize Modular Cleanrooms To Reduce Your Risk Of A Form 483 Violation

Article | By Trista Hager, AES Clean Technology, Inc.

Maintaining a cleanroom facility that remains safe for your workers – and where the therapeutics they produce remain safe for patients – can ease your compliance concerns.

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Join Cell & Gene Live for an exclusive look at cutting-edge manufacturing technologies revolutionizing cell therapy production. Our expert panel will explore organoids, 3D cultures, automation, and scalable solutions to streamline processes and enhance efficiency. Gain insights into the latest innovations driving the future of cell therapy. Registration is free thanks to the support of CPC and MaxCyte.

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