Newsletter | February 10, 2026

02.10.26 -- STREAM Edition: 2026 Regulatory Roadmap: Get Set Up For Success

Advanced Contamination Control: Automation, Assays, And Process Efficiency

Webinar | Thermo Fisher Scientific Bioproduction

Learn how automated closed systems and larger bioprocess containers contribute to maintaining product integrity and how rapid analytical assays can offer reliable and accurate contamination detection.

 

The Road To Approval: Viral Clearance Strategies For Non-Enveloped Viral Vectors

Webinar | MilliporeSigma

Know the differences between designing a viral clearance study for non-enveloped viral vectors versus those for mAbs or recombinant proteins, and discover how to identify and remove viral contaminants.

A Concept-To-Commercial Gene Therapy CDMO

Video | Andelyn Biosciences

The Curator™ adherent platform has been used to manufacture more than 450 Phase 1 and 2 clinical batches, spanning over 17 years and covering a variety of serotypes and indications.

The Need For Improved Cryoprotectants: Upgrade Storage Solutions

Video | Cell & Gene

Cryoprotectants are added chemicals or media that protect cells during freezing and thawing — and until we can lyophilize cells, they’re our best bet at preserving cell therapies for storage.

2026 Regulatory Roadmap: Get Set Up For Success

Virtual Event | Cell & Gene

Wilson Bryan, M.D., former director of FDA’s Office of Tissues and Advanced Therapies (OTAT), and Daniela Drago, Ph.D., RAC, Partner at NDA Partners, translate regulatory expectations into practical strategies for CGT sponsors as they design trials, plan filings, and position programs for global success.

Utilizing Flow Cytometry For Humoral Immunogenicity Testing: Cell & Gene Therapy

Webinar | Eurofins

Explore strategies to overcome immunogenicity challenges by harnessing flow cytometry to enhance ADA and NAb assay development, strengthen validation, and ensure regulatory readiness.