Newsletter | April 7, 2026

04.07.26 -- STREAM Edition: Regulatory Flexibility In CGT: Key Shifts And Implications With Monika Swietlicka

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On Demand Webinar - Avoiding Scale-Up Surprises: Applying AI and Rapid Prototyping to Media and Process Development

As biologics grow complex and timelines tighten, early development decisions around media, process, and scalability can create manufacturability challenges. In this webinar, Thermo Fisher Scientific experts explore how AI insights, data modeling, analytical testing, and rapid prototyping help teams evaluate choices earlier, reduce risk and prepare programs for cGMP scale-up and manufacturing readiness. Click here to learn more.

A Concept-To-Commercial Gene Therapy CDMO

Video | Andelyn Biosciences

This 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.

Maximize The Value Of Your AAV Using Small Volume AAV Testing

Webinar | MilliporeSigma

Learn about an approach to method development, where more than one AAV critical quality attribute can be measured within a single small-volume analytical run.

Breaking Down Shipping

Video | Cell & Gene

Listen to experts talk about whether temperature monitoring devices are really necessary when using a shipper that has been tested and validated to hold a specific temperature range for a specified period.

Stakeholder-Aligned Design For An Intuitive Manufacturing Process

Video | Invetech

Achieve intuitive and successful automated cell therapy manufacturing by aligning stakeholder needs with a human-centered design and rigorous, real-world process validation.

Regulatory Flexibility In CGT: Key Shifts And Implications With Monika Swietlicka

Video | Cell & Gene

On episode 125 of Cell & Gene: The Podcast, Host Erin Harris talks to Halloran Consulting Group's Monika Swietlicka to discuss how the FDA is increasing flexibility in CGT development without lowering evidentiary standards, emphasizing a risk-based, holistic approach.

Why Manufacturing And Quality Are Critical To Meeting FDA Expectations

Webinar | Cencora

CMC failures are a top reason for BLA rejections in cell and gene therapy. Discover proactive strategies to spot subtle quality gaps and ensure your manufacturing aligns with strict FDA expectations.

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Webinar: Advancing in-line PAT Solutions for Real-Time Batch Analysis

This PHC webinar explores how continuous metabolic insight strengthens feeding strategies, improves process understanding, and enables early detection of culture stress to reduce batch risk and improve yield. Learn how next-generation in-line PAT solutions deliver real-time glucose and lactate monitoring using electrochemical sensors. Discover how continuous data supports Quality by Design, reduces variability, and enables more predictive, efficient bioprocess operations. Click here to learn more.

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