Newsletter | March 9, 2026

03.09.26 -- Putting Pressure On CDMOs With Herman Bozenhardt

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Join Cell & Gene Live Chief Editor Erin Harris on March 19, at 11am Eastern for Materials Matter: Ensuring Quality of CGT Materials. In this live event, experts will explore evolving expectations around material selection, characterization, and sourcing; emerging guidance and standards from USP; how smarter analytics and vendor partnerships can reduce batch failures and CMC setbacks, and more. Register for free thanks to support from our sponsor MilliporeSigma.

FOCUS ON OUTSOURCING

Putting Pressure On CDMOs With Herman Bozenhardt

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Herman Bozenhardt, a consultant and industry veteran who has spent decades advancing the fields of biopharmaceutical manufacturing, engineering, and regulatory compliance.

Making A Meaningful Impact In AAV

Review the latest advancements in gene therapy production, focusing on how in-house plasmid manufacturing and commercialization strategies work together to reduce overall manufacturing costs.

Derisking And Accelerating Drug Development With Expertise

Minimize risk and improve manufacturability with specialized scientific guidance. Learn how custom development approaches stabilize complex drug programs to reach commercialization faster.

Ensuring Compliance For Virtual And Hybrid Pharmaceutical Companies

Proactive, risk-based oversight must be established to manage outsourced GXP activities. This requires a robust QMS and comprehensive quality agreements to safeguard product quality and data integrity.

Why Asia Should Be Your Next Trial Destination

Many U.S. oncology sponsors are expanding their late-phase trials into Asia to secure access to teeming patient pools, leverage efficient regulatory pathways, and save time and money in the clinic.

Viral Clearance Strategies For Monoclonal Antibodies And Proteins

Design robust viral clearance studies using risk-based strategies and optimized assays. This guide provides real-world case examples for maintaining safety in antibody and protein production.

Leveraging Technology For Rapid Clinical Material Delivery

Discover how one family's collaboration with a specialized CDMO enabled the rapid development of a life-saving gene therapy for their daughter diagnosed with an ultra-rare disease.

Optimization Of In Vitro Transcription For mRNA Production

Optimize your mRNA production with an advanced IVT process, enhancing scalability, purity, and expression activity for clinically relevant RNA therapeutics.

OUTSOURCING SOLUTIONS

Retrovirus Testing By Real Time PCR-Based F-PERT - IDT Biologika

Gene Editing Platform: One-Step Large Knock-In Technology - Applied StemCell

Genetic Medicines, From Idea To Impact - ElevateBio

Your CDMO Partner From CMC Development To Commercial Supply - Kincell Bio

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