Newsletter | September 2, 2025

09.02.25 -- Our Supplier Failed? Heck No, We Failed Our Supplier!

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The PDA Pharmaceutical Microbiology Conference 2025 marks two decades of advancing microbiological science and practice. This milestone event brings together the global microbiology community, including experts from industry, academia, and regulatory agencies, to explore the evolving landscape of pharmaceutical microbiology. This year's theme, Microbial Resilience: Today's Response, Tomorrow's Plan, reflects our focus on navigating present-day challenges while building robust strategies for the future.

INDUSTRY INSIGHTS

Accelerating Gene Therapy Development For NEDAMSS

Discover how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis.

Keys To A Successful cGMP Manufacturing Operation Delivering CGTs

Uncover the secrets behind successes in commercializing and producing commercial cell and gene therapies, including establishing standards of every day, manufacturing operational excellence.

The Advantages Of Off-The-Shelf GMP iPSCs With A DMF

Learn how off-the-shelf, GMP-grade iPSC lines with a Drug Master File (DMF) can accelerate cell therapy development, streamline regulatory approval, and reduce time and cost to clinic.

FEATURED EDITORIAL

Our Supplier Failed? Heck No, We Failed Our Supplier!

“We would be in meetings, and someone would disparage a certain CDMO. But one of our leaders would almost always have the opinion that we could make the relationship work. ‘No one is perfect, including us,’ he said.” Outsourcing is an attitude, explains Dan Marasco. Here's the attitude he says you should bring to your external partnerships.

Case Studies: Is AI Making Biologics And CGT Outsourcing Smarter?

This continues our discussion of AI and CDMOs, focusing on biologics and cell and gene therapy (CGT) relationships.

INDUSTRY INSIGHTS CONTINUED

Mastering The Journey From Initial Method Transfer To Successful Lot Release

A panel of experts share potential pitfalls and lessons learned from their many years of experience across a wide array of projects in the cell and gene therapy space.

Insights Into GMP Manufacturing Of RNA-LNP Drug Products

Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, and strategic collaborations.

Optimization Of rAAV Production Using An In-House Suspension HEK293 Cell Line

Boost rAAV yields and quality while reducing costs with our proprietary HEK293 cell line and scalable, optimized manufacturing platform for gene therapy.

Taking A Look At AAV Production Using HEK293 In A Perfusion Process

A unique, scalable, and cost-effective approach to generating AAV viral vectors leverages a high-performing cell line, optimized reagents, and purpose-built technology.

Optimizing Cell Therapy Analytics Through DoE Methodologies

Design of Experiment (DoE) methods streamline the development of robust, phase-appropriate potency and functional assays, ensuring consistent, efficient, and regulatory-aligned testing.

Securing INmune Bio's Trial Materials In A Crisis

Discover how a sudden biostorage shutdown put INmune Bio’s trial at risk, revealing the critical importance of logistics and rapid coordination in protecting advanced therapy programs.

SOLUTIONS

Microbial Services

With decades of hands-on experience in microbial fermentation and a commitment to scientific precision, we’ve built a trusted foundation that continues to drive successful outcomes for our partners.

Oligonucleotide Discovery And Development

Comprehensive R&D support advances therapeutic oligonucleotides, with tailored formulation development services across multiple modalities and delivery platforms.

A Leading CDMO In AAV Manufacturing

Amid challenging times for therapeutic developers, learn about an exciting initiative that will accelerate data acquisition for investor funding.

Bioengineering Solutions Using A Fully Integrated Ecosystem

Find solutions to meet your gene, protein, antibody, or cell line needs using two gene synthesis platforms that enable the design of constructs optimized for maximal expression/yield in your system.

Accelerate Path To Clinic With CMC Consultation Services

Learn more about a limited number of complimentary 60-minute CMC consultations designed to provide early-stage developers with strategic guidance before they engage a CDMO partner.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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