Newsletter | September 30, 2025

09.30.25 -- Lilly's Kinsale Facility Provides A Benchmark For Your CDMO Selection

SPONSOR

Discover the latest in analytical services for cell and gene therapies on Oct. 6 at the Analytical Services session of the Outsourced Pharma Capacity Update. This virtual event features concise presentations, live Q&As, and insights into assay development, method validation, and analytical platforms. Designed for biopharma professionals and investors, it connects you — from the convenience of your computer — with CDMOs that have the capabilities and available capacity to support your therapeutic pipeline. Save your spot today!

INDUSTRY INSIGHTS

Phase-Appropriate Approaches To Manufacturing And Testing

Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.

Gene Therapy In-Use And Device Compatibility Studies

Discover an essential aspect of development that ensures gene therapy products remain safe, stable, and effective throughout preparation and administration by simulating real-world clinical conditions.

Enhancing AAV Purification: Strategies For Improved Recovery, Quality

This study evaluates filter trains from four vendors, aiming to enhance titer recovery, HCP removal, DNA breakthrough, turbidity reduction, and throughput in gene therapy manufacturing.

FEATURED EDITORIAL

Lilly's Kinsale Facility Provides A Benchmark For Your CDMO Selection

Consider these two questions: How do we select a CDMO? How do we select a facility? The second of these should carry as much weight as the first, but unfortunately often does not. Chief Editor Louis Garguilo thinks that should change. He turns to Eli Lilly's ISPE Award Winning facility, and Lorraine O'Shea, Associate Vice President and Plant Manager at Lilly Kinsale, to make the case.

Manufacturing Interleukin-2 For In Vivo Use: Key Considerations

Interleukins help optimize therapeutic outcomes in cancer immunotherapy and regenerative medicine. Manufacturing success requires stringent control over production, formulation, and stability to ensure safety and efficacy.

INDUSTRY INSIGHTS CONTINUED

Leveraging Novel Analytical Approaches For Advanced Therapies

Review the advantages and limitations of transcriptional assays versus reporter gene assays and how the transcriptional assay compares to ddPCR and flow cytometry for analysis of CGTs.

ATMP Development In 2025: Promise, Pressure, And The Push To Scale

Drive the next wave of cell and gene therapy innovation by overcoming operational, funding, and regulatory challenges to deliver life-changing treatments to patients faster.

A Continuous Electroporation System For Viral Gene Therapy

Explore the development work involved for the individual technologies that make up an innovative and scalable, chemical-free continuous viral vector production platform.

Working With An End-To-End CDMO To De-Risk AAV Production

Consider how the following strategies can be used to optimize AAV manufacturing by reducing risk and balancing productivity, quality, and cost to meet the growing demands of gene therapy.

Deploying Technology For Rapid Clinical Material Delivery

Learn 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.

SOLUTIONS

Enabling Your Vision For The Future

Our team of experts can help you navigate the complex manufacturing and development lifecycle for cell and gene therapies from bench to bedside.

Capacity Update July 2025: Cell & Gene Therapy

With a robust track record of more than 7,500 GMP batches and proven platforms for multiple modalities, we pride ourselves on delivering speed, scalability, and reliability.

Analytics-Driven AAV Development And Manufacturing

Gain a comprehensive understanding of the biochemical composition of each vector batch while minimizing product consumption, ensuring efficiency and precision in analysis.

UpTempo AAV Platform Process

As the pipeline of viral vector-based therapies continues to reach later-stage studies, a standardized manufacturing process is necessary for CMC requirements from regulatory agencies.

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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