Newsletter | December 9, 2025

12.09.25 -- The Future Of Biotech Outsourcing: Essential Skills For Program Managers

FOCUS ON OUTSOURCING

The Future of Biotech Outsourcing: Essential Skills for Program Managers

The next generation of program managers who liaise with contract manufacturers needs an expanded skillset to thrive.

From Platform To Patient: Streamlining Gene Therapy Development

Explore how platform processes advance gene therapies, the impact of strong partnerships on patient access, and the future shaped by these collaborations.

What To Expect From Your First CMO Remote Audit

Choosing the right manufacturing partner means going beyond just technical specs. Viewing the facility layouts and conditions is critical. Now is the time to familiarize yourself with remote auditing.

Getting To The Heart Of CDMO Tech Transfer Excellence

Discover five key factors that drive a seamless and efficient technology transfer, highlighting how a culture of technical expertise, customer focus, and operational flexibility is crucial to success in the CDMO industry.

The Stage-Gate Model: A Proven Approach To Streamline Biomanufacturing

Learn how a Stage-Gate approach to technology transfer and biomanufacturing can help to mitigate risk while shortening cycle times throughout the project lifecycle.

CDNPs Enable Versatile, Rapid, And Robust T Cell Expansion

Adopt next-generation, physiologic T cell activation strategies to enable faster, more consistent, and scalable CAR-T manufacturing that improves expansion, persistence, and patient access.

A Blueprint For Breakthroughs: Accelerating Rare Disease Therapies

To manufacture your rare disease therapy cost effectively, partner with an experienced CDMO from the outset. The right partner will offer development, manufacturing, quality, and regulatory expertise.

Analytical Strategies To Address Common Development Challenges

Discover analytical strategies designed to address challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs, and diverse post-translational modifications.

Custom Designed Linker-Payload Synthesis And Bioconjugation

Achieve ADC development with an integrated approach to linker-payload design and synthesis. Learn how custom synthesis and a bioconjugation strategy accelerate candidate selection and GMP manufacturing.

Achieving Rapid, High-Titer Expression For Next-Generation Biologics

This advanced cell line development technology overcomes production challenges related to the expression and scalability of complex biologics.

Development Strategies For Adenovirus-Based Gene Therapies

Scaling up viral vector production can be challenging, and ensuring consistent titers and activity requires careful optimization and technical expertise.

OUTSOURCING SOLUTIONS

Capacity Update January 2025: Fill/Finish - Lonza

Capacity Update April 2025: Fill/Finish - Simtra BioPharma Solutions

Capacity Update October 2025: Fill/Finish - Pfizer CentreOne

Organoid-Based Drug Screening Services - Samsung Biologics

Integrated ADC Offering: From Concept To Commercialization - Lonza

Sterile Drug Product - Curia

Two Sites, One Standard of Excellence - Jubilant HollisterStier

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