Newsletter | September 8, 2025

09.08.25 -- Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured

SPONSOR

Webinar: From Diagnosis to Dose in 14 Months: Accelerating Gene Therapy

Discover the inspiring story of how the Krueger family, with the help of Andelyn Biosciences and leading gene therapy experts, developed a treatment for their daughter’s ultra-rare condition in just 14 months—defying timelines. This webinar reveals the power of patient-led advocacy, cutting-edge AAV manufacturing, and bold partnerships, offering a replicable roadmap for rare disease communities seeking faster cures. Click here to learn more.

FOCUS ON OUTSOURCING

Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured

An element of the 2025 BioPlan Associates annual report and survey took Chief Editor Louis Garguilo by surprise. The report intimates that biopharmaceutical manufacturing faces a fractured CDMO market. Despite solid data to back that assertion up, Garguilo presents a very different view, one based on what many readers have expressed.

Synergies Between Vaccine Expertise On Developing, Manufacturing C&G Products

Understanding these synergies and their impact on efficiency, safety, and cost-effectiveness is essential for stakeholders navigating the complexities of CGT development and production.

Viral Vector Manufacturing: A Case For Adherent Cell Culture

Review the importance of alternative approaches to viral vector production and the benefits of intensified adherent cell culture for improving efficiency, reducing costs, and accelerating development.

Guiding Principles For Process Development And IND Readiness

Observe how a milestone-driven risk management strategy streamlines cell therapy development, reduces uncertainty, and aligns early decisions with long-term commercialization and regulatory success.

CRISPR Portfolio, Modalities Accelerate Candidate Identification

See how this cutting-edge, AI-driven genome editing technology can accelerate the development of precise, clinically viable therapies for genetic diseases.

Next-Generation AAV Helper Plasmid Boosts AAV9 Productivity

Enhancing AAV production efficiency is critical for expanding gene therapy applications — this optimized helper construct significantly boosts yield and potency.

cGMP-Ready Clonal HEK293 Cell Line For AAV, Lenti-, And Adenoviral Vectors

See how this advanced SKPT-HEK293 4G9 was able to provide a robust, CGMP-ready solution for efficient viral vector production, supporting a range of AAV serotypes and CAR-T Lenti-viral vectors for scalable manufacturing.

A Deep Dive Into Expression Approaches For Biotherapeutics

Whether you’re at the discovery stage or thinking about commercial production, gain useful insights on expression formats from transient transfection, through stable pools to stable clones.

Smoothing The Path To Successful mRNA Manufacturing

Producing mRNA therapeutics requires navigating complex manufacturing challenges. A strategic partnership with an integrated CMO streamlines manufacturing processes and reduces costs.

Gene And Cell Therapy: Planning For Manufacturing Success Early

As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.

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.

OUTSOURCING SOLUTIONS

AAV Gene Therapy: Charting The Course Through Clinical Challenges - MilliporeSigma

Accelerate Path To Clinic With CMC Consultation Services - Excellos

Testing Solutions For Viral Vector-Based Products - SGS

Overcoming Development And Manufacturing Challenges - AGC Biologics

UpTempoâ„  AAV Platform Process - Catalent

EVENTS

Advancing the Future of Cell & Gene Therapy

This 11-12 November, Cell 2025 unites 1,000+ leading experts across the CGT value chain to solve key challenges, from scalable bioprocessing and regulatory hurdles to accelerating development timelines.

 

Gain practical strategies across cell culture, therapy development, and CGT manufacturing, and hear from world-renowned leaders Bobby Gaspar (CEO, Orchard Therapeutics), Christof Von Kalle, (Director & BIH Chair, Research Clinic Luxemburg), and Dame Molly Stevens (University of Oxford). Register Now

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