Newsletter | September 30, 2025

09.30.25 -- Why FDA's Tough Talk On Foreign Inspections Is More Bark, Less Bite

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Gain insight into leading CDMOs’ available capacity, capabilities, and timelines for biologic API development at the Large Molecule Drug Substance session of the Outsourced Pharma Capacity Update (Oct. 7). This virtual event highlights cell line development, fermentation, purification, and scale-up strategies — critical for producing high-quality biologics. Engage through short, interactive presentations and connect with CDMOs ready to support your pipeline needs. Open to biopharma companies, consultants, and investors seeking development and manufacturing partners. Save your spot today!

FOCUS ON OUTSOURCING

Why FDA's Tough Talk On Foreign Inspections Is More Bark, Less Bite

FDA Commissioner Marty Makary has promised to end the so-called "double standard" of announced overseas inspections. Does the agency have the resources?

Providing Enhanced Manufacturing Data To Contracting Companies

The life sciences sector is projected to reach $220 billion by 2030. Examine the growth of CDMOs and CMOs, emphasizing the need for digitalization to meet client demands and regulatory standards.

Embracing Quality-By-Design For Enhanced Development Strategies

In the biopharmaceutical development world, Quality by Design cuts risk, streamlines processes, and speeds up regulatory approval.

Optimizing CDMO Tech Transfer

Pitfalls exist at every step when attempting to replicate a production process, whether a process is being scaled for commercialization, reproduced at the same scale at an additional site, or transferred to another CDMO. Learn the challenges associated with tech transfers and how to overcome them.

Reducing Risk For Commercial Manufacturing Of Cell And Gene Therapies

For any biotherapeutic in development today, a critical element in achieving commercialization is reducing manufacturing risk.

Path To IND: AAV Transient Transfection, Producer Cell Line Platforms

The streamlined AAV transient transfection platform de-risks your path to IND and reduces complexity and timeline for lengthy process and analytical development.

Site-Specific Conjugation For Next-Gen ADCs

Unlock the full potential of your ADCs with a site-specific conjugation platform that delivers unmatched stability, homogeneity, and therapeutic performance.

Optimizing Monoclonal Antibody Manufacturing For Commercial Success

Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

OUTSOURCING SOLUTIONS

Zero Time to Master: PharmaLok ZerO - Nordson MEDICAL

Drug Product Fill And Finish - Curia

mRNA/LNP Development And Manufacturing Services - Lonza

Allogeneic And Autologous Cell Therapy CDMO Services - FUJIFILM Biotechnologies

No Cells, No Limits To DNA Production: Inside Synthetic DNA - Aldevron

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