Newsletter | June 30, 2026

06.30.26 -- Mastering Biotech's Insourcing/Outsourcing Trade-Offs

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Cell Bank Manufacturing

Your master cell bank (MCB) is critical to therapeutic product development, in addition to supporting clinical development, manufacturing, and commercial supply of biologics. Put your bank in the hands of the experts and get it right the first time.

FOCUS ON OUTSOURCING

Mastering Biotech's Insourcing/Outsourcing Trade-Offs

Here's a case for the biotech hybrid model, one that relies on a crack team of internal core talent complemented by broad reliance on external vendors.

Flexibility Or Scale? Navigating The Single Use Vs. Stainless Steel Debate

Gain insight into how to choose between single‑use and stainless‑steel bioreactors, outlining key advantages, limitations, and long‑term considerations essential for successful biologics scale‑up.

Mobilizing Science And Partnership To Develop A Gene Therapy In 14 Months

Hear how one family, driven by urgency, partnered with AAV experts to develop a treatment for their daughter’s ultra-rare neurodegenerative disorder, NEDAMSS, in just 14 months.

Antibody-Based Drug Discovery At The Speed Of Light

Review this end-to-end workflow, including First-to-Human antibody development strategies, the use of the PentaMice® platform for targeted immunization, and the precision of single B cell screening.

Redefining CAR-T Speed And Strength: A Conversation

Delve into how an autologous CAR-T platform is addressing challenges in cell therapy manufacturing. A three-day process shortens cycles, improves T-cell potency and durability, and reduces costs.

Discussing Qualities Of A CDMO Redefining Innovation

Ensuring precision in fill/finish for large-volume devices is critical for performance. Discover the essential traits that redefine innovation and support patient-centric manufacturing solutions.

Building On Pittsburgh's Legacy To Industrialize Advanced Therapies

Pittsburgh's industrial roots and growing biotech hub unite to scale advanced therapies through new purpose‑built biomanufacturing, automation, and workforce development.

3 Steps To Guide Your Product To Annex 1 Compliance

To align with Annex 1 expectations, sponsors should focus on three key steps: understanding the guidelines, selecting the right partners, and futureproofing their manufacturing strategies.

Accelerate And De-Risk Bioconjugate Drug Development

With a growing interest in developing new and improved bioconjugate drugs, explore an “innovation through collaboration” approach that can facilitate access to next-generation conjugation technologies.

Unlocking Durable Allogeneic Cell Therapy

Advances in genome engineering and immune evasion are enabling scalable, durable allogeneic cell therapies, overcoming rejection challenges and expanding potential treatments across diverse diseases.

OUTSOURCING SOLUTIONS

Scalable Solutions For High Potent OSD Manufacturing - Recipharm

A Purpose‑Built Sterile Manufacturing Model - medac CDMO

Advancing Biologic Breakthroughs With Proven Expertise - Samsung Biologics

Capabilities Update May 2026: HPAPI And API Development - Ardena

Laboratory Services - Alcami

An Efficient Site-Specific Conjugation Technology - Abzena

Step Inside One Of America's Leading Protein Biologics CDMO Sites - AGC Biologics

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