Newsletter | October 15, 2026

10.15.26 -- The CDMO's Perspective: Audience Q&A With Thermo Fisher Scientific

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Webinar: Scaling for Commercial Success: Accelerating Late-Stage Biologics Through Platform-Based Manufacturing

As biologics programs move toward commercialization, manufacturing strategy becomes critical. This webinar with Avid Bioservices explores how platform-based approaches can reduce risk, accelerate timelines, and improve consistency across technology transfer and scale-up. Discover practical considerations for capacity planning, supply chain readiness, and manufacturing infrastructure to help support commercial growth while maintaining quality, supply continuity, and regulatory compliance. Click here to learn more.

FOCUS ON OUTSOURCING

The CDMO's Perspective: Audience Q&A With Thermo Fisher Scientific

During this final segment from the Bioprocess Online Live event, “Making The Jump To GMP: Material Decisions For Clinical Manufacturing,” a representative and SME from the event sponsor enters the conversation. Mike Brewer, director and global principal consultant of regulatory and bioproduction at Thermo Fisher Scientific, joins the panel for a special Q&A session with the audience, discussing the challenges he’s witnessed sponsor companies face in the transition to clinical manufacturing.

 

 

Accelerating An Innovative High Potency Oncology Therapy To Market

See how disciplined containment, proactive risk management, and collaboration accelerate oncology programs under tight timelines while protecting quality, safety, and global launch readiness.

 

Beyond Compliance: A Strategic Approach To Annex 1

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.

 

Faster Paths To Biosimilar Equivalence: Turning Guidance Into An Advantage

Evolving biosimilar guidance creates opportunities to reduce comparative clinical requirements through strong analytical evidence, risk-based justification, structure-function knowledge, and more.

 

The Challenges Of Moving A Bioconjugate From Clinic To Market

Working with a partner that provides a one-stop shop for bioconjugate development and manufacturing helps prevent missteps that threaten the delivery of life-saving drugs to patients who need them.

 

Expanding Subcutaneous Design Brick By Brick

Biologics are growing more complex. But what if the syringe itself could unlock new possibilities? Discover the technology “bricks” quietly reshaping subcutaneous drug delivery.

 

Antibodies Against Antibodies? Anti-Idiotype mAb Discovery

Explore the potential of targeting LILRB2/LILRB4 in cancer immunotherapy by delving into our findings on novel monoclonal antibodies that enhance anti-tumor immune responses.

 

Drug Development Plan Explained: DPP Templates And Examples

Only 6.7% of Phase 1 drugs reach approval. A well-structured Drug Development Plan (DDP) can meaningfully improve your odds — learn exactly how to build one.

 

Integrated Manufacturing To Mitigate CMC Risks, Simplify Commercial Supply

Leveraging cross-functional coordination between sites, harmonized tech transfers, one quality system, and synchronized team activities can streamline regulatory submissions.

OUTSOURCING SOLUTIONS

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Capabilities Update August 2026: Oral Solid Dose Formulation - Alcami

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Capabilities Update August 2026: CPHI Special Edition - Simtra BioPharma Solutions

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Advance Your Complex Large Molecule Program - Rentschler Biopharma

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Capabilities Update September 2026: ADC - LOTTE Biologics

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Integrated CDMO Services For Advancing Biologics - Syngene International Ltd.

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