Newsletter | December 23, 2025

12.23.25 -- Strained Manufacturing, Complexity Stymie In Vivo Progress

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The 2026 ISPE Facilities of the Future Conference will provide actionable insights and real-world case study examples addressing key industry challenges and opportunities, from best practices in facility design, digital transformation, and emerging technologies, to sustainability initiatives, workforce development, and compliance-related considerations. Gather innovative ideas on how to align your business priorities with forward-looking trends and prepare for the future. LEARN MORE.

FOCUS ON OUTSOURCING

Strained Manufacturing, Complexity Stymie In Vivo Progress

 Explicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational risk.

AI Implementation To Enhance Quality

Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.

Vial Fogging: Practical Considerations For Vial Selection

Vial fogging is a common phenomenon in lyophilized biologic drug products. Examine two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.

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.

Manufacturing Strategies And Facility Design For Patient-Centric Delivery

Review how to select the optimal manufacturing strategy and technologies for efficient and scalable production of therapeutic proteins. De-risk the supply chain, accelerate time to market, and reduce costs.

Improve The Performance Of Your Small And Large Molecule Medicines

Explore the latest in nanotechnology advancements including recent clinical data, formulation applications, and API optimization to NanoImprove formulations.

Inclusion Bodies: Mother Nature's Help Or Hindrance?

Explore strategies to improve the performance of IB processes as well as the pros and cons of soluble and insoluble processes: isolating, solubilizing, and properly refolding.

Technology Transfer: A Seamlessly Integrated Approach

From the digital infrastructure needed to enable a collaborative approach, to the quality systems and analytical methods, effective tech transfer relies on the careful consideration of a variety of factors.

Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs

Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.

Managing Supply For Complex Biotherapeutics

Antibody-drug conjugates' manufacturing supply chain contains five different technologies with specific asset needs: monoclonal antibody, cytotoxic payload, linker, bioconjugation, and fill & finish.

OUTSOURCING SOLUTIONS

Capacity Update October 2025: Fill/Finish - medac CDMO

Capacity Update April 2025: Fill/Finish - Catalent

Contract Services To Optimize Continuous Nanoparticle Processing - DIANT Pharma

Deliver Potent Cell Therapies Faster And More Reliably - BlueWhale Bio

Sterile Fill/Finish Services - Bora Pharmaceuticals

Tools For Developing Successful Biologics: XS Pichia Expression System - Lonza

Ergonomic Solutions For Complex Biologics Delivery - BD Medical - Pharmaceutical Systems

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