Newsletter | December 16, 2025

12.16.25 -- Why Your MVP And Its Evolution Matters To Manufacturing

SPONSOR

The 2026 ISPE Facilities of the Future Conference, 2-3 February, in San Diego, California, will explore regulatory compliance, workforce development, how digital tools are transforming manufacturing facilities, sustainability and facility design, and how companies are building flexibility and resilience into future facility plans. Technical tracks include: Compliance and Quality; Digital Transformation, AI Integration, and the Future Workforce; Facility Design; Innovative Manufacturing and Sustainability. LEARN MORE.

FOCUS ON OUTSOURCING

Why Your MVP And Its Evolution Matters To Manufacturing

Minimum viable product is one of the most important inputs to developing a manufacturing process. It defines essentials that matter to the people who make the product.

Reducing Environmental Impact At All Stages Of The Medicine Journey

Explore how utilizing technologies like AI and digital twinning can inform decision-making at the R&D stage and how to optimize the delivery of the final drug product to patients with greener logistics.

Solving Bispecific Antibody Heavy-Light Chain Mispairing

Dive into case studies that demonstrate the performance of a bispecific pairing technology that drives correct heavy-light chain pairing rates in IgG-like bispecifics to >95%.

Essential Insights Into Linker Chemistry For ADCs

The linker is key to an ADC's success, influencing stability and targeted drug release. Learn about the evolution of linker chemistry, from cleavable mechanisms to site-specific conjugation.

Successful Completion Of The Project NaDiNa

Conducted alongside Palacky University's Faculty of Medicine and supported by the Technology Agency of the Czech Republic, this project focused on translating research into a viable medicinal product.

Improving Safety And Efficacy With Charged Variant Characterization

Discover how a CDMO with extensive experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic.

Reaching BLA Success: Fast-Track Approach To Process Characterization

Learn how knowledge of microbial processes and process characterization understanding can be used to design targeted BLA programs while managing risks.

Using Digital Tools In Process Development

Technology can transform the entire biopharma production process chain. Using integrated process models, machine learning, and genetic algorithms has made production faster and more efficient.

8 Reasons To Choose A Trusted GxP Partner

Explore eight essential reasons why leading BioPharma companies trust this GxP partner to support compliance and operational success in regulated environments.

Driving Robust Tech Transfer In Biologics: CFD Simulation

Computational Fluid Dynamics simulation is essential for robust biologics tech transfer. See how this predictive tool optimizes critical scale-up processes, reducing risk and expediting time to market.

Manufacturing Of CAR-T Cells: Automation And Defined Culture Conditions

The process associated with the manufacture of CAR-T cell therapies presents challenges that immensely impact patient accessibility to these treatments. Reducing manufacturing complexity is key.

OUTSOURCING SOLUTIONS

Capacity Update October 2025: Fill/Finish - Argonaut Manufacturing Services

Capacity Update April 2025: Fill/Finish - Resilience US, Inc.

Capacity Update October 2025: Large Molecule - Cytovance Biologics

Capacity Update October 2025: Analytical Services - Labcorp Biopharmaceutical CMC Services

Contract GMP Biologics Analytical Services - Catalent

Leveraging Advanced Technology And Proven Expertise - Catalent

Services Designed To Take You From Molecule To Market - Cytiva

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