Newsletter | November 11, 2025

11.11.25 -- Supporting The Next Generation Of ADCs

SPONSOR

With more than 65 years of sterile injectable manufacturing experience, Simtra BioPharma Solutions offers world-class GMP sterile fill and finish services, deep scientific and technical expertise, and a uniquely collaborative approach to support our customers’ strategic objectives. As two industry-leading CDMOs in the ADC field, MilliporeSigma and Simtra have forged a Strategic Alliance for Drug Substance and Drug Product ADC Manufacturing with the shared goal to delivering your drug development program to market more efficiently.

FOCUS ON OUTSOURCING

Supporting The Next Generation Of ADCs

Experts discuss innovation in antibody-drug conjugate (ADC) technology and how these impact CMC strategy. This summary captures key takeaways from the Bioprocess Online Live event "Evolving CMC Strategies To Enable Next-Gen ADCs."

Friendshoring: A Strategic Shift In Pharma Supply Chains

To safeguard the consistent delivery of essential therapies to patients around the world, biopharmaceutical companies, alongside their CDMO partners, are rethinking traditional supply models.

Building A Path To Approval With Effective Regulatory Support

When partnering with CDMOs, success depends heavily on collaboration with a partner that combines deep technical expertise with a proven record of regulatory excellence and operational reliability.

Manufacturing Strategies To Industrialize Autologous Therapies

Discover how a systematic approach to autologous cell therapy manufacturing can reduce costs, improve reliability, and accelerate access to life-changing treatments.

Microbial Tech Transfer: Tips To Consider When Selecting A CDMO

Choose a flexible and experienced CDMO to ensure seamless scalability, diverse process capabilities, and expert analytical support for your microbial protein production.

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.

Current And Emerging Technologies To Optimize mRNA Manufacturing

Understand the benefits of using mRNA for vaccines and therapeutics, and learn how to address technical, intellectual property, and cost considerations when considering commercial production.

Early Development To Clinic – De-Risking A Bioconjugate's Journey

The journey of a novel bioconjugate into clinic is complex and uncertain. Explore the particular challenges when moving a bioconjugate candidate from early development into clinic.

RTU Components: Why You Need Them

Ready-to-use (RTU) components can simplify processing requirements for aseptic fill and finish by reducing the need for equipment, utilities, and product space.

What The Proposal Process Reveals About A CDMO Partner

The way a CDMO responds to a request for proposal provides significant insight into how the CDMO will approach a long-term collaboration.

Shaping The Future Of Biologics Manufacturing

CEO Kenneth Bilenberg discusses building a CDMO's success on trust, reliability, and true partnership. The path focuses on agility to support biologics growth and the reshoring of U.S. manufacturing.

Building A Biomanufacturing Ecosystem For Supply Agility Starts Early

Unprecedented capital investments of >$8bn expand capacity to improve patient access. Going beyond expansions, learn more about a holistic, globally harmonized operational ecosystem.

Optimizing Biotherapeutic Protein Expression With CHO Vector Technology

Review the development of a high-strength synthetic gene promoter that enhances titers and maintains exceptional product quality and expression stability to support more efficient biomanufacturing.

Mastering The Journey From Method Transfer To Successful Lot Release

A panel of experts share potential pitfalls and lessons learned from their many years of experience across a wide array of projects in the cell and gene therapy space.

Streamlining The Path To FIH

Explore how KBI Biopharma’s SUREtechnology Platform™, powered by Selexis®, accelerates the development of complex biologics from early stages to first-in-human (FIH) trials, focusing on both speed and quality.

SPONSOR

Join life sciences experts and global regulators this 9–10 December for the 2025 ISPE Pharma 4.0™ Conference in Barcelona, Spain, or virtually. This year's agenda spotlights how innovative enabling technologies including AI, machine learning, virtual and augmented reality, industrial internet of things, GxP cloud platforms, robotics, advanced modeling, and automation, are addressing key challenges like drug shortages and improving product availability. LEARN MORE

OUTSOURCING SOLUTIONS

Capacity Update October 2025: Fill/Finish - medac CDMO

Alachua Campus Tour Video - Resilience US, Inc.

European Center Of Excellence For Clinical Biologics - Catalent

Partnering With You From Preclinical Through Commercial Scale - Andelyn Biosciences

Advancing Vaccines From Preclinical To Commercial Supply - FUJIFILM Biotechnologies

Excellence In Every Injection. - Pfizer CentreOne

Evaluating Performance Factors Of Cryopreserved PBMCs - Lonza

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