Newsletter | September 3, 2025

09.03.25 -- Calculating The Right In-House/Outsource Mix For ADC Manufacturing

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Webinar: Streamlining Vaccine Purification: Techniques for Modern Modalities

Advances in vaccine development demand faster, more efficient processes. This Thermo Fisher Scientific webinar explores chromatography purification tools that accelerate downstream development for diverse vaccine modalities, including mRNA, viral vectors, recombinant proteins, and VLPs. Through case studies on HPV, Malaria, and COVID-19, attendees will learn how affinity and ion exchange resins enable high-purity, high-yield purification from lab to large-scale production. Click here to learn more.

FOCUS ON FILL-FINISH

Calculating The Right In-House/Outsource Mix For ADC Manufacturing

Antibody-drug conjugate innovators often question whether to outsource manufacturing activities or bring them in-house. Here are some key considerations.

De-Risking The Transition From Vial To Drug-Device Combination Product

When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.

Transitioning From Vial To Prefilled Syringe

Understand how formulation development for a prefilled syringe affects manufacturing, driving the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

Biofluorescent Particle Counters Are Gaining Momentum

The 2025 BioPhorum report highlights challenges and trends in drug filling operations and how they are advancing towards biofluorescent particle counters. Discover an approach that aligns with industry needs.

Enabling End-To-End Process Solutions For Bottles

Until recently, only isolated solutions for working filling, freezing/thawing and transporting sensitive drug materials were available. Learn how we've addressed this problem with end-to-end bottle solutions.

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Explore 20+ new CDMO presenters in quick 20-minute sessions during Outsourced Pharma’s October Partner Week. Sessions include Analytical Services, ADC, Large and Small Molecules, Cell and Gene Therapy, and Fill/Finish. Each session offers a quick, informative look at capabilities to help you find the best-fit partner. Registration, on-demand access, and interactive Q&A are all free.

FOCUS ON DOWNSTREAM MANUFACTURING

HCP Detection And Quantitation

Learn the ins and outs of host cell proteins (HCPs), HCP ELISA, and HCP contaminants, as well as how to improve your recombinant protein production.

A Strategic Assessment Tool For Modernizing Buffer Preparation

Modern biomanufacturing requires a strategic, multi-criteria approach to buffer management. Discover how a hybrid model can optimize your operations and address fluctuating demands.

The Science of Selection: Choosing The Right Hollow Fiber Filter

Learn how hollow fiber tangential flow filtration enhances downstream bioprocessing with efficient ultrafiltration and diafiltration, reduced fouling, and scalable performance.

Optimizing TFF And SPTFF For High-Concentration mAb Formulations

Discover the role of formulation buffer composition in stabilizing monoclonal antibodies during tangential flow filtration, a process involving ultrafiltration and diafiltration under high pressure and shear forces.

Simplify Your Bioprocess Development With Custom Buffers

Tailor your bioprocess for optimal cell growth, gene expression, and therapeutic production with custom buffers to ensure precise control over pH, ion concentrations, and nutrient availability.

How To Increase Productivity With Rapid CIP

This protein capture device demonstration showcases a cycling protocol that uses fast loading and non-loading residence times as well as a rapid CIP out to 100 cycles.

DOWNSTREAM MANUFACTURING SOLUTIONS

Purify Specialized mAbs - Ecolab, Purolite Resins

Single-Use Film Engineered For Superior Strength And Leak Resistance - MilliporeSigma

Purification Strategies, Solutions For Biotherapeutic Molecules - Bio-Rad Laboratories, Inc.

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