Newsletter | June 25, 2026

06.25.26 -- May 2026 — CDMO Opportunities And Threats Report

FOCUS ON OUTSOURCING

May 2026 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

The Difficulties Of Working With Multiple Siloed Partners

By working with a single supplier that can handle the entire manufacturing value chain, companies can reduce risk, improve flexibility, and accelerate their time to market.

Yeast Extracts: Improving Expression

Yeast extract improves E. coli protein production by over 50%, boosts desired protein attributes 4X, and offers a secure animal-free nutrient source.

Overcoming Challenges In Combination Product Manufacturing

Blending pharmaceuticals and medical devices into a single product offers immense potential for patient care, but manufacturing these combination products presents unique hurdles.

Bispecific T- Cell Engager (BiTE) Screening, Automated Pipeline

View automated, high‑throughput BiTE screening in mammalian cells, enabling rapid discovery of efficacious variants through precise genomic integration and scalable workflows.

Hunting An Unexpected mAb Variant With LC‑MS

A tailored LC–MS approach enables sensitive detection and tracking of monoclonal antibody variants, supporting deeper product characterization and better control of quality‑impacting changes.

Understanding Drug Substance And Product Manufacturing

Understanding drug substance vs. drug product responsibilities helps avoid regulatory issues, technical risks, and delays while improving planning, scalability, and GMP‑compliant execution.

Device Design For Usability And Risk Reduction

Growing use of large‑volume subcutaneous therapies is increasing demand for wearable injectors that reduce user error, simplify preparation, and enhance safety through human‑factors‑focused design.

From DNA To IND In As Little As 6 Months

Discover how an integrated, platform-driven CMC approach can accelerate your antibody program from DNA to IND in as little as six months while reducing risk and maintaining quality and regulatory alignment.

Regulatory Considerations For First-Time Drug Developers

Navigate the challenging path from concept to clinical reality by partnering with an experienced CDMO that can provide the regulatory, clinical, and CMC expertise you need.

Strategically Design Your Quality Control Toolkit To Better Mitigate Risk

If you’re hoping to improve your QC toolkit to better accommodate complex modalities like cell and gene therapies, it's time to build a program that accounts for risk and unique product characteristics.

Fast Path To Market: Going From GMP1 To PPQ In Just 12 Months

Learn how focused optimization and coordinated execution helped overcome technical uncertainty and enable faster progression to market readiness.

OUTSOURCING SOLUTIONS

End-To-End Custom Media And Buffer Solutions - Lonza

Providing Development And Supply Of Life-Changing Medicines - FUJIFILM Biotechnologies

Flexible Support To Advance Large‑Molecule Programs - Cytovance Biologics

Advancing Lyophilization Through Formulation, Process Development - Coriolis Pharma

USP General Chapter 382: Health Inspired, Quality Driven - SGS

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