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April 2025 — 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.

EDITOR'S DESK

From BPI West: Key Challenges And Benefits Of Continuous Manufacturing
Continuous manufacturing was a hot topic of conversation at this year's BPI West. AstraZeneca's Ken Lee, Ph.D., weighs in during an exclusive interview with Bioprocess Online.

From BPI West: An Upstream Scientist's Advice On Target Glycosylation

Bioprocess Online spoke to an upstream scientist at Bristol Myers Squibb during this year's BPI West. Here's what he had to say.

2025 Cell Therapy Outlook From BPI West

Bioprocess Online and Cell & Gene spoke with Takeda’s Amy Shaw at BPI West to discuss the industry and her key takeaways from the conference.

Using AI And ML To Gain Insight Into Optimal Glycoforms

Bioprocess Online asked Nathan Lewis, Ph.D., to briefly explain the research he presented at BPI West 2025.

Impressions And Takeaways From BPI West 2025

Editor Tyler Menichiello reviews the most compelling topics and sessions from this year's BioProcess International U.S. West.

GUEST COLUMNISTS

Is Early Automation The Key To Scalable Cell Therapy Manufacturing?
Picking which phase to introduce automation has serious implications, and the calculation is unique for every product. Here are some important considerations.
Hard Lessons In Parenteral Automatic Visual Inspection
Complex problems can have simple solutions. That's what a team at AstraZeneca found when they set out to reduce false rejection rates in vials containing mAbs.
The EU Biotech Act Has Been Delayed — Here's What That Means
First due at the end of 2025, the act has been delayed until late 2026, which suggests key issues that many say hobble innovation will go unaddressed for longer.
From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025
The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.
Addressing Human "Error" In Pharma Manufacturing
Why is it that managers at pharma manufacturing sites continue to be frustrated by what could be labeled as “avoidable” human errors, and what can companies do about it? Let's investigate.
Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis
Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.
EMA Issues Draft Guideline On Quality Aspects Of mRNA Vaccines
The EMA's new draft guideline applies to mRNA vaccines for infectious diseases, providing guidance on manufacturing, characterization, specifications, and more. The deadline for public comments is Sept. 30, 2025.
EMA Issues Draft Reflection Paper On Accelerating Biosimilar Approval
In April, the European Medicines Agency issued a draft of a new guidance document titled Reflection paper on a tailored clinical approach in biosimilar development. The public consultation runs until Sept. 30, 2025.

BIOPROCESSING WHITE PAPERS

Incremental Adoption Of A Modular Operations Platform
Discover the potential of a modular operations platform that scales the benefits of digitalization and aids organizations in implementing a unified data strategy to realize the full potential of smart manufacturing.

Physiologix Serum Replacement Performance On T Cells
9/16/2024

A serum replacement for promoting T cell growth and functionality in cell therapy development shows comparable or superior performance to traditional human serum supplements.
Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility
10/16/2024

The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.
Benefits Of PCR-Based mRNA Manufacturing Processes
5/17/2024

Learn about a proprietary polymerase chain reaction (PCR) solution that was developed to overcome the challenges associated with pDNA that applies the high accuracy of PCR to mRNA manufacturing.
Performance Of HEKima™ Adherent HEK Cell Medium
9/16/2024

Explore the performance of a serum-free medium designed for HEK-293 cells, comparing its efficacy to traditional media for protein expression and cell proliferation.
Solid State Hydrogen Deuterium Exchange To Study Antibody Drug Conjugate Stability
10/16/2024

Discover how this solid-state HDX-MS is being used to revolutionize the prediction of stability for IgG-based Antibody Drug Conjugates and enhance ADC development processes.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

BIOPROCESS ONLINE CONTENT COLLECTIONS

This collection of articles digs into the industry’s growing focus on knowledge management as an indispensable facet of biomanufacturing and pharmaceutical development, exploring how it plays into risk management, quality, vendor relationships, and supply chain resilience.