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September 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.

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EDITOR'S DESK

On The Ground At BPI: Jacqualyn Schulman, Ph.D., On Accelerating Clonal CLD
An interview with Jacqualyn Schulman, Ph.D., a principal scientist at Bristol Myers Squibb (BMS), on her presentation at BPI 2026, “Fast-Tracking CHO Cell Line Development Using Integrated Engineering Strategies.”

AstraZeneca's Focus On Predictive Control, Semi-Autonomous Processing

This article captures key takeaways from a BioProcess International keynote by Preeya Boppana, director of MSAT process analytics and laboratories at AstraZeneca, titled “Transforming Biologics Manufacturing: Leveraging Predictive Analytics and Advanced Process Control for Next-Generation Operations.”

Prioritizing Quality Over Everything

Regulatory compliance and cGMP manufacturing expert Tatyana Matveeva, Ph.D., explains the role and importance of a quality unit in an organization, as well as what happens when it’s compromised.

Evaluating The Levers Driving Productivity In Bioprocessing

Experts discuss where productivity gains can be achieved and how development teams should seek to improve process performance in this recap of the Bioprocess Online Live event "The Levers And Tradeoffs That Drive Process Productivity."

Overcoming Recovery Challenges In AAV Production

Siren Biotechnology's SVP of vector development, Nathalie Clément, Ph.D., explains the challenge of purifying AAV capsids and the ways developers are optimizing vector recovery.

GUEST COLUMNISTS

Is Your Supply Chain Ready For The End Of Class VI?
Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.
When Lyophilization Fails At Scale, First Scrutinize Your Formulation
When lyophilizing a challenging biologic drug product, use an integrated approach optimizing formulation and process parameters together.
The 5 Shifts That Could Remake Lyophilization By 2040
Purdue University-based LyoHUB charts a risk-based course to modernizing freeze-drying technology for better performance and advanced modalities.
Complete Response Letters For CGTs Share This Common Theme
One expert’s analysis found CMC-related concerns in about 75% of complete response letters. He outlines a path to stronger CMC readiness for cell and gene therapies.
Your 7 Decisions To Make Before MES Configuration
Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
DEA Reveals Hidden Costs Of Analytical Validation Guidelines
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.

BIOPROCESSING WHITE PAPERS

Building Late-Stage Efficiency Into Biologics Development
Building late-stage efficiency early in biologics development prevents scale-up delays. Flexible platforms and risk-based validation streamline technology transfer and lower production costs.

ICH E6(R3) In Effect: Transforming Quality Management For Cell And Gene Therapy Trials
1/29/2026
Onshoring Advantage: 7 Forces Reshaping Global Biologics Manufacturing
10/27/2025

Policy, trade, and security pressures are fundamentally reshaping global biologics manufacturing. Forward-looking companies are onshoring critical programs to mitigate risks to supply chains, IP, and regulatory timelines.
Overcoming Challenges To High-Concentration Formulation Development
3/25/2025

Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.
Super Short Activated CAR-T Process
1/17/2025

Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.
Cell Line Development For Bispecific Antibodies
8/18/2025

See how the recently described cell line development paradigm shift, enabled by the Leap-In transposon platform, can extend to the development of bispecific monoclonal antibody-producing cell substrates.

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BIOPROCESSING APP NOTES & CASE STUDIES

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EDITORIAL COLLECTIONS KNOWLEDGE CENTER

Editorial Collections are subscriber-only, curated resources that combine expert interviews, feature articles, and industry analysis to help readers better understand emerging trends, operational challenges, regulatory developments, and best practices shaping the biopharma industry.

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