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June 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.

Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices
Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification

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EDITOR'S DESK

Lonza Bets On Biologics. What's It Mean For You?
It’s a large and universally recognizable CDMO, so this matters. Swiss-based powerhouse Lonza will increase its focus on biologics, and “advanced synthesis” including for antibody-drug conjugates (ADCs), cell and gene therapies (CGT), and mRNA therapeutics. Will other CDMOs follow suit? What's this say about the future of development outsourcing and our industry?

BIO2025 Recap: FDA Reducing Animal Testing, Governor Shapiro On Supporting Biopharma, Practical AI Use

Bioprocess Online chief editor Tyler Menichiello shares his three key takeaways from the 2025 BIO International Convention.

Analytics And Cross-Functional Communication: Keys To Purifying Complex Molecules

This summary features key takeaways from the Bioprocess Online Live event, "Challenges And Considerations For Purifying Multispecific Molecules."

How Modular Facility Design Can Accelerate GMP Facility Construction

Autolus Therapeutics' COO talks about the accelerated construction of the company's cell therapy manufacturing facility, The Nucleus.

A Facilities Expert Answers Audience Questions On Construction And Validation

Bioprocessing facility expert Herman Bozenhardt responds to some unanswered audience questions from a Pharmaceutical Online Live event on facility design and validation.

GUEST COLUMNISTS

Sorriso's Path To Oral Biologics Dosing Is Through The Gut
Following positive results from a Phase 1b trial, company leaders describe scaling their yeast expression and spray-drying processes as they prepare for Phase 2.
Why 'Which Is Best?' Is The Wrong Question In CGT Development
In cell therapy development, the instinct to seek a single “best” option is natural — but in reality, there’s rarely a universal winner.
Understanding FDA's New National Priority Voucher Pilot Program
The FDA's vouchers will be issued to companies addressing health issues in the U.S. and increasing domestic manufacturing, among other criteria.
The Latest Techniques And Technology For Differentiating Capsids
Since AAV gene therapy’s origins, scientists and regulators have sought optimized ways to measure empty/full capsids. This expert reviews pros and cons of modern methods.
AI-Assisted QMS: Bridging ISO/IEC 42001:2023 And ICH Q10 For Pharmaceutical Excellence
Integrating AI into quality management systems (QMS) can be a transformative opportunity to enhance quality assurance, improve compliance, and enable proactive risk management.
Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight
Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.
Ask The Pros — The Latest In Downstream HCP Mitigation
Two downstream biologics processing experts address some of the field's complex, nagging questions about mitigating host cell proteins.
How Is RIM Software Transforming Regulatory Compliance?
Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.

BIOPROCESSING WHITE PAPERS

5 Steps To Completing A Successful Root Cause Analysis
Discover how Root Cause Analysis transforms manufacturing by addressing underlying issues, improving quality, and preventing future failures, which empowers teams to move from reactive fixes to strategic solutions.

Innovation In Filtration
3/18/2025

Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars
2/9/2024

The presence of ADAs can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
Analytical Techniques For Characterization, Release, And Stability Testing
4/28/2025

Review the analytical considerations for subunit vaccines, vaccines that contain only the antigenic component(s) of a pathogen, and more specifically the assays needed.
Optimizing Reference Standards For Your Biopharmaceutical
1/29/2024

By addressing considerations for a comprehensive reference standard strategy, manufacturers can ensure the integrity of biopharmaceuticals, ultimately paving the way for better patient outcomes.
Advancing A LNP Formulation To Clinical And Commercial Manufacturing
3/25/2024

Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

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BIOPROCESSING APP NOTES & CASE STUDIES

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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.