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Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities

The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.

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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

Unlocking Value In Biopharma Operations: A C-Suite Call To Action
Operational readiness will separate the leaders from the laggards, whether you lead a pharma/biotech innovator, CDMO, or a combination of both.
Audit Trail Compliance And What To Look For In Mitigation Software
In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.
The New Clinical Packaging Paradigm: Differentiation And Decentralization
The rapid evolution toward flexible, decentralized clinical supply models is placing unprecedented strain on traditional clinical packaging organizations. Can traditional models adapt fast enough to stay viable?
Drug Facility Design For Live Biotherapeutic Products
Live biotherapeutic products use live microorganisms or yeast as active agents to prevent or treat diseases. For pharma manufacturers entering this emerging field, understanding the unique GMP requirements is critical.
What Did ICH Q14 Miss On Analytical Method Validation?
Revisions to ICH Q14 remedied some shortcomings, but the latest version still contains errors and ambiguities. Here is a detailed breakdown.
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
Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.
Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification
A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.

BIOPROCESSING WHITE PAPERS

Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility
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.

Utilizing MAPPs For An Enhanced Assessment Of Immunogenicity
1/4/2024

Explore how MAPPS demonstrates promise as a valuable tool for comprehensive immunogenicity assessment in therapeutic protein development, contributing to safer and more effective biologics.
Quantitation Of Monoclonal Antibodies In Serum
2/8/2024

Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.
De-risks Your Monoclonal Antibody Scale-Up Process
7/20/2023

Improve your mAb production by adopting a technology platform approach using a fluid handling system that can transition from development to your final production volume.
Navigating CMC Regulation For Plasmid DNA In Gene Therapy
5/28/2025

Explore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.
Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization
8/25/2023

There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.

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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.