Enhanced product understanding acknowledges the technology advancements of the last 25 years and substantially more complex drug modalities.
- Retrofitting Facilities For Modern Bioprocessing And Pharma Production
- MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs
- Intensifying Downstream Processing With Magnetic Separation
- Trends In FDA FY 2024 Inspection-Based Warning Letters
- AI Performance Management In Biologic And Drug Development
- February 2025 — CDMO Opportunities And Threats Report
- Challenges In Manufacturing TIL For Clinical Trials
EDITOR'S DESK
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Easing Autologous Cell Collection, Automating Manufacturing
To circumvent the challenges of leukapheresis, CellProthera developed a novel method for collecting therapeutic stem cells from whole blood. CSO Ibon Garitaonandia, Ph.D., discusses the company's mission to streamline manufacturing.
Experts from Bristol Myers Squibb and Moffitt Cancer Center discuss best practices for analytical method development, as well as how to manage the successful transfer of these methods.
In this closing segment from the executive roundtable discussion, our panelists express their confidence in the industry's mission and maintain a positive outlook for the years ahead.
In this segment of the executive roundtable discussion, our panelists weigh in on how to prepare for what may be a challenging financial climate in 2025.
In this segment of the executive roundtable discussion, our panelists discuss the changing political landscape and its potential effects from a regulatory and economic point of view.
GUEST COLUMNISTS
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Retrofitting Facilities For Modern Bioprocessing And Pharma Production
The U.K. National Health Service is developing a former warehouse into a multi-modal aseptic manufacturing hub. The project's production head talks pros, cons, and strategy.
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MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs
The U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025.
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Intensifying Downstream Processing With Magnetic Separation
A technique used widely in other industries like steel production and wastewater treatment has emerged as rising star within bioprocessing over the last 10 to 15 years.
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Trends In FDA FY 2024 Inspection-Based Warning Letters
Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. You may be surprised at some of them.
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AI Performance Management In Biologic And Drug Development
Life cycle maintenance is essential in AI-driven drug development. Regulators recommend continuous updates to AI models to monitor and adjust for data pattern changes.
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February 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.
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Challenges In Manufacturing TIL For Clinical Trials
Tumor-infiltrating lymphocyte cell therapy shows promise for treating solid tumors, but its complex manufacturing profile brings a unique set of issues. Here are some things to watch out for.
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Combination Products: U.S. Vs. EU Requirements And A Harmonized Strategy To Prepare CTD Module 3
In the U.S. and the EU, there are differences in the terminology used for combination products, as well as in the format and location of the information in the dossiers. This article also proposes a harmonized approach for CTD Module 3.
BIOPROCESSING WHITE PAPERS
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Small Volume ATMP Cryo-Freezing Strategies
Discover best practices for cryopreserving small-volume ATMPs, focusing on sterility, viability, and efficiency with advanced containers and packaging.
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Suspension Culture Improves iPSC Expansion And Pluripotency Phenotype12/19/2024
Learn about the advantages of 3D suspension culture for iPSC expansion, including enhanced pluripotency and genetic stability. Discover how this technique yields high-quality iPSCs for regenerative cell therapies.
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Assessing Reliability, Confidence, And Batch Variation In PPQ Runs6/29/2023
Examine the procedures and benefits of two statistical methodologies and how new technologies are requiring a risk-based approach to calculate the necessary number of PPQ runs.
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Labware Washing Techniques And The Sinner's Circle9/27/2024
Explore labware cleaning techniques, comparing manual and automated processes, and how balancing the four factors of the Sinner’s Circle ensures effective, repeatable laboratory outcomes.
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Development And Regulation Of Veterinary Monoclonals2/8/2024
Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.
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Quality By Design (QbD) For Biologics From A CDMO Perspective2/18/2025
Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.
BIOPROCESSING APP NOTES & CASE STUDIES
- Get Reproducible Purification Scale-Up Results Faster
- Engineering CHO K1 Cells With Three Orthogonal Transposase Systems
- Maximizing Scale-Up Efficiency Of A mAb Upstream Process
- Global BioPharma Saves Reporting Time On ADA Studies
- Reliable Proliferation And Differentiation Of Desired T Cell Subpopulations With CellGenix® Recombinant Human Interleukin-2 (IL-2)
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.
More Content CollectionsFEATURED PRODUCTS AND SERVICES
ON-DEMAND WEBINARS
- Managing Risks In Injectable Drug Delivery
- Human Factors Testing: Engaging End-Users In Med Device Development
- Bioprocess Optimization: Leveraging Functional DOE With Time-Based Insights
- Next-Generation Digital Technology For Pharma R&D And Manufacturing
- Monitoring Compressed Gases For Microbial And Particle Contamination
INDUSTRY NEWS
NEWSLETTER ARCHIVE
- 03.14.25 -- STREAM Edition: A New Approach To Biotech Financing
- 03.14.25 -- 10 Ways To Streamline Early-Stage Drug Product CMC
- 03.13.25 -- Promote Successful Cell Growth And Viability From Start-Up To Scale-Up
- 03.13.25 -- Challenges And Opportunities Of Outsourcing Biopharma Development
- 03.12.25 -- Automating Digital Twins Implementation In Downstream Bioprocessing