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Do Patient Needs Define Biologic Product Specifications?

Enhanced product understanding acknowledges the technology advancements of the last 25 years and substantially more complex drug modalities.

EDITOR'S DESK

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.

Industry Leaders On Analytical Method Development

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.

Optimism For Biopharma In 2025

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.

How Biotechs Can Navigate Market Uncertainty In 2025

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.

Political Influences And Regulatory Implications For Biotech 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

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.
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.
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.
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.
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.
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.
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.
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

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.

Suspension Culture Improves iPSC Expansion And Pluripotency Phenotype
12/19/2024

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.
Assessing Reliability, Confidence, And Batch Variation In PPQ Runs
6/29/2023

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.
Labware Washing Techniques And The Sinner's Circle
9/27/2024

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.
Development And Regulation Of Veterinary Monoclonals
2/8/2024

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.
Quality By Design (QbD) For Biologics From A CDMO Perspective
2/18/2025

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.

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.