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Navigating Data Management Requirements For Sterile Manufacturing

Contamination control strategies are rooted in representative and trustworthy data, but companies still do a poor job at maximizing their use of data to optimize.

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EDITOR'S DESK

Experts' Advice On Facility Design And Construction
This is a review of the Pharmaceutical Online Live event “Facility Design And Validation Considerations For Drug Manufacturers," which featured industry experts Erich Bozenhardt and Herman Bozenhardt, as well as process architect Fred Grossfeld.

Tariffs Won't Stop Drug-Candidate Licensing From China Biotechs

According to Global Data, the total deal value of U.S. licensing of innovator drug candidates from Chinese biopharma companies has surged since 2020. This is an area way upstream of the current tariff focus on manufacturing. But how this R&D trend and those tariffs play out will impact your U.S.-based CDMOs.

From BPI West: A Roundtable Discussion On Continuous Manufacturing

Process Development experts share their thoughts on continuous manufacturing at this year's BPI West, touching on its benefits and present barriers to adoption.

From BPI West: Key Challenges And Benefits Of Continuous Manufacturing

Continuous manufacturing was a hot topic of conversation at this year's BPI West. AstraZeneca's Ken Lee, Ph.D., weighs in during an exclusive interview with Bioprocess Online.

From BPI West: An Upstream Scientist's Advice On Target Glycosylation

Bioprocess Online spoke to an upstream scientist at Bristol Myers Squibb during this year's BPI West. Here's what he had to say.

GUEST COLUMNISTS

Bracing For The Impact Of The Federal Workforce Reduction
The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.
Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements
This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.
Demystifying The Common Technical Document For Global Submissions
The CTD's Module 3 is notoriously complex and challenging. Here are strategies for an easier path toward CMC submission readiness.
May 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.
The Matryoshka Model: The New Face Of Contract Packaging In Pharma
Contract packaging organizations are the outer layer of the pharmaceutical Matryoshka (the iconic Russian nesting doll): the final form that contains within it a series of intricately crafted parts.
Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis
Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.
The Latest On CRISPR Deployment In TIL Therapy Development
Here’s a quick look at how CRISPR’s emerging as an enhancer to improve TIL pharmacokinetics, efficacy, and tolerability without disrupting production.
Clues To Mapping A Crisis-Ready Tech Transfer Playbook
One of the many people behind AstraZeneca's COVID-19 response describes lessons learned during the biggest global health emergency of the modern era.

BIOPROCESSING WHITE PAPERS

Preclinical Evaluation Of RSV Vaccines And Antivirals In BALB/c Mice
Accelerate your RSV therapeutic development with clinically relevant preclinical models and expert IND-enabling services that deliver the data needed to advance confidently toward clinical trials.

Cell Collection Basics — Fundamentals For The Transplant And CGT Industries
6/3/2025

Breakthroughs in CAR T-cell and stem cell therapies depend on mastering cellular collection. Understanding these fundamentals is vital for advancing treatment efficacy and patient outcomes.
Purity Analysis Methods For Synthetic Prime Editing Guide RNAs
9/8/2023

Develop a fast, easy workflow for the purity analysis of complex pegRNA molecules along with a robust denaturing technique for pegRNA with high levels of secondary structure.
Handling Protocols: Key Considerations In The Highly Potent API Market
5/12/2025

Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.
Single-Use vs. Stainless Steel Debate In Biopharmaceutical Manufacturing
9/1/2023

Investigate the advantages and disadvantages of single-use technologies and stainless steel systems with a focus on performance, adaptability, and economics.
Extractables And Leachables Assessment For Single-Use Systems
4/14/2025

Efforts to enhance biopharmaceutical manufacturing focus on boosting production capacity sustainably and economically. Explore how optimizing processes with single-use solutions and monitoring leachables ensures product quality.

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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.