Bioprocess Online for bioanalytics, biopurification, bioproduction

Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign

The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.

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EDITOR'S DESK

From Biology Grad To Manufacturing Guru
Stephanie Wimberly graduated from Howard University in 2012 with a degree in biology. What was next? An online search turned up an intriguing area – pharmaceutical manufacturing. “It was manufacturing,” she thought, “but I could still help patients." It was a fortuitous start. This young female professional with a penchant for helping others started a manufacturing career that has wound through GSK, and leadership roles at Shire/Takeda. Now as a manufacturing consultant, here is her advice for manufacturing outsourcing, and careers.

Taking The First Steps Towards Digitalizing Biopharma Development

AbbVie's head of biologics purification development and digitization teams, Moiz Diwan, Ph.D., and independent technology consultant Kat Kozyrytska share their thoughts on AI and smart technology adoption in this recap of the Bioprocess Online Live event, “How Digital Tools Are Accelerating Biopharma Development.”

Bioprocess Online's 2025 Editorial Reflections

Bioprocess Online's chief editor, Tyler Menichiello, reflects on the year and provides a preview of what to expect in 2026.

We're A Virtual Biotech. CDMOs Should Treat Us As A Priority

Chief Editor Louis Garguilo says he's sure some readers will smirk at our headline. CDMOs are running a business; they may attempt to treat all customers equally, but they focus where the most financial gain is. That's usually with bigger clients. Nonetheless, according to a very experienced outsourcing professional, there's nothing humorous here at all.

FDA Releases Draft Guidance To Accelerate Biosimilar Development

New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.

GUEST COLUMNISTS

Generative AI Can Write The Code, But Who Builds In The Quality?
Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.
UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk
Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.
February 2026 — 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.
COGs And Biology, Two Endpoints Needlessly At Odds In Advanced Therapy
Problems emerge when development, manufacturing, and clinical priorities fail to converge in cell and gene therapy development.
FDA's Final NDC Rule Provides A 900-Year Supply Of Label Codes
FDA won't offer a waiver process or phased implementation. Instead, the agency is providing a seven-year runway to transition to a new labeling format.
All The Ways Global Biopharma Still Grapples With Annex 1
Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.
Clearing The Fog On New First Air Visualization Expectations
Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.
FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address
For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework. The public comment period ends May 8.

BIOPROCESSING WHITE PAPERS

How To Take Your Process To A Closed System
Understand the critical considerations for implementing closed systems in bioproduction, from vessel selection to workflow customization for optimal efficiency and safety.

Generate CHO-K1 GFP-Expressing Cells For Cell Line Development Workflow
11/7/2025

Discover a high-efficiency workflow for generating GFP-expressing CHO-K1 clones using automated single-cell dispensing to achieve 93% isolation success and stable expression in under five weeks.
The Importance Of Quality In Raw Material Selection
1/16/2025

Learn how to select high-quality raw materials for cell-based manufacturing in this exploration of the criticality of raw materials, from preclinical development to commercialization.
Expanding Translational Research Concepts With Genedata Profiler
11/26/2024

The biopharma industry leverages Genedata Profiler to integrate, curate, and analyze diverse R&D data, enabling collaborative, compliant, and AI-driven translational research to optimize drug development.
ICH Q12 Implementation: Regulatory Intelligence And PACM Agility
7/9/2024

Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.
What Pharma And Biopharma Should Know About Container Closure Integrity
8/1/2024

Explore high voltage leak detection, headspace analysis, and vacuum and pressure decay as applied in pharmaceutical 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.