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The Systems And Choreography Needed For Grade B ATMP Material Transfer

Traditional material air locks often fail to account for the sheer throughput needed for cell therapy workflows. These design tips help prevent traffic jams.

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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FDA Releases Draft Guidance To Accelerate Biosimilar Development

New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.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

Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
Eli Lilly and Company's projects in the U.S. include greenfield sites where little infrastructure exists. Here's how the company's approaching the challenge.
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.

BIOPROCESSING WHITE PAPERS

Time To Intensify: Taking mAb Manufacturing To The Next Level
Explore how process intensification can revolutionize monoclonal antibody manufacturing to boost productivity, cut costs, and enhance sustainability with scalable strategies and real-world results.

Understand Fluorescence And How It Enhances Scientific Exploration
9/24/2024

Deepen your understanding of fluorescence for research, and gain valuable insight into how to select appropriate fluorophores and fluorescent proteins for your experiments.
Three Steps To Digital Transformation In Life Sciences Manufacturing
1/30/2025

Explore trends that are transforming the industry, some common speedbumps on the road to innovation, and how a new platform offers unprecedented process transparency and continuous improvement.
Leveraging Life Sciences Data For Intelligent Decision-Making
2/18/2025

Industry 4.0 drives life sciences to prioritize data-driven decision-making by integrating advanced technologies in QMS. Discover how modern data management can improve compliance.
How The Accelerator™ Drug Development Model Enhances eNPV
2/25/2026

Discover how an integrated CDMO and CRO model can accelerate development timelines, add up to $62.9 million in value, and help you maximize long-term pipeline success with a single, streamlined partner.
2024 Global Biopharma Sustainability Review
9/3/2024

What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?

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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.