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Sanofi's Digitalization Road Trip Shifts Into High Gear

The company's head of manufacturing discusses their latest investments in AI and automation, plus offers tips on how any company can start adopting advanced technology.

Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms
The Regulatory Imperative To Improve Environmental And Sustainability Stewardship In Biopharma

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EDITOR'S DESK

Unlocking The Pharmacological Potential Of Antibodies
Abalone Bio's CEO and co-founder, Richard Yu, Ph.D., explains the company's Functional Antibody Selection Technology (FAST) platform and its approach to developing a pipeline of G protein-coupled receptor (GPCR) mAbs.

Tech Transfer 2025 – A High-Stakes Game Of Trust

Trust us. You'll want to read this editorial from Chief Editor Louis Garguilo, who was (gently) reminded he hadn't visited the subject of tech transfer in a while. He answers the questions both sponsors and CDMOs ask to gain the trust to make a tech transfer work for both sides.

How Lumen Is Putting The "Farm" In Biopharma

Lumen Bioscience's SVP of production and development, Craig Behnke, Ph.D., explains how the company is cutting costs and rethinking upstream manufacturing with its algae-based production platform.

The Safety Potential Of Conditionally Active Biologics

Conditionally active biologics (CABs) are an emerging class of therapies that can reduce off-target toxicity in the clinic, and they were a topic of conversation at the 2025 BIO International Convention.

CDMOs Should Stop Stringing Biotechs Along

Biotechs, first working closely with a CDMO’s sales manager, experience subsequent and sudden rejections of their projects. Did some of you just wince? If so, that might be because we are again hearing of a problem with sudden rejections after protracted discussions and even site visits. Part two on what is one of the biggest problems for outsourcing today.

GUEST COLUMNISTS

How You And Your CDMO Should Leverage Contamination Control Strategies For Competitive Advantage
It is no longer sufficient to just meet compliance requirements; a proactive, risk-based approach to contamination control is now a differentiating factor that enhances operational efficiency and more. For biotech companies evaluating CDMOs, this shift is critical.
Leveraging AI And Data Science For Biologics Characterization
Modern analytical tools produce more data than we know what do with. Artificial intelligence helps condense, interpret, and utilize what's most meaningful.
Operating And Maintaining Pharmaceutical Gas Distribution Systems
Drug manufacturers face stringent requirements when using gas that comes into direct contact with the product. This guide discusses operation, maintenance, and monitoring of gas systems.
August 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.
What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish
Choosing the right CDMO partner for a biotech product isn’t about “capacity at a good price”; it’s about a partner with the right mix of technical expertise, regulatory track record, and more.
How AbbVie's Digital Transformation Brought Platform Knowledge Closer
A custom-built digital ecosystem reduced the time spent on documentation in AbbVie's bioprocess development labs by about 70% for some experiment types.
The New FDA Era Of Radical Transparency And Pervasive Oversight
The first half of 2025 has been transformative for biopharmaceutical quality and regulatory affairs, with the FDA leading the charge with four significant changes. Curadian Group's David Grote discusses implications for all four.
A Case Study In Continuous Process Verification
CPV can strengthen the bridge between compliance and continuous improvement. In this scenario, a hypothetical lab sets out to improve process yields and efficiency.

BIOPROCESSING WHITE PAPERS

A Shift Towards Biofluorescent Particle Counters In Manufacturing
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.

A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk
10/10/2024

Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
Tablet Manufacturing Technologies For Solid Drug Formulation
4/2/2025

Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.
Revolutionizing Particle Characterization With Image Analysis And ML
9/27/2023

The biopharmaceutical industry is increasingly employing micro-flow imaging for particle characterization, owing to the superior insights it can afford into product quality and process controls.
The Complete Guide To Immunohistochemistry
9/24/2024

Immunohistochemistry (IHC) is a tool for visualizing the distribution and localization of antigens within tissue sections. Learn about IHC sample preparation, detection and amplification systems, and more.
Microbial Challenge In-Use Studies
6/13/2024

Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

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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.