Bioprocess Online for bioanalytics, biopurification, bioproduction

Minimizing The Impact Of Human Errors Using Relational Risk Analysis

This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

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EDITOR'S DESK

Governor Josh Shapiro On Supporting Biomanufacturing In Pennsylvania
Bioprocess Online's coverage of Governor Josh Shapiro’s fireside chat with BIO CEO, John Crowley, at the 2025 BIO International Convention.

How CGT Leaders Are Reducing Failures, Scaling Processes, And Overcoming Regulatory Friction

Industry leaders share their philosophy on reducing product failure, embracing AI, and building dynamic teams to stay ahead of the curve to bring curative CGT therapies to patients.

Finding Compatibility In Love And CDMO Partnerships

Just like people, some sponsor-CDMO partnerships can be matches made in heaven. Others, not so much. See what experts have to say about finding the right CDMO and building a successful partnership together.

Five Takeaways from BIO 2025 and Why You Should Stay Tuned

New chief editor of Drug Discovery Online shares insights from BIO 2025’s global biotech gathering and spotlights the impacts to early-stage drug research.

Lonza Bets On Biologics. What's It Mean For You?

It’s a large and universally recognizable CDMO, so this matters. Swiss-based powerhouse Lonza will increase its focus on biologics, and “advanced synthesis” including for antibody-drug conjugates (ADCs), cell and gene therapies (CGT), and mRNA therapeutics. Will other CDMOs follow suit? What's this say about the future of development outsourcing and our industry?

GUEST COLUMNISTS

Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities
In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.
FDA Priority Voucher Program Submissions Window Opens On New Website
The Commissioner's National Priority Voucher program is accepting applications. Experts predict brisk competition since the agency is only awarding five vouchers for now.
5 Cs For Responding To FDA-483s — Strategies For Effective Compliance And Resolution
Former FDA Director of Bioresearch Monitoring Division (West) Eric Pittman, MBA, shares his top five tips for responding to FDA-483s.
Outsourced, In-House, Or A Combo: An Agile Recruiting Strategy Fuels Growth In Pharmas And Biotechs
There are different staffing options for building an agile and scalable team that can quickly react to shifting needs, resources, and funding.
5 Best Practices For Improving AI Literacy In A GxP Environment
ERA Sciences' Ben O'Brien shares five tips to improve pharma and biotech companies' AI literacy when operating in a GxP environment.
AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies
A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.
All Of Us Need To Be Rooting For The FDA
In light of FDA leadership changes and operational updates, FDA Matters' Steven Grossman asks us all to slow down and consider why we should be cheering on, not tearing down, the present-day FDA.
Here's What Limits AI's Outlook For Replacing Knowledge Workers
Even after AI developers clean up hallucinations and other short-term issues, a large-scale workforce replacement faces a few intractable obstacles.

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.

Rapid Discovery And Characterization Of Monoclonal Antibodies Against The SARS-CoV-2 Delta Spike Protein
4/23/2025

Delve into the intricate workflow employed for the discovery and characterization of monoclonal antibodies (mAbs) targeting the Delta spike protein.
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.
Incremental Adoption Of A Modular Operations Platform
1/31/2025

Discover the potential of a modular operations platform that scales the benefits of digitalization and aids organizations in implementing a unified data strategy to realize the full potential of smart manufacturing.
Process Scale Column Packing Instructions
6/12/2024

Explore a comprehensive guide to using DurA Cycle A50, a high-capacity, alkaline stable protein A affinity chromatography resin for the downstream processing of mAbs and recombinant proteins.
Opportunities In Preclinical Development
11/4/2024

Every domain produces critical data and this data and contexual information should be captured and managed in the most effective and robust manner.

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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.