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The 3 Phases of QRM – An Inspector's View

Quality resource management has three phases: assessment, control, and review. The experts at GMP Compliance Advisor bring us this breakdown of all of them.

EDITOR'S DESK

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.

2025 Cell Therapy Outlook From BPI West

Bioprocess Online and Cell & Gene spoke with Takeda’s Amy Shaw at BPI West to discuss the industry and her key takeaways from the conference.

Using AI And ML To Gain Insight Into Optimal Glycoforms

Bioprocess Online asked Nathan Lewis, Ph.D., to briefly explain the research he presented at BPI West 2025.

Impressions And Takeaways From BPI West 2025

Editor Tyler Menichiello reviews the most compelling topics and sessions from this year's BioProcess International U.S. West.

GUEST COLUMNISTS

April 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.
Incorporating AI Tools Into Downstream Process Optimization
Data-driven, hybrid modeling complements mechanistic thinking by reducing computational load for faster decision-making when time is a critical consideration.
A Road Map For PAT Monitoring And Control
Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.
Is Early Automation The Key To Scalable Cell Therapy Manufacturing?
Picking which phase to introduce automation has serious implications, and the calculation is unique for every product. Here are some important considerations.
Hard Lessons In Parenteral Automatic Visual Inspection
Complex problems can have simple solutions. That's what a team at AstraZeneca found when they set out to reduce false rejection rates in vials containing mAbs.
The EU Biotech Act Has Been Delayed — Here's What That Means
First due at the end of 2025, the act has been delayed until late 2026, which suggests key issues that many say hobble innovation will go unaddressed for longer.
From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025
The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.
Addressing Human "Error" In Pharma Manufacturing
Why is it that managers at pharma manufacturing sites continue to be frustrated by what could be labeled as “avoidable” human errors, and what can companies do about it? Let's investigate.

BIOPROCESSING WHITE PAPERS

Improve Your Molecular Cloning Process With Synthetic Biology Automation
Explore the promising field of synthetic biology, the hurdles manufacturers face with it's workflow, and how automation can help accelerating throughput and walkaway time.

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.
Fc-fusion Cell Line Development: Expression And Analytical Strategies
5/15/2023

Understand high titer expression of Fc-fusion proteins using the Apollo™ X platform coupled with integrated quality assessments, enhancing support through the predicted growth in Fc-fusion clinical applications.
Considerations And Options For Prefilled Syringes
10/16/2024

Explore the benefits of prefilled syringes to enhance product convenience, reduce drug waste, and streamline your pharmaceutical manufacturing process.
Three Key Strategies To Guide Efficient And Effective Recall Management
2/18/2025

Discover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.
Critical Considerations For Buffer Preparation
8/7/2023

Learn about the steps of buffer development, supply approach and strategy selection, choosing between in-house and outsourcing buffer activities, and other related buffer use topics.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

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.