Bioprocess Online for bioanalytics, biopurification, bioproduction

Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative

This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

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EDITOR'S DESK

Advising The Biotech C-Suite To Reconsider Quality
“I assist C-suite executives to transfer quality from a painful cost center to a competitive asset." It's the type of bold statement that draws one's attention. Chief Editor Louis Garguilo asked David Grote on what his assertion means materially – and how that’s applied to working with CDMOs. Here's their discussion that focuses on a transformation that moves executives from regarding quality as ‘overhead’ to recognizing quality as “an operational element for business advantage.”

A Biotech Business Model That's Investor-Friendly

For biotechs meeting with current and potential investors, says Edward Ahn, CEO, Medipost Inc., “it should be about demonstrating your business continuity more than anything else.” Investors know, he says, “any supply chain may be fragile.” Indeed, Ahn’s organization has put in place an intriguing business model to address such concerns. It includes owning part of a CDMO.

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.

GUEST COLUMNISTS

Selecting The Right eQMS To Maximize Quality Maturity
Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.
Do Changes Signal The End Of Biosimilar Regulatory Redundancy?
First came excitement over the looming patent cliff. Then, FDA and EMA took big swings at what many have called redundant work. Combined, they make a more attractive environment for biosimilar developers.
How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT
Patient access often gets mischaracterized solely as a cost and pricing issue. A discussion among industry leaders reaches a deeper, more complex conclusion.
FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing
The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.
Validating Candel's BLA-Ready Analytics Profile
The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.
Mapping Candel Therapeutics' Sprint To The BLA Finish Line
Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.
Expanding The IV → SC Framework: What Reformulation Really Means
IV → SC is a system design challenge. Success depends on aligning formulation, device, manufacturing, and clinical strategy early to avoid costly failures and redesigns.
Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network
Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs.

BIOPROCESSING WHITE PAPERS

Streamline Your AAV Process With A Production Platform
AAVs are reshaping gene therapy, but scaling production introduces complexity. Learn how upstream process optimization can improve yield, consistency, and speed to meet growing demands.

Optimal Microbial Sampling Criteria
6/24/2025

Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.
Single-Use Technology And Environmental Responsibility In Biopharmaceuticals
3/27/2025

Learn about strategies such as regional manufacturing and advanced single-use systems and their potential to minimize carbon footprint and enhance sustainable biomanufacturing.
Standardized Extraction Protocol Per USP <665>: Bridging Regulatory Expectations And Industry Best Practices
4/29/2026

View how to implement USP <665> extractables testing, align with global E&L standards, and apply risk-based strategies to ensure regulatory compliance and patient safety.
Application Of Plant And Process Models
1/22/2025

Explore innovative process and facility models that optimize efficiency, sustainability, and cost-effectiveness in biopharmaceutical manufacturing.
How To Take Your Process To A Closed System
4/22/2025

Understand the critical considerations for implementing closed systems in bioproduction, from vessel selection to workflow customization for optimal efficiency and safety.

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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.