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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.

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EDITOR'S DESK

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.

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.

GUEST COLUMNISTS

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.
Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation
Scientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence.
U.S. Pharma Tariffs And MFN Become Law After April 2 Update
Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.
How To Implement Post-Approval Changes On A Global Level
To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.

BIOPROCESSING WHITE PAPERS

The Effect Of Conventional Cooling Versus Controlled Ice Nucleation On Primary Drying Time
See how controlled ice nucleation shortens lyophilization cycles, supports higher drying temperatures, and reduces complexity for amorphous and mixed formulations without sacrificing quality.

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.
Why Biopharma Breakthroughs Aren't Moving The Market
10/20/2025

Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.
Advances In Regulations For Viable Environmental Monitoring
2/21/2025

Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.
Optimize DNA Clearance In High-Salt, GMP-Grade Purification Processes
9/16/2025

Efficient hcDNA removal is vital for therapeutic safety and compliance. Discover how salt-active enzymes support high-salt purification workflows to help manufacturers meet strict regulatory standards.
Build An AAV8 Platform: Lessons From A Collaborative Development Journey
11/5/2025

Explore how a modular AAV8 platform enables scalable, GMP-ready gene therapy manufacturing with reproducible outcomes, streamlined tech transfer, and adaptability across serotypes.

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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.