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Why Your MES RFP Is Failing Before It Starts

Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.

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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

Gaining An Edge In GLP-1 Production
The shortage-driven production of GLP-1 drugs of the past few years is giving way to a long-term operation model characterized by digital enablement and supply chain resilience.
Inside March Biosciences' CD5-Targeting CAR-T Approach
Fratricide is one of the key reasons T-cell therapies targeting T-cell malignancies have faltered. March's approach aims to solve that with its MB-105 candidate.
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.
The Stepwise Path Lilly Mapped From Paper To Digital Logbooks
Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.
Minimizing Regulatory Risk For Biologics Manufacturing Changes
Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.
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.

BIOPROCESSING WHITE PAPERS

Criteria For Effective Bioprocess Scale-Up
Discover four essential bioprocess scale-up criteria and how each balances hydrodynamics, shear, and mass transfer across manufacturing scales.

How Automation Is Driving Carbon Reduction
10/21/2025

Manufacturers can cut emissions and boost efficiency by modernizing energy and utility systems. Explore how smart automation and analytics offer fast ROI and long-term sustainability.
Is Mannitol Hemihydrate Detrimental To Protein Stability?
10/16/2024

Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.
How Lipid Nanoparticles Enable Next-Gen Delivery
10/20/2025

Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.
A Comprehensive Solution For Adventitious Agent Testing
2/13/2026

Modern sequencing methods offer sensitive detection of adventitious and species‑specific viruses. Learn how targeted and non‑targeted NGS approaches improve confidence in cell bank characterization.
Stabilization Of RNA-Loaded Lipid Nanoparticles By Lyophilization
8/15/2025

Discover how lyophilization enhances RNA-based therapeutics by enabling storage at higher temperatures, which simplifies cold-chain logistics while preserving nanoparticle integrity and biological activity.

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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.