Bioprocess Online for bioanalytics, biopurification, bioproduction

Unpacking The EU's Mutual Recognition Agreements For Pharma

MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

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EDITOR'S DESK

The 9 Fastest-Growing Outsourcing Segments
Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.

AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing

At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.

On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration

AI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.

On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing

Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.

On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D.

DeciBio partner Carl Schoellhammer, Ph.D., speaks on the record with Bioprocess Online's chief editor Tyler Menichiello at the 2025 BioProcess International conference in Boston.

GUEST COLUMNISTS

Why Your MVP And Its Evolution Matters To Manufacturing
Minimum viable product is one of the most important inputs to developing a manufacturing process. It defines essentials that matter to the people who make the product.
TFF Offers Ideal Anaerobic, GMP Conditions For LBP Concentration
When configured correctly, TFF provides the gentle processing environment and oxygen protection required for strict anaerobes.
Biotech Wasn't Ready For AI's Speed; Here's How We Catch Up
Computational success is no stand-in for therapeutic readiness. Innovators must learn to discern between models rooted in science and those that speculate.
Strained Manufacturing, Complexity Stymie In Vivo Progress
Explicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational risk.
To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem
The choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.
Ask The Pros — The Latest In HCP Monitoring
Established methods focused on counting all HCPs indiscriminately. Now, a new wave of sophisticated monitoring offers clearer impurity profiles.
Lessons In Quality From Sanofi's Plai.qa
The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.
The Promise And Paradox Of QbD
The difference between QbD as burden and QbD as advantage lies in critical thinking supported by structure — a hierarchy of metrics, toolsets, and tailored platforms.

BIOPROCESSING WHITE PAPERS

A Toolbox For An Effective Tech Transfer
As drug development costs rise, companies are embracing digital-first strategies and Pharma 4.0 principles to streamline operations, enhance tech transfer, and accelerate time-to-market through innovation.

Suspension Culture Improves iPSC Expansion And Pluripotency Phenotype
12/19/2024

Learn about the advantages of 3D suspension culture for iPSC expansion, including enhanced pluripotency and genetic stability. Discover how this technique yields high-quality iPSCs for regenerative cell therapies.
Time To Intensify: Taking mAb Manufacturing To The Next Level
8/19/2025

Explore how process intensification can revolutionize monoclonal antibody manufacturing to boost productivity, cut costs, and enhance sustainability with scalable strategies and real-world results.
Protein Stress Testing
4/28/2025

Start your forced degradation studies early to uncover molecular risks, strengthen product stability, and ensure regulatory-ready development from the start.
The Key To Viral Vector Success
11/11/2024

Establishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.
Beyond Traditional Monoclonal Antibodies
9/24/2025

New antibody formats present new purification challenges due to novel impurity profiles. New methods and media are required to ensure safe, effective, and scalable manufacturing of these biologics.

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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.