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UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk

Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

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EDITOR'S DESK

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.

FDA Releases Draft Guidance To Accelerate Biosimilar Development

New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.

Supporting The Next Generation Of ADCs

Experts discuss innovation in antibody-drug conjugate (ADC) technology and how these impact CMC strategy. This summary captures key takeaways from the Bioprocess Online Live event "Evolving CMC Strategies To Enable Next-Gen ADCs."

GUEST COLUMNISTS

FDA's Final NDC Rule Provides A 900-Year Supply Of Label Codes
FDA won't offer a waiver process or phased implementation. Instead, the agency is providing a seven-year runway to transition to a new labeling format.
All The Ways Global Biopharma Still Grapples With Annex 1
Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.
Clearing The Fog On New First Air Visualization Expectations
Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.
FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address
For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework. The public comment period ends May 8.
Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.
Where Contamination Control Really Breaks Down In Practice
Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.
Trends In FDA FY 2025 Warning Letters
The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends.
SUS Interchangeability Assessment And Qualification Best Practices
Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.

BIOPROCESSING WHITE PAPERS

Application Of Plant And Process Models
Explore innovative process and facility models that optimize efficiency, sustainability, and cost-effectiveness in biopharmaceutical manufacturing.

Elevating mRNA Manufacturing Toward GMP-Readiness
8/27/2025

The mRNA Technology Transfer Program empowers LMICs with scalable vaccine production. Learn about a partnership that drives innovation in mRNA and sets a global blueprint for equitable health access.
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.
Ready To Demystify Organoids?
7/1/2025

Organoids are transforming biomedical research. Explore their top applications, research workflows, key challenges, and dissociation techniques in this comprehensive guide to personalized medicine.
FIH: Reach Milestones Sooner With A Technology-Driven Approach
2/12/2026

Accelerate your path to IND and FiH with AI-driven design, advanced cell line engineering, and intensified processes delivering high titers in 9–14 months.
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.

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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.