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Ever Wonder What Running A $50B Capital Facilities Project Feels Like?

Eli Lilly and Company's projects in the U.S. include greenfield sites where little infrastructure exists. Here's how the company's approaching the challenge.

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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FDA Releases Draft Guidance To Accelerate Biosimilar Development

New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.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

February 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
COGs And Biology, Two Endpoints Needlessly At Odds In Advanced Therapy
Problems emerge when development, manufacturing, and clinical priorities fail to converge in cell and gene therapy development.
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.

BIOPROCESSING WHITE PAPERS

Process Scale Column Packing Instructions
Explore a comprehensive guide to using DurA Cycle A50, a high-capacity, alkaline stable protein A affinity chromatography resin for the downstream processing of mAbs and recombinant proteins.

A Toolbox For An Effective Tech Transfer
7/23/2025

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.
The Value Of Engaging A Single CDMO For Comprehensive Biologics Services
2/4/2026

By forging strategic partnerships with comprehensive CDMOs, see how emerging biopharma firms can navigate through early-phase development and ensure a smooth transition to clinical advancement.
Process Development For Lyophilized Products
10/16/2024

Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.
Producing MSC-Derived Cell Therapies From Isolation To Large-Scale Expansion
8/4/2025

Explore the journey of producing MSC-derived cell therapies, from initial isolation and expansion to final product formulation and storage, and learn how to optimize each step.
Digital Solutions Enhance Pharmaceutical Manufacturing Performance
2/6/2026

Personalised therapies and advanced technologies are reshaping manufacturing. Explore how intelligent automation can improve flexibility, strengthen data integrity, and accelerate production.

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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.