Bioprocess Online for bioanalytics, biopurification, bioproduction

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.

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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FDA Releases Draft Guidance To Accelerate Biosimilar Development

New FDA draft guidance aims to reduce the timeline and cost of developing biosimilars.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

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.
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Accelerating Technology Diffusion In Cell And Gene Therapy
Unlike most other drugs, advanced therapies require complex, purpose-built supply chain networks. Making them requires cross-sector collaboration.
5 QMS Blind Spots You Should Know About
Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.
New MIT Consortium Links Innovation With Real-World Biomanufacturing
In one area, the Initiative for New Manufacturing is exploring whether microfactories, championed by the EV industry, can help biopharma iterate facility design faster.
Dynamic Flux Analysis Offers Faster Metabolic Modeling Than DOE
By continuously analyzing spent media, researchers can estimate reaction rates at regular time points, providing a granular view of cell metabolism.
Green Supply Chains Rarely Start With A Pledge; Target Waste Instead
Effective sustainability strategies in pharma supply chains reduce rework and overage. Three leakage points offer the most practical starting point for rooting out waste.
The Real Reason We Haven't Fully Automated Cell Therapy Yet
Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.

BIOPROCESSING WHITE PAPERS

Digital Innovation And Sustainability Are Redefining Biomanufacturing
Next Generation Manufacturing (NGM) integrates advanced process design, digital innovation, and strategic facility planning to facilitate agile, efficient, and sustainable biopharmaceutical production.

Incremental Adoption Of A Modular Operations Platform
1/31/2025

Discover the potential of a modular operations platform that scales the benefits of digitalization and aids organizations in implementing a unified data strategy to realize the full potential of smart manufacturing.
The Impact Of Annex 1 (2022) On Sterility Assurance
4/24/2025

Airflow visualization studies, crucial for GMP compliance, validate unidirectional airflow effectiveness in contamination control. Discover their enhanced role in quality by design and revised Annex 1 guidelines.
Epigenetics Application Guide: RNA Modifications
9/26/2024

Learn about the rapidly evolving field of RNA modifications, including innovative techniques like miCLIP and RIP for mapping chemical modifications and understanding RNA’s role in cellular processes.
Methods For Determining Equipment Capability Of Freeze-Dryers
10/16/2024

Observe two experimental methods for determining choked flow: the minimum controllable pressure method and the choke point method.
Engineering Reliability In Cell Therapy Manufacturing
2/3/2026

A cell therapy manufacturing model built on precision planning, digital execution, lifecycle‑ready CMC systems, and transparent collaboration to achieve high reliability and reduce variability across programs.

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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.