Bioprocess Online for bioanalytics, biopurification, bioproduction

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Lessons In Quality From Sanofi's Plai.qa

The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.

EDITOR'S DESK

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.

The Death Of A Dogma: David Baltimore And Lessons For Modern Drug Discovery

Nobel laureate, David Baltimore passed away at 87 years old, on September 6, 2025. He was widely regarded as a scientific visionary who at just 37, co-discovered reverse transcriptase, an enzyme that flipped molecular biology on its head by showing that genetic information could flow from RNA back to DNA, not just the other way around.

GUEST COLUMNISTS

Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk
Many life science organizations collect sensitive data through outdated web forms, exposing companies to critical vulnerabilities, data breaches, regulatory penalties, and more.
A Hierarchy of Metrics Brings Strategy Into Biopharma's Daily Work
Information now flows faster than organizations can think about it, and without deliberate structure, decision-making becomes reactive rather than reflective.
An End-To-End Automated HTP Platform For Cell Line Optimization
Bristol Myers Squibb's high-throughput stable CHO platform produces high-titer, high-quality material in a fraction of the conventional timeline.
Here's What You Need To Know About The Access Consortium Pathway
Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.
FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK
The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.
Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations
A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”
AI Is Not The CMC Revolution You're Looking For, And That's OK
Advanced therapy development today is less about big funding, more about frugality. Artificial intelligence unlocks a competitive advantage.
Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development
The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.

BIOPROCESSING WHITE PAPERS

Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGT
This paper underscores the 4D-Nucleofector® LV Unit as a pivotal tool for translating genetic modification technologies into scalable, safe, and effective therapeutic solutions.

Designing A Disinfectant Study For Your Cleanroom
5/14/2024

Disinfectant efficacy studies are crucial for safeguarding the sterility of your manufacturing facilities. Gain expert insights into the intricacies of these important studies and how to design one.
The Effect Of Mixing Homogeneity In Retentate Vessel
8/5/2025

Discover a novel analytical method enhancing TFF diafiltration insights that deliver superior mixing, reliable scale-up, and breakthrough interpretation of diavolume performance.
Innovation And Evolution Of Affinity Chromatography Resins For Monoclonal Antibody Purification
9/30/2025

Discover how innovations in ligand design and resin manufacturing have improved monoclonal antibody purification by enhancing selectivity, stability, and process economics.
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.
Rapid Discovery And Characterization Of Monoclonal Antibodies Against The SARS-CoV-2 Delta Spike Protein
4/23/2025

Delve into the intricate workflow employed for the discovery and characterization of monoclonal antibodies (mAbs) targeting the Delta spike protein.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

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.