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100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing

Research Manager Mathini Ilancheran explores the effects of U.S. drug tariffs on global supply chains, multinational pharma firms, and critical partners across drug development.

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EDITOR'S DESK

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.

Single-Use Standardization Starts At Home

During a Bioprocess Online Live event, “Single-Use Harmonization Needs A Tune Up," panelists discuss a way forward for the industry to unlock the true flexibility and promise of single-use technology.

Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured

An element of the 2025 BioPlan Associates annual report and survey took Chief Editor Louis Garguilo by surprise. The report intimates that biopharmaceutical manufacturing faces a fractured CDMO market. Despite solid data to back that assertion up, Garguilo presents a very different view, one based on what many readers have expressed.

Unlocking The Pharmacological Potential Of Antibodies

Abalone Bio's CEO and co-founder, Richard Yu, Ph.D., explains the company's Functional Antibody Selection Technology (FAST) platform and its approach to developing a pipeline of G protein-coupled receptor (GPCR) mAbs.

GUEST COLUMNISTS

CRISPR And iPSC Disease Modeling And Drug Screening
iPSCs combined with the CRISPR-Cas9 gene editing system can construct or repair mutations and establish highly accurate, controllable in vitro models.
Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards
This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.
Application Of CRISPR Technology In iPSC Gene Correction
The CRISPR-iPSC combination is becoming a core tool for precision medicine with advanced editing efficiency, differentiation control, and safety profiles.
What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma?
Deciding what is good enough to get started can support the mindset of building something without sacrificing quality, functionality, or safety.
Fermentation Of Live Biotherapeutic Products In cGMP Environments
We follow the journey from master cell bank to large-scale anaerobic fermentation, highlighting the unique needs for working with oxygen-sensitive, strictly anaerobic therapeutic microbes in a cGMP setting.
Survey: 30% Of Biopharmas Cite Cost, Productivity As Top Priorities
Both focus areas aim at the same outcome, stronger economics and sustainable competitiveness, according to BioPlan Associates' 22nd Annual Biomanufacturing Report.
Import Product Specifications And Drug Registration Testing For China
This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).
Navigating Regulatory Frameworks For Allogeneic CAR-NK Control Strategies
The regulatory landscape for this emerging modality is vast and tortuous. One regulatory CMC expert, a former FDA reviewer, helps us with a path through it all.

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.

The GxP Digital Maturity Model
8/8/2025

Explore how the GMP Digital Maturity Model guides life sciences companies through five stages to improve compliance, efficiency, and profitability with strategic digital adoption.
Leveraging The Immunological Diversity Of The Pentamice® Platform For Covid-19 Antibody Discovery
5/16/2024

Consider this alternative immunization approach — the PentaMice platform, a collection of five wildtype mouse strains bred in-house for increased MHC class II diversity — and how we're leveraging it for COVID-19 antibody discovery.
Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators
4/28/2025

Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.
Quantitation Of Monoclonal Antibodies In Serum
2/8/2024

Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.
Three Key Strategies To Guide Efficient And Effective Recall Management
2/18/2025

Discover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.

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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.