Bioprocess Online for bioanalytics, biopurification, bioproduction

Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs

This article assembles an industrywide “platform” knowledge base on the impact of parameters across unit operations in a standard mAb process.

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EDITOR'S DESK

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.

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.

GUEST COLUMNISTS

Why Do So Few Cell Therapies Make The Leap From Lab To GMP?
Among other reasons, academic centers have access to sophisticated technology. In contrast, manufacturing suites must use established, validated methods.
Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.
The Transition To E-Labeling Is More Than Uploading PDFs
Despite tight restrictions, patchwork regulations, and an unclear timeline, one researcher says we're heading toward fully-digitalized drug labels.
Are You Still Evaluating CMOs When You Really Need A CDMO?
Outsourcing adds capacity and specialized knowledge to your supply chain. But contractors come in several types. Here's how to pick the right one.
Here's A Thought: What If Gene Editing Didn't Use Bacterial Enzymes?
Citing the dismally few wins for CRISPR/Cas9 and other gene editing systems, one scientist proposes delivering zinc finger DNA-binding peptides using AAV6 vectors.
Dual Membrane Preconditioning Can Improve Concentration, Cut HCPs
Research from Penn State, the FDA, and Takeda shows how combination filtration and purification steps improve output and reduce impurities.
Analyzing CAR-T Surface Proteins With Immunoprecipitation Coupled With Mass Spectrometry
Among other benefits, the approach can help compare CAR constructs, evaluate the effects of manufacturing processes, and monitor changes in protein interactions.
Program Manager Alignment And Integration: Best Practices When Working With A CDMO
This Q&A discusses best practices for integrating program managers into a sponsor company and how program managers help bridge the gaps between various stakeholders.

BIOPROCESSING WHITE PAPERS

Quality By Design (QbD) For Biologics From A CDMO Perspective
Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

2025 State Of Validation: Key Insights
5/14/2025

Discover what’s driving change in validation in your industry in 2025 by exploring key Insights for a first look at this year’s top trends, challenges, and opportunities in validation.
Simplifying The Transition To Multi-Column Chromatography
4/5/2024

Explore the advantages of multi-column chromatography and how to transfer your process from batch to an intensified system, step-by-step.
Advancing A LNP Formulation To Clinical And Commercial Manufacturing
3/25/2024

Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
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.
The Future Of Cleaning Validation
7/23/2025

Explore evolving cleaning validation strategies in life sciences, from regulatory foundations to digital innovations, and discover how agile, risk-based approaches can enhance compliance and efficiency.

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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.