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.

More Featured Editorial

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

Quantitation Of Monoclonal Antibodies In Serum
Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.

Mastering Asset Management In CGT
8/12/2025

Explore how CGT manufacturers can boost compliance, scalability, and efficiency by adopting purpose-built EAM/CMMS platforms tailored to their unique operational and regulatory needs.
How Automation Is Driving Carbon Reduction
10/21/2025

Manufacturers can cut emissions and boost efficiency by modernizing energy and utility systems. Explore how smart automation and analytics offer fast ROI and long-term sustainability.
Tech Transfer At Risk: The Imperative For Digital Maturity, Modernization
12/2/2024

Tech transfer is critical for biopharmaceutical production, but outdated tools can hinder the process. Discover how digital maturity can streamline operations, reduce risks, and accelerate time to market.
Development And Regulation Of Veterinary Monoclonals
2/8/2024

Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.
Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity
2/14/2025

A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.

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.