Bioprocess Online for bioanalytics, biopurification, bioproduction

Earth Diverse unity-GettyImages-2189085103

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.

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

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.
New Guide Aims To Build Robust Framework For Digital Validation Tools
The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.
Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms
The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.
How Sethera Harnesses A Promiscuous Enzyme To Make Recombinant Peptides
A class of enzymes previously believed to be specific and intolerant of change might actually have broad applicability.
Takeda Reimagines Biopharma Quality For The Digital Age
Artificial intelligence, even in its current form, is especially good at synthesizing large data sets. Here's how one company makes the most of it.

BIOPROCESSING WHITE PAPERS

Designing A Disinfectant Study For Your Cleanroom
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.

Producing MSC-Derived Cell Therapies From Isolation To Large-Scale Expansion
8/4/2025

Explore the journey of producing MSC-derived cell therapies, from initial isolation and expansion to final product formulation and storage, and learn how to optimize each step.
Optimizing Poloxamer 188
1/13/2025

Poloxamer 188 stabilizes proteins in liquid formulations and protects cells from shear stress. Molecular weight and hydrophobicity variations influence its effectiveness in different biopharmaceutical applications.
Optimizing Aliquoting For Robust Cell And Gene Therapy Processes
6/3/2024

Explore the challenges of liquid handling in cell and gene therapy processes as well as innovative solutions to simplify aliquoting in modern bioprocesses.
Calculating The ROI Of EAM/CMMS For Pharma Manufacturers And CDMOs
10/6/2025

Learn how modern EAM and CMMS systems help pharma manufacturers reduce risk, improve compliance, and cut costs, as well as nine signs it’s time to move beyond outdated asset management practices.
Best Practices In Formulation And Lyophilization Development: Proteins, mAbs And ADCs
10/16/2024

Discover how advancements in pharmaceutical freeze-drying are reshaping the process through better product understanding, precise process control, and innovations in equipment efficiency.

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.