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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.

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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

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

Challenges, Methods, And Solutions For Obtaining Optimal Starting Material
For innovative treatments like CAR-T and stem cell transplants, optimal starting material is key. Understanding collection challenges and new solutions helps ensure the best foundation for these therapies.

Rapid, Seamless Upstream Process Development And Scale-Up For CHO-K1 Cells
6/28/2024

Accelerate your biotech company's scale-up process while delivering consistent and strong cell growth, productivity, and product quality.
Stability Services
4/28/2025

Dive into a summary of stability considerations and process examples for recombinant proteins, mAbs, gene therapy, and subunit vaccines.
Enhance Virus Clearance Process Capability With Biodegradable Detergent
11/15/2023

Learn more about an effective, biodegradable solution for the viral inactivation process that controls protein impurities and is compatible with downstream unit operations.
Improving API Solubility
3/3/2025

Ensuring adequate solubility is crucial for small molecule drugs' effectiveness. Find out how poor solubility remains a significant challenge, potentially hindering medications from reaching the market.
Overcoming Barriers To Membrane Technology: Demonstrating Protein A Affinity Capture Quality, Process Similarity
3/25/2025

Explore how the interchangeable use of Protein A membrane and resin media can streamline your bioprocessing workflows, ensuring efficient, scalable, and high-quality manufacturing from lab scale to full-scale production.

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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.