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

Providing Enhanced Manufacturing Data To Contracting Companies
The life sciences sector is projected to reach $220 billion by 2030. Examine the growth of CDMOs and CMOs, emphasizing the need for digitalization to meet client demands and regulatory standards.

Streamline Your AAV Process With A Production Platform
10/6/2025

AAVs are reshaping gene therapy, but scaling production introduces complexity. Learn how upstream process optimization can improve yield, consistency, and speed to meet growing demands.
Improving Methodologies For iPSC Manufacturing And Differentiation
9/30/2025

Learn how next-generation workflows are being developed to streamline iPSC manufacturing, enhance differentiation strategies, and overcome the hurdles of scalability and consistency.
ATMP Cryopreservation Done Right - Best Practice In Small Volume Cryo-Freezing
3/11/2025

Explore best practices for cryopreserving small-volume advanced therapy medicinal products (ATMPs), emphasizing sterility, cell viability, and efficiency using innovative single-use systems and aseptic connectors.
Validation And Qualification Approach In New Annex 1 Revision
2/21/2025

The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.
Navigating CMC Regulation For Plasmid DNA In Gene Therapy
5/28/2025

Explore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.

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.