Process Development

Rigenerand Develops 3D Bioreactor for Extracellular Vesicle Exosomes Production

July 31, 2020

The company has begun development of a 3D bioreactor for the cGMP production of extracellular vesicle exosomes.

Eliminating Residual Impurities Starts with a Strategic Plan

July 01, 2020

Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.

Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data Analytics

June 01, 2020

Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.

NIIMBL Funds Projects with $10 Million for Advances in Biopharma Manufacturing Innovation

May 20, 2020

This latest round of funding adds 14 new technology projects, workforce development, and Global Health Fund projects to NIIMBL's portfolio.

Ensuring Smooth Tech Transfer of Bioprocess Operations

April 01, 2020

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

Orgenesis, ExcellaBio Announce Breakthrough Manufacturing Process for Bioxomes

April 01, 2020

The new patented process results in uniform, scalable production and the ability to deliver cell cargo similar to natural exosomes/extracellular vesicles.

Improving Upstream Predictability

March 02, 2020

Better understanding and control of cell behavior is yielding benefits, upstream and beyond.

The Need for Advanced Process Modeling for New Therapeutic Biologics

February 01, 2020

The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.

Mapping a Route for Cell and Gene Therapy Process Development

January 01, 2020

While cell and gene therapies differ in many ways, some of the best practices for process development and validation are similar.

Antibody Purification Process Development and Manufacturing

December 01, 2019

Downstream process development and manufacturing play a crucial role to ensure safety, quality, identity, purity, and efficacy.