Development

Feliza Mirasol is the science editor for 

Articles

Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.

Using Process Modeling to Troubleshoot a Bioprocess

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

Rigenerand Develops 3D Bioreactor for Extracellular Vesicle Exosomes Production

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

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

Eliminating Residual Impurities Starts with a Strategic Plan

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

Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data Analytics

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

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

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

Ensuring Smooth Tech Transfer of Bioprocess Operations

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

Orgenesis, ExcellaBio Announce Breakthrough Manufacturing Process for Bioxomes

Agnes Shanley is senior editor of Pharmaceutical Technology.

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


Improving Upstream Predictability

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

The Need for Advanced Process Modeling for New Therapeutic Biologics

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

Process Development