Development

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

Articles

Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming.

Remote Monitoring and Big Data Advance Upstream Automation

The new facility, to be located in Boston, MA, will contain experimental and analytical equipment for viral vector and advanced therapy process development and will expand the CDMO’s manufacturing capacity.

Fujifilm Corporation to Invest $40 Million into New Viral Vector and Advanced Therapy Facility

Feliza Mirasol is the science editor for 

Cell-culture optimization may see benefits from a synthetic biology-based approach that improves product titer, quality, and time.

Cultivating a Synthetic Biology-Based Approach to Improving Cell Culture

Thomas Prouzeau is a purification process development scientist at Sanofi.

Jerome Pezzini, Jerome.pezzini@sanofi.com, is purification process and technology leader at Sanofi.

Benoit Mothes is purification process development group head at Sanofi.

The development of an innovative purification process simplifies downstream processing for biologics.



EASY: a Disruptive mAb Purification Process to Reduce Cost of Goods

Agnes Shanley is senior editor of Pharmaceutical Technology.

More collaboration and a knowledge-based approach, driven by better analytics and high-throughput system integration, are reducing the risk of failure.

Pinpointing Bioprocess Development Success

Toshihiko Otsubo is principal scientist of Biologics Process Development, 

Pharmaceutical Sciences, Takeda Pharmaceutical.

Shinji Tsuji is associate director at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Yoshiaki Miko is Associate Director of Biologics & New Modalities Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Tetsuya Moritake is associate director of Project Leadership & Operations, 

Pharmaceutical Sciences at Takeda Pharmaceutical.

director and head of Manufacturing Operations of Biogics Process Development

The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.

Proposing a New Method of Detecting Pinholes in Single-Use 

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

SBIR Awards $1.4-Million Grant to Accelerate Antibody Manufacturing Technology 

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

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

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.

Mapping a Route for Cell and Gene Therapy Process Development

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

Antibody Purification Process Development and Manufacturing

In batch production, efficient exception management means reducing the time required to identify, review, and resolve process exceptions. Incorporating review by exception functionality within manufacturing execution system (MES) software can streamline biopharmaceutical product release.


Review by Exception: Connecting the Dots for Faster Batch Release

Agnes Shanley is senior editor of BioPharm International.

Bob Lenich, Emerson's business director for global life sciences, shares insights on where biopharma modeling is now, and where it is heading in the near future.
