Development

Articles

Well-defined studies are crucial to effective process development.

Common Challenges in Cross-Functional Process Development

Yan He is the senior scientist at BioSpherix, Ltd., 25 union St. Parish, NY

Shannon Darou is a technician at BioSpherix, Ltd., 25 union St. Parish, NY

Stassa P.D. Henn is an intern at BioSpherix, Ltd., 25 union St. Parish, NY

Rose Walter is an intern at BioSpherix, Ltd., 25 union St. Parish, NY

Randy Yerden is the chief executive officer at BioSpherix, Ltd., 25 union St. Parish, NY

Alicia D. Henn is the chief scientific officer, all at BioSpherix, Ltd., 25 union St. Parish, NY

Controlling certain atmospheric conditions in a closed NGI processing chamber can reduce bioburden without disinfectants. 

Temperature and Relative Humidity Control to Reduce Bioburden in a Closed Cell Processing and Production System without Disinfectants

Agnes Shanley is senior editor of Pharmaceutical Technology.

As downstream bioprocessing improvements continue, efforts are underway to integrate downstream processes into continuous operations. 

Moving Closer to End-to-End Continuous Bioprocessing

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

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

Remote Monitoring and Big Data Advance Upstream Automation

Joshua Arias, joshua.arias@milliporesigma.com, is technical leader, BioReliance End to End Solutions, MilliporeSigma.

Mani Vinay Kumar Kotipalli is process engineer, Drug Substance Technology & Engineering, Amgen.

A unified scale-up approach, as presented here, can be applied to any unit operation.

A Unified Approach for Scaling Bioprocess Unit Operations

The launch of HiScreen Fibro PrismA, the company’s newest product for early mAb purification process development strengthens Cytiva’s new fiber-based Protein A platform.

Cytiva Advances Fiber Chromatography Technology with New Launch

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

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