Viral clearance must evolve along with newer biotherapeutic modalities.

New Modalities, New Viral Clearance Challenges

A purification process simplifies downstream processing for biologics.

Disruptive mAb Purification 

A unified scale-up approach can be applied to any unit operation.

Scaling Bioprocess Unit Operations

Topic

Garima Thakur is a graduate student in the Department of Chemical Engineering at the Indian Institute of Technology New Delhi.

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi and a member of 

l's Editorial Advisory Board, Tel. +91.9650770650, asrathore@biotechcmz.com.

Articles

The need for real-time monitoring and control has spurred the development of new analytical tools.

Near Infrared Spectroscopy as a Versatile PAT Tool for Continuous Downstream Bioprocessing

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

Feliza Mirasol is the science editor for 

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

Meeting Fill/Finish Challenges for COVID-19 Vaccines

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

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

Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.

Updating Viral Clearance for New Biologic Modalities

Kilian Brand is lab technician downstream process development at 

Florian Capito is lab head downstream process development 

Verena Oeinck is lab technician downstream process development at 

Hendrik Flato is lab engineer downstream process development at Sanofi-Aventis Deutschland GmbH.

Marc Bisschops is director at Pall Medistad.

Martin Glenz is principal scientist at Pall GmbH.

Ralf Ehret is vice dean at Provadis School of International Management and Technology.

Continuous SEC was shown to increase productivity with the same product quality and yield.

Continuous Preparative SEC for Purification of “Difficult-to-Manufacture” Proteins–A Feasibility Study

The latest advances in downstream technologies include sterile disconnects for single-use manufacturing systems, ligand technologies for purifying RNA and for COVID-19 vaccines, and an automated perfusion system.

What’s New in Downstream Technologies 

Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.

Rentschler to Partner with BioNTech for COVID-19 Vaccine Manufacturing 

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

A balance must be achieved between debris and impurity removal and maximizing product quality and yield.

Downstream Processing

New Modalities, New Viral Clearance Challenges

Disruptive mAb Purification

Scaling Bioprocess Unit Operations