Automation streamlines cell harvest workflow and minimizes contamination.

Automated Processes Benefit Cell Harvesting

New biologic modalities pose difficulties for viral clearance testing methods.

Modalities Challenge Viral Clearance Testing

Understanding process goals is the first step to effective process development.

A Holistic Approach to Purification

Topic

Feliza Mirasol is the science editor for 

Articles

Confounding signals pose challenges to analytical methods necessary for managing residual impurity removal in biotherapeutic manufacturing.

Managing Residual Impurities in Complex Biotherapeutics

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

Surrogate analytics are no longer sufficient, as simple inexpensive real-time analytics are urgently needed for high value products.

Analytics Advances for Optimizing Downstream Processes 

Editor of Pharmaceutical Technology Europe

Process chromatography in downstream processing has seen steady improvements over the years, but there is still room for improvement.

Process Chromatography Makes Steady Progress 

Jennifer Markarian is manufacturing editor of BioPharm International.

Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.

Using Digital Twins to Model Process Chromatography

Automation is one asset that benefits cell harvesting by cutting out laborious manual steps and minimizing contamination.

Cell Harvesting Sees Benefits from Automated Processes

Understanding the process and product goals is just the first step to a holistic approach to process development.

Defining a Holistic Approach to mAb Purification Processes

New biologic modalities, such as cell and gene therapies, pose increasing difficulties in viral clearance testing methods.

Viral Clearance Testing Increasingly Challenged by New Biologic Modalities

Mark Rogers, PhD, mark.rogers@sgs.com, is the global scientific director for the SGS Health Science Drug Development group. He  has been with SGS for nearly 8 years since joining the company via an acquisition (M-Scan) in 2010. Rogers received his PhD in analytical chemistry from Westminster University in 1985 and has over 35 peer-reviewed publications, including Nature, and one patent. His post-doctoral work, at Imperial College, London, was followed by a lectureship in the endocrinology department at St. Mary’s hospital specializing in diabetes. Rogers then went on to join M-Scan, USA in 1990 where he remained as vice-president until its acquisition by SGS. Since joining SGS he has had several roles including, head of North American Biologics, vice-president of SGS USA, and today, he is the Global Scientific director for the SGS Health Science Drug Development group.

New challenges in extractable and leachable studies for cell and gene therapy products.

Preparing for the Unexpected: E&L Studies in Biopharma

GoSilico’s software for digital twins of downstream biopharmaceutical processes will be integrated into Cytiva.

Cytiva Acquires German Software Maker GoSilico 

Recent innovations in chromatography resins offer promising advantage in downstream bioprocessing.

Downstream Processing

Automated Processes Benefit Cell Harvesting

Modalities Challenge Viral Clearance Testing

A Holistic Approach to Purification