Downstream Processing

Tareq Jaber, tareq.jaber@crl.com, is associate director at Charles River Laboratories.

Anja Tessarz, Anja.Tessarz@crl.com, is associate director RGDB, SME Viral Clearance at Charles River Laboratories.

Articles

The design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.

Viral Clearance Studies: Challenges and Beyond

Editor of Pharmaceutical Technology Europe

Thanks to technological advances, process chromatography challenges are surmountable, but increasingly complex therapies in the pipeline will demand more efficient processes in the future.

Advancing Process Chromatography in DSP 

An increasingly complex development pipeline and industry considerations, such as sustainability, are leading to a greater need for more efficient separation and purification in downstream processing.

Driving Efficiencies in DSP Separation and Purification

Grant Playter is the Assistant Editor for 

The past year of downstream processing has brought innovations in pH sensitive antibody purification, single-use fermentation separators, and more.

What’s New in Downstream Processing?

Jennifer Markarian is manufacturing editor of BioPharm International.

Flexible and efficient methods are needed for biopharmaceutical manufacturing. 

Demonstrating a Fully Continuous Bioprocess

Emerging drug classes are giving rise to challenges in downstream processing, pushing the need for strategizing efficiencies.

Considering Purification and Separation in the Downstream Train

Feliza Mirasol is the science editor for 

Enhancement of resin technology can improve the ability of chromatography to purify the growing landscape of increasingly complex biomolecules.

Enhancing Resins Addresses Purification Concerns

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

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.

Manufacturing, Separation and Purification