Downstream Processing

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

Articles

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

Feliza Mirasol is the science editor for 

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

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

Innovative Chromatography Resins Can Improve Purity and Quality

Sartorius has expanded in the United Kingdom with the relocation to a new facility in Havant, Hampshire, for downstream processing equipment.

Sartorius Opens New Downstream Center of Excellence Facility in UK

Sherri Dolan is a global technology consultant for Virus Clearance at Sartorius North America.

Paul Nolan is a process scientist at Sartorius in Glasgow, Scotland.

Stephen Carey is an analyst at Sartorius in Glasgow, Scotland.

Craig Quinney is a process scientist at Sartorius in Glasgow, Scotland.

Lorna Littlejohn, lorna.littlejohn@sartorius.com, is the manager of Confidence Virus Clearance Services at Sartorius in Glasgow, Scotland.

A series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.

Using Anion Exchange Membrane Adsorbers to Ensure Effective Virus Clearance of Challenging Parvoviruses

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

Establishing an automated inline dilution system can potentially ease bottlenecking delays resulting from higher upstream yields.

Using Automated Inline Dilution to Ease Bottlenecking

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

Manufacturing, Separation and Purification