Topic

Mili Pathak is principal scientist, Process Science, R&D, at Intas Pharmaceuticals Ltd. (Biopharma Division), Ahmedabad, Gujarat, India.

Prashant Pokhriyal is associate scientist at Intas Pharmaceuticals Ltd. (Biopharma Division), Ahmedabad, Gujarat, India.

Ronak Patel is principal scientist, R&D, at Intas Pharmaceuticals (Biopharma Division), Ahmedabad, Gujarat, India.

Laxmi Adhikary, PhD, is senior vice-president, R&D, at Intas Pharmaceuticals (Biopharma Division), Ahmedabad, Gujarat, India.

Articles

The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.

Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?

Joana S. Cristóvão, PhD, jscristovao@hovione.com, is an analytical scientist at Hovione Farmaciência S.A., R&D, Analytical Development.

Salomé Neto was a Master’s student at Hovione Farmaciência S.A., R&D, Analytical Development.

Establishing analytical workflows for complex biopharmaceutical molecules can help predict their risk of degradation.

Conformational and Colloidal Stability Studies to Predict the Best Biopharmaceutical Formulation

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

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

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

Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.

Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data Analytics

This study aims to use plant-leaf extract for the green synthesis of gold nanoparticles and to evaluate their antibacterial and antioxidant activity.

Therapeutic Potential of Green, Synthesized Gold Nanoparticles

In this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.

Catalytic Site Analysis and Characterization of a Solvent-Tolerant Aldo-Keto Reductase

Harry Silver is senior process/facility designer at Harry Silver Designs.

Mark Witcher is a consultant, witchermf@aol.com

The authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.

Comparing Facility Layout Options for Managing Business and Operating Risks

Karen Chan is a staff engineer at MilliporeSigma.

Torsten Bisschop is a biomanufacturing engineer consultant at MilliporeSigma.

Herb Lutz is a principal consultant at MilliporeSigma.

A key technology that can help achieve a continuous production flow is single-pass tangential flow filtration.

Peer-Reviewed Research