Topic

Chaz Goodwine is lead downstream scientist at AGC Biologics.

Katrin Töppner, Katrin.Toeppner@Sartorius.com, is Product Development (PD) scientist at Sartorius Stedim Biotech.

Patrick Adametz, Patrick.Adametz@Sartorius.com, is process engineer at Sartorius Stedim Biotech.

Ricarda A. Busse is product manager for Membrane Chromatography Consumables at Sartorius Stedim Biotech.

Volkmar Thom is head of PD Purification Materials at Sartorius Stedim Biotech.

Articles

In part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.

Purification of Antibodies Using Novel Convecdiff Membranes Part 2: Robust Performance at Comparable Product Quality

The testing of new convecdiff membranes shows this material to be well suited for lab- and commercial-scale bind-and-elute applications.

Purification of Antibodies Using Novel Convecdiff Membranes Part 1: Providing High Binding Capacity at Short Residence Time and Low Pressure Drops

Matthew Sanders is vice-president, head of Global Drug Substance at GSK, Rixensart, Belgium.

Roland Mainil is director, Technical Development Lead at GSK, Rixensart, Belgium.

Wael Chahim is associate director, Development Unit Head at GSK, Rixensart, Belgium.

Using a minimum valuable product and process approach would make it is possible to discipline and structure the development of biopharmaceuticals in the fastest way possible.

Introducing a New Concept for Value-Driven Acceleration in Biopharma Development

Sílvia Helena Cestari de Oliveira is researcher in the biotechnology division at Cristália Produtos Químicos Farmacêuticos, Itapira, Brazil.

Marcos Castanheira Alegria is R&D director at Hypera Pharma.

Marco Antonio Stephano is professor at the University of Sao Paulo, Sao Paulo, Brazil.

This article introduces the requirements for a biosimilar license in Brazil and addresses questions about their quality, safety, and efficacy.

Brazilian Regulation of Biosimilar Products: What Is Important to Know

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.

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.

Peer-Reviewed Research