Topic

Swapan Kumar Jana is director, R & D and Production, PPCV at Serum Institute of India Pvt Ltd, skjana@seruminstitute.com.

Amol Dattatraya Mahajan is manager, R & D and Production, PPCV at Serum Institute of India Pvt Ltd.

Vishal Vijayan is MSAT specialist at Merck Life Science Pvt Ltd, India.

Praveen Kumar Ravichandran is MSAT specialist at Merck Life Science Pvt Ltd, India.

Subhasis Banerjee is technical consultant at Merck Life Science Pvt Ltd, India.

Sourabh Kumar is manager, MSAT, at Merck Life Science Pvt Ltd, India.

Articles

This research focuses on refining the clarification step by assessing the performance of various depth filters. The study explores both conventional cellulose-based and innovative synthetic depth filters, utilizing pneumococcal fermentation harvests from two challenging serotypes.

Optimization of Clarification Step in Pneumococcal Polysaccharide Conjugate Vaccine Manufacturing: Evaluating the Performance of Depth Filters

Stijn H. S. Koshari is a principal investigator at Downstream Process Development, BioPharma R&D, GlaxoSmithKline, King of Prussia, Pennsylvania 19406.

Hong Zhang is an investigator at Downstream Process Development, BioPharma R&D, GlaxoSmithKline, King of Prussia, Pennsylvania 19406.

Antonio Ubiera is a senior director at Downstream Process Development, BioPharma R&D, GlaxoSmithKline, King of Prussia, Pennsylvania 19406.

Robert G. Luo is a scientific director, at Downstream Process Development, BioPharma R&D, GlaxoSmithKline, King of Prussia, Pennsylvania 19406.

The authors evaluated the potential of direct filtration for multiple biopharmaceutical candidates. This article is Part 2 of the study.

Fouling Mechanisms of Filters During the Harvest Development of Monoclonal Antibody Therapeutics with Intensified Upstream Processes—Part 2

The authors present a methodology to assess the contribution of individual filters to overall capacity of the direct filtration train, and elucidate how capacity is affected by characteristics of the cell culture broth and process parameters, including for enhanced upstream processes such as those incorporating high cell density perfusion. 

Fouling Mechanisms of Filters During the Harvest Development of Monoclonal Antibody Therapeutics with Intensified Upstream Processes—Part 1

William Tran is a senior scientist at Biologics Process R&D, Merck and Co. (MSD outside of the United States and Canada).

Jack Bowers is a senior principal scientist at Biologics Process R&D, Merck and Co. (MSD outside of the United States and Canada).

T. Craig Seamans is a senior principal scientist at Biologics Process R&D, Merck and Co. (MSD outside of the United States and Canada).

Helena Öhrvik is senior product manager at In Silico Process Development, Cytiva.

Andreas Castan is strategic technology leader at In Silico Process Development, Cytiva.

The authors give an overview of scaling approaches and present good scaling practices for the biopharma industry.

Right the First Time: Bioreactor Scale and Design Translation

Ajay Babu Pazhayattil, DBA, M.Pharm, ajpazha@gmail.com, is a pharmaceutical management consultant for cGMP World

Gyongyi Konyu-Fogel, DBA, D.Ed., gyongyi.konyu-fogel@faculty.umgc.edu, is a graduate professor of business, at the University of Maryland Global Campus.

A survey was conducted to examine the adoption of machine learning and artificial intelligence in the bio/pharma manufacturing industry.

ML and AI Implementation Insights for Bio/Pharma Manufacturing

Kevin Hutter is investigator, Process Engineering and Analytics, Drug Product Development, GSK.

Kashappa Goud Desai is scientific leader, Process Engineering and Analytics, Drug Product Development, GSK.

Igor Rusanov is principal investigator, Process Engineering and Analytics, Drug Product Development, GSK.

Aarti Gidh is director, Process Engineering and Analytics, Drug Product Development, GSK.

Use of a small-scale filler can result in increased filling efficiency.

Small-Scale Syringe and Vial-Filling Capability for Development of Robust Filling Processes, Smooth Tech Transfers, and to Resolve Manufacturing Issues: Summary of Key Learnings

Lucrèce Nicoud, lucrece.nicoud@ypso-facto.com, is head of product at Ypso-Facto, France.

Yohann Le Guennec is project manager at Ypso-Facto, France.

Edouard Nicoud is head of customer success at Ypso-Facto, France.

Antonio Cardillo, PhD, is expert scientist & GSK fellow at GSK, Italy.

Elena Lietta, PhD, is from Politecnico di Torino, Duca degli Abruzzi, Italy.

Elisa Innocenti is scientist at GSK, Italy.

Alessandro Pieri, PhD, is scientific leader & GSK associate fellow at GSK, Italy

In this article, a simple chromatographic model is proposed that is capable of predicting the impact of pH and ionic strength on HIC chromatograms.

Purification of Protein by HIC: Mechanistic Modeling for Improved Understanding and Process Optimization

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.

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.

Peer-Reviewed Research