At Repligen bioprocessing seminars, thought leaders and professionals from around the world meet and review exciting new drivers of bioprocessing efficiency, learn from adopters of transformative technologies, evaluate risk landscapes and collaborate to help set the standards for modern bioproduction. 

Agenda

To view speaker biographies and session abstracts,
click Expand All or the + next to each title.

Registration will begin at 9:00 a.m. Pre-registration is required to attend.

Abstract

Continuous integrated manufacturing of mAbs is a new paradigm that is being considered not only to decrease capital and operating costs but mainly to improve product quality and facilitate regulatory issues. With reference to a specific commercial mAb, we analyze a few steady state runs where all steps (perfusion, capture and polishing) are integrated and operated as a single unit. The use of simulation models to keep the various units within specifications while reducing production costs is discussed. Additionally, it is shown that continuous process polishing with the MCSGP technology overcomes the purity-yield tradeoff of classical batch chromatography. These aspects contribute to make integrated continuous manufacturing more efficient in terms of productivity, yield and product quality than the current batch technologies. This conclusion is discussed quantitatively by comparing product quality in continuous integrated and classical batch production units.

Speaker Bio

massimo.jpg

Dr. Massimo Morbidelli is currently currently Professor of Chemical Reaction Engineering at the Institute for Chemical and Bioengineering at ETH Zurich (Switzerland). He serves as an Associate Editor of the ACS journal of Industrial & Engineering Chemistry Research, and is the recipient of the 2005 R.H. Wilhelm Award in Chemical Reaction Engineering of the American Institute of Chemical Engineers, of the 2014 Gerhard Damköhler-Medaille of DECHEMA.and VDI-GVC and of the 2017 Excellence in Process Development Research Award by the Process Development Division of the American Institute of Chemical Engineers. He is a cofounder of ChromaCon Ltd., a spin-off company from his research group.  He is co-author of more than 600 papers, 11 international patents and four books. Dr. Morbidelli received his Laurea in Chemical Engineering at the Politecnico di Milano and PhD at the University of Notre Dame.

Abstract

Implementation of single-use alternatives in tangential flow filtration (TFF), a critical step in concentration and diafiltration (buffer exchange), is becoming platform in downstream bioprocessing. Repligen TangenX™ SIUS™ Single-use Cassettes are the first purpose-built cassettes designed for tangential flow filtration. This presentation will demonstrate how deploying these innovative cassettes can help reduce filter cost by 80%, reduce labor costs by 50%, and reduce buffer and water usage by 75% when compared to traditional reusable cassettes.

Speaker Bio

Mike LaBreck.jpgMichael LaBreck is Director for Repligen TangenX™ TFF products at Repligen starting in December 2016.  Before that, he supported the TangenX™ product line at NovaSep 2008- 2016. He has over 20 years experience with tangential flow filtration applications support in the biopharmaceutical industry.  He has held various sales and applications engineering positions with Pall Corporation and GE Healthcare. Michael has a Bachelor of Science degree in Mechanical Engineering from Syracuse University. 

   

Abstract

Now with an innovative side port that allows for simple resin unpacking, OPUS® 45R and OPUS® 60R columns provide the ultimate flexibility in pre-packed column technology. Without compromising chromatographic performance or column cleanability, the new feature helps mitigate the risk of implementing pre-packed columns in cGMP settings, and allows for re-use of the unpacked resin for other purposes. Test results on chromatographic performance, bioburden testing, shipping tests and simple unpacking procedure will be presented along with an overview of our entire OPUS® product portfolio, including  our Process Development columns (0.5-5cm ID) that are designed for use in every step during downstream process development, including screening, process validation including viral clearance, scale-up and sample preparation. OPUS® large scale columns are available in formats ranging from 10-60 cm ID.

Speaker Bio

fletcher malcolm headshot - princeton seminar.jpgFletcher Malcom is a creative MBA graduate and biopharmaceutical industry professional, who spent his early career with Waters Corporation as a technical chromatography representative working with large pharmaceutical and biotechnology clients in the Eastern United States.  Since leaving Waters, Fletcher has graduated with honors from Babson’s MBA program, and joined Repligen as a Product and Marketing Manager.   In 2011 & 2012 Fletcher led all efforts to complete the development and commercialization of Repligen’s new platform of OPUS® pre-packed disposable columns.  Currently, Fletcher is the Director of Product Management for Repligen's Downstream Technologies.  

Abstract

Merck is following the global trend of continuous manufacturing. To support perfusion cell culture development, small-scale semi-continuous screening methods were developed. These methods were applied on a set of different clones and compared to real continuous conditions (lab-scale bioreactors). Growth and productivity performance were compared and helped to define a ranking strategy for screening application, specific to perfusion.

Speaker Bio

jean-marc-bielser.jpgJean-Marc Bielser is currently in the PhD program within Merck and in collaboration with the Morbidelli group from ETH in Zürich. Jean-Marc first joined Merck in 2012 as Scientist in the Cell Culture group. He has worked on many upstream projects using different cultivation systems ranging from microliters to 50L pilot scale bioreactors. The projects he was involved with include clone screening, media optimization, and development of the perfusion technology. Jean-Marc received his MSc in Chemical Engineering and Biotechnology at EPFL in 2012 after an industrial internship in Basel and a Master thesis at MIT in Cambridge, MA (USA).

   

Abstract

Fujifilm Diosynth Biotechnologies (FDB) are a world leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting the biopharmaceutical industry with the development and production of therapeutic candidates. For multi-product facilities like FDB, single use (SU) or single campaign technologies can offer significant benefits - this talk will focus on how and why FDB has implemented pre-packed columns (PPC) in their entirely SU Mammalian Cell Culture manufacturing facility in the UK and how FDB is now deploying pre-packed technologies for some of their microbial fermentation facilities. An overview will also be given about how FDB intends on using PPC at every scale of R&D and GMP manufacture in their exciting new mAb-platform offering, Saturn.

Speaker Bio

Dr. James Pullen is currently the Subject Matter Expert in Chromatography at Fujifilm Diosynth Biotechnologies (FDB) in the UK. He is responsible for functional, operational and technical chromatography-related aspects within R&D. He also provides consultation and technical support of customer projects across the wider business at all stages of a program journey, from high-throughput scale-down through to commercial manufacture. Dr. Pullen’s previous roles at FDB have included Technical Project Leader and Principal DSP Scientist. Prior to his industry roles, Dr. Pullen held post-doctoral research positions related to protein biochemistry and biophysics at Leeds and York Universities. Dr. Pullen has an MSci in Chemistry and a PhD in Biological Chemistry from Imperial College, London.

Light refreshments will be served.

There is no charge for attendance but registration is required. Seats are limited to end-users of bioprocessing tools and technologies.

Travel, accommodations, and incidental expenses are the responsibility of attendees. Lunch will be served.

Courtyard by Marriott Basel

Moench-Jungfrau Room
Hardstrasse 55
CH- 4133 Pratteln

Register today!

Questions?

Contact events@repligen.com

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