An Investigation into Integration of Disposable Components into Traditional Stainless-steel Facilities


22nd May 2018 | 10AM EST | Ron Bates, Bristol-Myers Squibb and Miriam Monge, Sartorius Stedim biotech Integrated Solutions |WATCH FOR FREE

This presentation will analyse the benefits and limitations associated with the implementation of single-use technology at a large-scale, multi-product commercial manufacturing facility. By integrating single-use components into a stainless steel facility, a hybrid equipment approach enhances manufacturing flexibility while enabling an accelerated manufacturing cadence.

 

Presented by Ron Bates, Bristol-Myers Squibb

I lead the Manufacturing Science and Technology (MST) group at Bristol-Myers Squibb (BMS) in Syracuse, NY and am responsible for monitoring, validating, transferring, and improving late-stage and commercial manufacturing processes. Prior to BMS, I led the process development and MST group at Allergan focusing on developing, optimizing, characterizing, transferring, and support manufacturing of wild-type and recombinant prokaryotic-based systems to manufacturing. At Allergan, we developed high throughput methods and implemented disposable processing. Prior to Allergan, I worked at BMS-Syracuse developing and transferring downstream processes to manufacturing for late-stage Fc-fusion and monoclonal antibodies. Before BMS, I worked at Pfizer purifying small molecule moieties using chiral, normal phase, and reversed phase chromatography in traditional, flash, and multi-column continuous systems.  I received my Ph.D. from the University of Maryland, Baltimore County in Biochemical Engineering under Doug Frey studying mathematical modeling of ion exchange chromatography and my B.S. in Chemical Engineering from Rensselaer Polytechnic Institute.

 

Sponsored by Sartorius Stedim Biotech

 

Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions are supporting biopharma companies around the world to develop and produce drugs safely, timely and economically. To meet the rapidly changing technology requirements of the industry it serves, Sartorius Stedim Biotech focuses on single-use technologies and value-added services.

 

 

Presented by Miriam Monge, Director of Marketing (BA, MBI, MBA) Sartorius Stedim biotech Integrated Solutions

Miriam is best known in the industry for her contribution during the pioneering phase of Single-use disposable technologies as Marketing Director for Stedim Biosystems. Miriam founded and chaired the ISPE global disposables community of practice in 2008 aimed both at promoting education and evaluating the global regulatory requirements for single-use disposable technologies as the industry matures . Miriam co-authored a regular column ‘ the disposables advisor’ for several years in Biopharm International , is a Senior visiting lecturer at University college London department of biochemical

engineering and an editorial advisor for Bioprocess International. Miriam’s current position at Sartorius Stedim biotech focuses on building a global process development team combined with developing full bioprocess platform offerings based on disposable & hybrid technologies for MAbs, viral vectors/ Vaccines, ADC’s, intensified/ continuous processing with related services from PD to CGMP commercial scale. Prior to joining Sartorius Miriam spent 6 years as a Principle consultant at Biopharm Services where her focus was on how processes can be optimised in early phase development through

bioprocess modelling of technology & process design options enabling highest throughput & lowest Cost of Goods. During this time Miriam also acted as a subject matter expert and internal consultant on single-use strategy & implementation for major biopharma’s such as Sanofi , and contract manufacturers such as BI and CMC biologics.


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