TAP Biosystems And Gallus Biopharmaceuticals, LLC Co-Host FREE Webinar On Accelerating Biosimilar Process Development Explaining The Benefits Of Using ambr15 Microbioreactors For DoE

Cambridge, UK: TAP Biosystems (now part of the Sartorius Stedim Biotech Group), a leading supplier of innovative cell culture and fermentation systems for life science applications, is delighted to announce that it will be co-presenting a new bioprocess webinar with major US contract manufacturing organisation (CMO) Gallus BioPharmaceuticals, on Thursday November 6th 2014 at 4pm GMT /5pm CEST / 8am PST / 11am EST. The live event will detail how Gallus is using the ambr15™ automated microbioreactor system as a tool for implementing DoE (Design of Experiments) to accelerate biosimilar process development.

Bioprocessing experts, Dr. Matt Zustiak, Principal Scientist at Gallus BioPharmaceuticals and Dr. Joanne Swihart, ambr15 Product Specialist at TAP Biosystems, will present data on how the ambr15 micro bioreactor system mimics large-scale cell culture to enable rapid process development for biosimilars. To access the free webinar, scientists can register at: http://view6.workcast.net/register?pak=7140783969312062

During the 60 minute webinar, Dr. Swihart will introduce the ambr15 system and its potential in shortening process scale-up timelines, with industry data demonstrating the consistency and scalability of ambr15 when compared to benchtop and larger scale bioreactors. Dr. Matt Zustiak will then outline Gallus’ use of the ambr15 system in their new Process Development facility for DoE as part of their QbD (Quality by Design) strategy of biosimilar development. In his presentation, Dr. Zustiak will discuss the impact of media and feeds on critical quality attributes, as well as how to identify key process parameters.

Dr. Joanne Swihart, TAP Biosystems’ ambr15 Product Specialist explained: "Using a QbD approach, CMOs can deliver biosimilars with higher yields and titres. However, implementing DoE in a QbD framework can involve running and analysing results from hundreds of process parameter combinations. For most companies this is just not feasible, and explains why high throughput process development modelling tools are critical to success.”

Dr. Swihart continued: “I’m excited to host this new webinar with Matt Zustiak in which we’ll present data showing how ambr15 offers an intelligent method for rapidly assessing a large number of parallel media and feed parameters in a DoE context. This will demonstrate how ambr15 is helping develop robust, high performance cell culture processes, ensuring Gallus’ top pharma and biotech clients can rapidly deliver cost-effective biosimilars to market.” -E

For Further Information Contact:

Michaela McAdam, Marketing Communications Manager, TAP Biosystems, York Way, Royston, Hertfordshire, SG8 5WY, UK. Tel: +44 (0) 1763 227200 Fax: +44 (0) 1763-227201 Email:Michaela.mcadam@tapbiosystems.com Web: www.tapbiosystems.com Twitter: @TAPBiosystems

Claire Ruzicka, Senior Marketing Manager, Gallus BioPharmaceuticals, LLC,4766 LaGuardia Dr.ive, St. Louis, MO 63134-3117, USA. Tel: + (314) 562-5755 Email: claire.ruzicka@gallusbiopharma.com Web: www.gallusbiopharma.com

Editor Contact:

Dr. Sue Pearson, Director, International Science Writer, PO Box 170, Hitchin, Hertfordshire, SG5 3GD, UK. Tel/Fax + 44 (0) 1462-635327 Email: sue.pearson@internationalsciencewriter.com Web: www.internationalsciencewriter.com Twitter: @Isciencewriter

Note to Editors

About TAP Biosystems

TAP Biosystems (now part of the Sartorius Stedim Biotech Group) is a leading global provider of automated cell culture and fermentation systems for life science research, development and production. TAP's systems are in use worldwide at pharmaceutical, biotechnology and academic laboratories, supporting bioprocess development and GMP manufacture of biologics and cell therapies, as well as discovery and stem cell research programmes.

Founded in 1987, the company has offices in the UK and USA, and an extensive network of distributors in Europe and Asia offering pre- and post-sales support. www.tapbiosystems.com

About Gallus BioPharmaceuticals

Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacture of Stelara® and Remicade® for Janssen Pharmaceuticals. Gallus’ facility in Princeton, New Jersey, has three decades of experience in process development and clinical manufacturing of bulk and aseptic-filling of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs, and collagens, plus over 20 years of experience of commercial manufacture including the supply of ProstaScint®. Both sites maintain exemplary quality and regulatory records.

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