Accelerate yourbioprocess journeyGE Healthcare | BioProcess International East | Booth #305Reimagine productivity and flexibility in an interactive manufacturing environment and see for yourself how quickly we can address your capacity needs.

This immersive digital experience will allow you to discover elements of an integrated platform that delivers improved efficiency for a manufacturing line or an entire facility at a fraction of the time and cost.

Join us during our complimentary workshops and poster presentationsPresentations:Advanced control strategies in bioprocessing and biomanufacturing: disruptive technologies and emerging platforms for biologics facilities of the future

Mon. Sept. 25 | 9 am | Part of the preconference symposiaBy: Bill Whitford, Strategic Solutions Leader, Cell Culture, Bioprocess, GE Healthcare

Advances in bioprocess monitoring and analytics, as well as in bioinformatics and computational biology, are changing the way we look at the bioproduction process. Heightened computing power and connectivity, automation, and robotics are enabling this revolution. New in-line (single-use) probes and automated at-line (cell and cell-free) sampling, feeding such high-throughput analytics as NIR and SPR, are producing a lake of data to be processed. But, it is the ultra-fast microprocessors, cheap and flexible data storage, as well as advanced interfacing, process analytics, and control algorithms that determine a quantum leap in manufacturing capability. Adaptive fuzzy expert systems now employ artificial intelligence and cloud hosting to provide a continuous optimization of process performance, using previously developed models and performance data from the current as well as from previous runs.

Evaluation of next-generation protein A chromatography resin for the purification of monoclonal antibodies

Thur. Sept. 28 | Noon | Recover and purification trackBy: Bryan Dransart, Senior Research Scientist, Gilead Biosciences

Next-generation, high-capacity alkali-stable protein A chromatography resins have recently become available in anticipation of increased production and throughput demand for protein therapeutic processes. For over a decade, agarose-based, alkali-stable protein A resins have become the backbone of many commercial processes as the primary capture step for monoclonal antibody purification processes. However, the relatively high raw material costs of these resins, along with limitations to binding capacity and requirements for aggressive resin stripping strategies, still result in a high contribution to overall manufacturing cost of goods. To address these concerns, a novel higher-capacity protein A resin was evaluated using a CHO cell-expressed mAb. Stability and performance of the resin over its usable lifetime were studied by monitoring dynamic binding capacity, residual host cell protein, host cell DNA, protein A ligand leachate, and total protein carryover. Scalable conditions for column operations and sanitization that take advantage of high resin capacity and caustic stability, while maintaining the resin functionality and reuse, were identified.

gelifesciences.comGE, the GE Monogram, ÄKTA, and Xcellerex are trademarks of General Electric Company.© 2017 General Electric Company.GE Healthcare Bio-Sciences AB, Björkgatan 30, 751 84 Uppsala, Sweden.

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Battle of the BioTech Bands!LifeSize was formed in 2009 as entertainment at the, back then, annual GE Healthcare Life Sciences kickoff meeting. The six-member band is composed of professional staff employed at GE Healthcare. The group’s passion for music has kept LifeSize together and playing despite its members being located throughout the New Jersey, Boston, Maryland, and Chicago areas.

Most recently, the group headlined at the 2016 grand opening of the new GE Healthcare Life Sciences North American headquarters in Marlborough, MA. In addition, LifeSize has recorded several songs and had original music featured as part of GE Healthcare’s “Ready to Rock” BioProcess campaign in 2012. The band has also performed in 2011 at the nationwide Fortune Magazine Corporate Battle of the Bands at the Rock & Roll Hall of Fame in Cleveland.

This is the band’s first appearance at the Battle of the Biotech Bands.

Battle of the Biotech Bands is a charitable event part of BioTech Week Boston and sponsored by KNECT365. Through the generous support of GE, the band has chosen to support the Michael J Fox Foundation for Parkinson’s Research as several band members’ family members have been stricken with the disease.

Technology workshops:Cell culture perfusion doesn’t need to be complicated

Tues. Sept. 26 | 11:50 amBy: Yasser Kehail, Global Bioprocessing and Analytics Product Manager, GE Healthcare

The demand for drugs and biosimilars is growing. The need to produce high concentrations of approved biotherapeutics in smaller and more flexible facilities has driven the development of increasingly sophisticated perfusion technologies. Furthermore, the advent of single-use products has accelerated production, minimized the risk of contamination, and requires less capital investment than traditional fed-batch culture. This technical workshop will discuss the challenges of developing and evaluating a perfusion process, and demonstrates how it can be successfully utilized as part of a single-use bioreactor system.

The critical role of automation in CAR T cell manufacturing

Tues. Sept. 26 | 11:50 amBy: Rodney L. Rietze, Process Innovation and Strategic Development, Novartis

Automating the manufacturing process of a cell-based therapy is not a one-time event. Rather, it is a step-by-step, highly strategic process that is guided by a deep understanding of critical process parameters and the critical quality attributes of the resulting drug product. As understanding (and confidence in efficacy) evolves through positive clinical testing, so does confidence in receiving a positive return on investment. This presentation will describe the rationale and supporting data that guided the strategic automation of the CTL019 manufacturing process and associated analytics.

Outsourcing process development in the bid to bring rare therapies to clinic faster

Wed. Sept. 27 | 12:05 pmBy: Alex Tracy PhD, VP of Pharmaceutical Development and Manufacturing, Roivant Sciences Inc.

Roivant Sciences Inc. is currently finishing preclinical studies in recombinant human acid ceramidase (rhAC)—an enzyme replacement therapy for patients with Farber disease. This presentation will demonstrate the collaboration with GE’s Fast Trak services team, where expertise, transparency, and tech transfer were put into best practice. We will share development data and decision-making points during four stages of the project; clone selection, process development, scale-up, and cGMP production.

Addressing the risk of bioburden and the need for increased productivity in protein A chromatography

Thur. Sept. 28 | 7:30 amBy: Jonathan Royce, Senior Product Manager, GE Healthcare

Historically, the alkali-stability of protein A chromatography resins has lagged behind other resins used in downstream purification of antibody therapeutics. This fact, combined with the high nutrient load to which protein A resins are exposed, introduces a larger risk of column contamination when compared with secondary and tertiary chromatographic operations. In this presentation, we present a newly designed protein A resin, which offers alkali-stability on par with ion exchange and hydrophobic interaction chromatography resins. Data on binding capacity, caustic stability, and resin cleanability will be presented.

Thirty years of mAbs and protein A: a retrospective look at 30 years of synergies

Thur. Sept. 28 | 9:50 amBy: Geoff Hale, Managing Director, Bioarchitech

Thirty years ago, monoclonal antibodies were mainly research projects that were barely represented in pharmaceutical sales. Today, mAbs represent 50% of all biological sales and the pipeline of future mAbs and other antibody constructs is rich. Dr. Hale, who was involved in the development of one of the first mAbs, Campath, will look back on the dramatic success of our industry and how the developments of antibody and protein A technologies have followed a synergistic path to bring the industry to its current state.

Technical posters:A next-generation protein A resin for improved productivity and bioburden control

Characterization of Xcellerex™ single-use bioreactor systems

Development of a perfusion process with automated control of the biomass

Evaluation of ÄKTA™ readyflux for ultrafiltration to high protein concentration

From left to right: Matt Szap (bass and vocals), Brad Hales (vocals), Damien McCann (drums and vocals), Dan Collins (percussion and rhythm guitar), Adam Kaletski (rhythm guitar, keys, harmonica and vocals), and Phil Daravingas (lead guitar).