Visit GE Healthcare at booth #312 to
Accelerate your bioprocess journey

March 11–14, 2019
BioProcess International West | Santa Clara Convention Center, Santa Clara, California, USA

Join GE Healthcare at BPI West

Speed and efficiency are critical elements of a biomanufacturing strategy and the right supplier can contribute to your business success. Discover how optionality minimizes capital investment risks and dramatically increases speed to market. Engage with GE to gain access to our industry expertise and insights that boost productivity, increase output, strengthen performance, and speed results.

Register today to connect with one of our experts at BPI West. We'll get in touch to confirm a time and date.

Elevate flexible biomanufacturing

Explore automated flexibility in an interactive manufacturing environment and see how quickly we can address your capacity needs.

Take the digital challenge and discover elements of an integrated platform that delivers improved efficiency for a manufacturing line or an entire facility at a fraction of the cost and time.

Sponsored presentations

Next generation biomanufacturing and facility implementation: technical advances in manufacturing technologies to improve process productivity

Tue, Mar 12   10 AM   Mission City B4

Presenter: Parrish Galliher, Chief Technology Officer, Upstream, GE Healthcare
Track: Flexible & Smart Facilities

Enabling efficient biomanufacturing with digital innovation

Tue, Mar 12   2:45 PM   Mission City B4

Presenter: Harlan S. Knapp, Business Development Manager, GE Healthcare
Track: Flexible & Smart Facilities

Constant pressures to improve productivity have led biomanufacturers to carefully examine potential benefits of Industry 4.0 and cloud-enabled data lakes. We will explore the concept of a factory that uses a combination of lean and digital manufacturing to enhance efficiency. See how digital solutions such as Lab Cloud, Digital Twin, and Asset Performance Management are deployed to enable the next generation of drug development and flexible manufacturing.
Harlan Knapp is Business Development Manager for Upstream & Digital at GE Life Sciences, aligning strategy and resources to implement robust upstream processes integrated into the Industrial Internet (IIoT). Harlan has been with GE for over 5 years as an Account Manager and Downstream Specialist. Prior to GE, he held roles as a Bioprocess Sales Engineer and Manager of Systems Integration & Automation. He received his Master’s in Biology from Eastern Washington University.

Cellulose fiber protein A adsorbent is paving the way for the future of mAb purification

Tue, Mar 12   2:15 PM   Mission City B5

Presenter: Jerome Pezzini, Scientist, DSP Breakthrough Skill Center, Sanofi
Track: Late Stage

Fibro chromatography based on cellulose fiber protein A adsorbent is a new technology for antibody purification enabling unprecedented productivity and flexibility through rapid cycling of the capture step. This plug and play solution provides a single-use operation at much faster flow rate than conventional packed bed columns, with similar binding capacity and purification efficiency. This Sanofi case study at lab and pilot scale will help to demonstrate how the future of purification will benefit from such technology.
Jerome Pezzini is a principal Scientist at Sanofi working in the DSP Breakthrough technology skill center who helps to drive innovation and new technology assessment in the field of purification of biologics. Jerome has previously worked in process development and held various positions within the biopharmaceutical industry since completing his doctorate in biochemistry.

Lunch ‘n’ Learn presentation

Adopting BPOG supply chain best practices—case studies and lessons learned

Wed, Mar 13    Noon    Mission City B4


GE Healthcare Life Sciences and Sealed Air Corporation will discuss how they incorporated the tenets and disciplines, in the BPOG publication “Supply Chain Mapping a Best Practice for the Biopharma Industry”, into a multi-resin bioprocessing film. The collaborative project was highly complex as it contained several layers of sub-suppliers. Benefits from these actions will be shared along with case studies showing how mapping the supply chain highlighted the need for appropriately placed controls to better manage identified risks. GE will also present the expansion and activation of a security of supply business function within the single-use bioprocess business.

Ross Acucena, General Manager, Single-use Consumables, GE Healthcare

Nicholas Berendt, Director of Global Medical Market Development, Sealed Air Corporation

Niklas Signer, Upstream Security of Supply program leader, GE Healthcare

Technology workshop

A pragmatic approach to layout and automation when designing a new biomanufacturing facility

Wed, Mar 13    11:30 AM    Room 209


There are tangible benefits to integrating the bioprocessing equipment in a facility into one continuous network of systems and data. The cost and effort to integrate the multiple pieces of equipment will be noticeably lower when considered early in the design phase. Key considerations include redundancy, flexibility, multiproduct production, communication network choice, customization versus cost control, and alignment across sites. We have gained valuable experiences integrating different pieces of equipment into a single solution and identified key elements for success.

Presenter: Peter C. Genest, Director of Automation Offerings and Strategy, GE Healthcare
Peter is a subject matter expert on single-use products with extensive experience at GE Healthcare providing global technical support as the lead solution architect. Prior to GE, he gained hands on experience in technical and manufacturing roles in biomanufacturing at Wyeth and as an engineer at Integrated Process Technologies. Peter is focused on designing customer-centric solutions that incorporate technologies that drive efficiency and flexibility. Peter earned his Bachelor’s degree in Chemical Engineering at Villanova University.

Dr Phil Vanek, GM Cell Therapy Growth Strategy

Technical posters

Process economy impact of using a highly alkaline-stable, high-capacity protein A chromatography resin

Any decisions related to the design of a mAb capture step in a purification process will always be strongly influenced by economic considerations. As every process is unique, the benefit of a resin will vary with the process scenario. The scenario, in turn, relates to the desired process outcome like shorter processing times, increased productivity, or increased resin lifetime to name a few. This study consists of a process economy simulation that aims to demonstrate the influence of the performance of three protein A chromatography resins on the main process output parameters. One critical aspect in such a comparison is the required number of batches produced per year. In a clinical production scenario, only a part of the resin lifetime is typically utilized. While in a commercial manufacturing-scale setting, the resin cost will be distributed over the entire resin lifetime. As will be shown, the influence of the dynamic binding capacity and alkaline stability for the process economy per batch can be substantial.

Opportunities, challenges, and economic drivers for start-to-finish continuous biomanufacturing

Continuous unit operations have been used successfully in manufacturing of several approved products with a collective revenue of 25 Bn USD annually. Many large biopharmaceutical organizations are exploring more potential solutions that could drive continuous operations on the manufacturing floor. Continuous biomanufacturing carries the hope for achieving the next level of efficiency through significant increases in productivity, floor space reduction, and lower capital cost for manufacturing facilities as well as lower production costs. Combining many innovative, promising unit operation technologies with single-use equipment can offer significant economic advantages over batch processing in traditional stainless steel installations. Adopting advanced process design will need an accurate business case and risk profile for implementation. Within the risk profile, assurance of patient safety and supply through product quality demonstration will be critical. Optimizing the operating space of an entire process, versus a unit operation, will call for thoughtful automation and control strategies. Simplification of equipment design and operator interface points will also be key to success.

Benefits of automated in-line buffer preparations

A single biopharmaceutical requires multiple buffers of a wide range of formulations. Because of the large volumes required, and the complexity of them, buffer preparation can easily become a bottleneck in the manufacturing process. Traditionally, buffers are prepared manually according to specific recipes in the volumes needed for the process, and due to the quantities used, buffer management will require careful planning. In addition to significant labor investment, there is a risk of human error associated with such a time-intensive manual activity. Buffer variability can affect both quantity and quality of the final product. Also, associated with the cost is the floor space required for the preparation and storage of such large buffer quantities. We present a lean approach that automates the buffer preparation using premade stock concentrates connected to an Inline Conditioning system. Buffers of different formulations for mAb and plasma processes have been prepared in an automated, consecutive manner, minimizing manual interactions. To further reduce the time and space required for buffer preparation, ready-made, highly concentrated, low-volume stock solutions were used. Feedback regulation of the final buffers, using dynamic control, ensured accurate formulations. We also exemplify the benefits of this approach, both operationally as well as economical.

Showcase

Understanding raw material variability

Control batch consistency and drive bioprocess improvement by understanding the relationship between raw materials and process results.

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Accelerate process development

With the right tools and support you can balance innovation, speed, and robustness in your late-stage process development.

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Reach your processing potential through an integrated approach

Gain operational productivity and streamline product transfer with a synchronized automation platform.

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