Cambridge BioProcessing Technology Seminar - June 11, 2013

Please join us for this FREE event to learn more about the latest advancements in bioproduction technologies.

Time		Session
8:30 a.m. - 9:55 a.m.		Registration and Continental Breakfast
9:55 a.m. - 10:00 a.m.		Welcome and Introduction to Program
10:00 a.m. - 10:45 a.m.		Characterizing single-use bioprocess container films - 10 critical material characteristics
10:45 a.m. - 11:30 p.m.		Metabolic Pathway Design Process: Cell culture media and process optimization approaches for optimal biotherapeutic production
11:30 a.m. - 12:45 p.m.		Lunch
12:45 p.m. - 1:30 p.m.		HyPerforma S.U.M. DS 300 and HyQ Harvestainer BPC
1:30 p.m. - 2:15 p.m.		HyCell CHO Medium: targeted for high cell density and productivity across a broad variety of CHO clones
2:15 p.m. - 2:30 p.m.		Refreshment Break
2:45 p.m. - 3:15 p.m.		Turnkey Open Architecture
3:15 p.m. - 4:00 p.m.		Panel Discussion: Maximizing bioprocess efficiencies in single-use

Cambridge BioProcessing Technology Seminar - June 11, 2013

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Boston Marriott Cambridge

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Agenda Abstracts

Characterizing single-use bioprocess container films - 10 critical material characteristics

Biologics production is increasingly reliant on single-use flexible containers for such critical applications as sampling, harvest, storage and as a shipping container. Flexible container systems consist of plastic films, ports, tubing and fittings. Performance of a specific container system depends on the materials and quality of construction as well as the conditions and constraints imposed by the application. The integrity of stored contents depends primarily on the characteristics of the film - which is the most important component of any flexible container system. The speaker will discuss the essential characteristics of flexible single-use containers and how these parameters influence any interactions between the flexible container and its contents.

 

Metabolic Pathway Design Process: Cell culture media and process optimization approaches for optimal biotherapeutic production

Clonal variation in production clones drives unique nutritional demands in order to achieve optimal bioproduction. A media optimization approach that has the ability to thoroughly evaluate the nutrient demands specific to that clone for improved productivity is critical. Design of experiment factorial strategy along with our Thermo Scientific™ Metabolic Pathway Design™ process has been successfully used to alter formulations in order to reduce the effect of limiting factors and drive key metabolic pathways in order to minimize waste and maximize productivity. High-throughput screening (HTS) equipment facilitated the development and testing of the media formulations. Development and comparative analysis were performed in 96-deepwell plates with subsequent scale-up and comparison of promising formulations in shake flasks and bioreactor studies. Results revealed exceptionally similar trends in both cell density and product quantity, validating the HTS plate design and Metabolic Pathway Design process. This strategy has been successfully utilized to develop clone specific media formulations and supplement feeds. Case studies will discuss specific optimization work.

 

HyPerforma S.U.M. DS 300

Single-use mixers offer significant advantages by eliminating the need for cleaning and sterilizing, reducing the risk of cross-contamination, and reducing cycle times. The Thermo Scientific™ HyPerforma™ Single-Use Mixer DS 300 (S.U.M. DS 300) provides enhanced mobility, interoperability, and modularity previously unavailable from mixing solutions. It can dock into multiple mixing barrels in 50, 100, 200 and 300L sizes. Single-use bioprocessing container bags were designed for each drum size. It is designed to efficiently mix powder-to-liquid or liquid-to-liquid solutions at different volumes for a wide variety of bioprocess applications: hydration of powdered media and buffers; sterile mixing of buffer solutions; cell culture media with sera and reagents or other process fluids; and pooling sterile liquid fractions. The HyPerforma S.U.M. DS 300 system adds value to your process by mixing and storing in multiple drums economically while maintaining a smaller footprint. You can now achieve greater process flexibility by doing more with less.

 

HyQ Harvestainer BioProcess Container

The many benefits of single-use bioprocess containers continue to drive development of innovative designs for increasingly sophisticated and specific bioprocess applications. The Thermo Scientific™ HyQ™ Harvestainer™ BioProcess Container (BPC) is our latest innovation in single-use technology and is designed for bioprocess operations that require the separation of microcarrier beads from cell culture supernatant. Until now single-use options for this process step were limited, requiring a substantial investment in equipment and its upkeep. Some end-users avoid these expensive options but sacrifice product yield in attempting to manage costs and streamline processes. The speaker will provide an overview of cell culture-based vaccine production with special emphasis on microcarrier beads / cell culture supernatant separation using the HyQ Harvestainer BPC system.

 

HyCell CHO Medium: Targeted for high cell density and productivity across a broad variety of CHO clones

The clonal variation observed in various bioproduction CHO clones has increased demands for a versatile high performing cell culture medium. The Thermo Scientific™ Metabolic Pathway Design™ process and design of experiments approach to mixture design were utilized to develop Thermo Scientific™ HyCell™ CHO medium that will work well for the majority of the CHO clones being used in bioprocess production. High-throughput screening allowed for inclusion of more individual cell lines, increased component factor-levels and mixture design treatments, and higher number of replicates. Developmental work was performed at the 96-deepwell scale, with subsequent scale-up and comparison of promising treatments at shake flask and bioreactor levels. The HyCell CHO medium development approach and comparative performance will be presented.

 

Turnkey open architecture

The Thermo Scientific™ HyPerforma™ Single-Use Bioreactor is the market leading bioreactor in stirred tank design. We have hundreds of installed systems worldwide used to grow numerous cell lines in a variety of processes. The bioreactor consists of a stainless steel outer container and a single-use bag assembly. The system can be ordered either in an open architecture format or as a turnkey system. The open architecture design allows customers to: integrate with any control platform on the market; plug-and-play through standard disposable connectors; avoid the costs of investing in an additional control system; and have the ultimate flexibility to choose the control platform they want. Get your turnkey solution using the control platform of your choice for either cGMP or non-cGMP applications.

 

Panel Discussion: Maximizing bioprocess efficiencies in single-use

Maximizing bioprocess efficiencies in single-use is a natural extension of adopting single-use strategies and remains a focus for the industry. Anticipated topics for this panel discussion include: scaling out versus scaling up, challenges faced when converting to single-use technologies, optimizing mammalian cell culture techniques utilizing single-use, regulatory issues faced by today’s biopharm industry, etc.

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