Seminario en Tecnología para BioProcesos, Buenos Aires - 28 de agosto, 2013

Favor de unirse con nosotros en este evento gratuito para aprender más de los avances recientes en tecnologías para BioProcesos.

(Nota: Agenda está sujeta a cambios. Varios temas en inglés.)

Hora		Actividad
8:30 a.m. – 9:55 a.m.		Inscripción, Desayuno Continental, y Exposición de Productos
9:55 a.m. – 10:00 a.m.		Bienvenida e Introducción al Programa
10:00 a.m. – 10:45 a.m.		"Ventajas comprobadas de operación en la implementación de tecnología de un solo uso" Gustavo Mahler – COO Global, CMC Biologics
10:45 a.m. – 11:45 a.m.		"Caracterizando Películas de contenedores para bioprocesos de un solo uso: 10 atributos críticos de material" Tom McHenry – Associate Director BioProcess Market Development, Thermo Fisher Scientific
11:45 a.m. – 12:15 p.m.		"Medio HyCell CHO: diseñado para alta densidad y productividad para una gran variedad de clones CHO" Scot Kirkendoll – Field Application Specialist, Thermo Fisher Scientific
12:15 p.m. – 1:15 p.m.		Comida y Exposición de Productos
1:15 p.m. – 2:00 p.m.		"Metabolic Pathway Design™ - Estrategias de optimización para medios de cultivo celular y procesos para la producción óptima de bioterapéuticos" Tariq Haq – Senior Product Manager, Medios, Thermo Fisher Scientific
2:00 p.m. – 2:45 p.m.		"Arquitectura Abierta Preconfigurada" Millie Ullah - Senior Product Manager, Thermo Fisher Scientific
2:45 p.m. – 3:00 p.m.		Refrigerio
3:00 p.m. – 3:45 p.m.		"Nuevos Productos: HyPerforma S.U.M. DS 300 y HyQ Harvestainer BPC" Pablo Fernández – Field Application Specialist, Thermo Fisher Scientific
3:45 – 4:30 a.m.		"Desarrollo de procesos biofarmacéuticos con tecnologías de un solo uso. Beneficios, desafíos y limitaciones en la producción local." Francisco Olivera – Jefe de Producción, PharmADN SA
4:30		Exposición de Productos / Partida

Seminario en Tecnología para BioProcesos, Buenos Aires – 28 de agosto, 2013

Sheraton Buenos Aires Hotel & Convention Center

HOSPÉDESE EN EL CENTRO DE TODO
Ubicado en el corazón de la ciudad, el Sheraton Buenos Aires Hotel & Convention Center es un monumento para los pasajeros internacionales. A media hora del Aeropuerto de Ezeiza, el hotel ofrece vistas espectaculares de Buenos Aires y el Río de la Plata.

San Martin 1225
C1104akc Buenos Aires
Argentina

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.

 

Demonstrated Operating Advantages of Single-Use Technology Implementation

CMC Biologics, a leading global cGMP CMO, seeks to improve its commercial and clinical manufacturing operations, quality systems, responsiveness, flexibility, and cost structure. CMC Biologics has successfully implemented single-use technologies (SUT) in numerous ways across two manufacturing sites in the EU and US in the last few years, including single-use bioreactors from 50 to 2000 liters in capacity, single-use mixers from 50 to 1000 liters in capacity, and bin/bag liquid storage systems of varying sizes. This presentation reports lessons learned and benefits derived from the implementation of these technology platforms, with special emphasis given to the utilization of single-use bioreactors.

Gustavo Mahler, PhD – Global Chief Operations Officer, CMC Biologics

 

Bioprocess Design within Single Use Technology - Benefits, Challenges and Limitations in Local Production

Rational process and facility design with Disposable Technology applied for Biosimilars production. Single-Use Technology Applied on a MAb process platform – Case Study. New analytical and regulatory challenges.

Francisco Olivera, MBA – Head of Manufacturing, PharmADN SA

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