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Below is a listing of all sessions the speaker is scheduled to present.

Saul Edenbaum

Director, Process Engineering

Integrated Project Services

Speaker Bio

Saul has more than 25 years of Engineering & Construction firm experience in the process development, management, and design of Bulk API, Biotech, and Dosage Form facilities for the pharmaceutical industry. He has actively executed and managed numerous front end studies for projects to manufacture newly developed products for the marketplace in the areas of small molecules and biotech processing including peptides, therapeutic proteins and MAbs. Having served so long as a provider of services to the pharmaceutical industry, Saul is well positioned to identify changes in both existing and emerging trends both in facility design and process technologies.

Tuesday, March 17, 2009

Biotechnology

B-4: Considerations for Upgrading/Modifying Existing Biotech Facilities
Room: 1E11 ~ 10:15AM - 11:15AM (Tuesday, March 17, 2009)

Many facilities constructed in recent years already incorporate the basic capabilities needed to adopt future technologies, support multi-product operations and meet international regulatory compliance. With the evolution of portable disposable manufacturing systems, these existing facilities can be reconfigured for new products and processes. Facilities can be upgraded to increase containment levels, facilitate handling of flammable solvents required for certain types of buffer solutions, and expand downstream processing capabilities. Debottlenecking initiatives designed to enhance clean utility capacities, such as WFI or USP water, clean-in-place (CIP) systems and steam-in-place (SIP) systems, may also be necessary and result in design upgrades. Innovations such as customized nutrients and advanced cell line development are helping provide higher product yields. To accommodate these increases in bioreactor production, the facility's downstream purification operating capacity and unit operations such as ultra-filtration, chromatography and buffer prep, must likewise be increased. Using in-line dilution of concentrated buffer solutions on a large scale, production facilities has increased buffer capacity while minimizing the need for large equipment.

Speaker:

Saul Edenbaum - Director, Process Engineering, Integrated Project Services

Aaron Weinstein - Senior Consultant, Integrated Project Services

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