Time: 8:30 a.m. - 4:00 p.m.
This unique training opportunity will provide hands-on experience through the entire manufacturing process. You will receive an introduction to all phases of the manufacturing process and have the chance to operate the machinery through all phases (Upstream, Downstream, Analytical and Fill/Finish) of the process, from start to finish.
The session features hands-on instruction with various cell culture expression systems and introduces attendees to the techniques, methodologies, principles and applications of anchorage-dependent and suspension-adapted cell lines. Participants will track their own anchorage-dependent and suspension-adapted cell lines over a two day period. Attendees will also prepare, inoculate and harvest a cell culture bioreactor.
The session will provide hands-on laboratory exercises and classroom instruction on recovery and purification strategies for biotechnology products, especially proteins. Participants will integrate theory with practice in areas such as cell separation, cell disruption, chromatography theory and systems, sample preparation, columns and packing, adsorptive chromatography and elution optimization.
This industry-driven and application-focused laboratory session offers an avenue for training the next generation of biopharmaceutical analytical scientists. Laboratory experience utilizing NIST reference materials will provide an unparalleled simulation of industry-relevant characterization technologies. In addition to exposure and hands-on experience with state-of-the-art equipment, a series of lectures will be given to provide the requisite theory and industrial applicability of the methods.
This session provides individuals with an understanding of the fundamental principles governing aseptic processing. The training will cover the systems associated with aseptic processing and how they work together to help ensure a sterile product. Participants will benefit from hands-on aseptically filling activities, equipment and instrument demonstrations and group projects designed to complement the content presented in the lectures.
Who Should Attend
This course is only open to U.S. FDA employees.
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Upon completion of this course, you will be able to:
- Examine and test bench and pilot scale cell culture equipment
- Apply recovery and purification strategies for biotechnology products
- Demonstrate separation science in ensuring therapeutic protein quality by utilizing ultrahigh-performance liquid chromatography and capillary electrophoresis
- Identify risks of product contamination using airflow visualization techniques
- Examine the media fill operation to ensure appropriate observations and interventions
This course does not provide ACPE Continuing Education Credits.
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PDA Training and Research Institute4350 East West Highway, Suite 150
Bethesda, Maryland ,
This course is taught by subject matter experts from the pharmaceutical industry and academia.