Post-Diploma Certificate in Biopharmaceutical Manufacturing under the Advanced Diploma in Medical and Pharmaceutical Technology (ADMPT)


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Post Diploma Certificate in Biopharmaceutical Manufacturing Module Synopsis Upstream Processing The module will provide an overview of the processes involved in producing biopharmaceuticals from raw materials. The module will cover cells as biocatalysts, applications of recombinant technology, cell banking, bioreactors, bioreactor operation and factors involved in the scale of animal cell cultures from flask to reactor. Issues relating to end product accumulation and the quantitation of cell growth will also be covered. Practical sessions will include the methods of enumerating cell populations and the operation of laboratory scale bioreactors. Downstream Processing The module will cover the purification of recombinant proteins. Topics will include large scale cell separation and affinity, ion exchange and gel filtration chromatography. Issues relating to the packing of columns and the selection of column packings will also be covered. Drug Formulation This module focuses on the design and formulation of two-phase pharmaceutical products, including suspensions, emulsions and solid pharmaceutical products, particularly as they relate to the formulation sterile drugs. Topics include drug formulations, processing of sterile drug formulations, preparation of pharmaceuticals, specialized dosage forms, GMP and Validation.

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