Biopharma Manufacturing Processes and Equipment


Biopharma Manufacturing - Fundamentals

Biotechnology and Biopharmaceuticals -

Lesson Code: BPU-800. Introduces biopharmaceuticals and their product characteristics. An easy to understand explanation of the science of biotechnology that underlies biopharmaceuticals is provided. This includes the role of DNA and proteins in the body, along with an explanation of Recombinant DNA Technology and Monoclonal Antibody Technology. The characteristics of biopharmaceutical products are explored and compared to traditional small molecule pharmaceuticals, and the main types of products described.

Cell Biology and Recombinant DNA Technology

Lesson Code: BPU-808. Following on from BPU-800, this Lesson goes a level deeper in its explanation of cell biology and how cells can be manipulated to produce therapeutic proteins. An overview is provided of the functioning of mammalian cells, followed by an explanation of the roles played by DNA and RNA in producing proteins in cells. The steps involved in recombinant DNA technology are outlined, including DNA amplification, insertion of target genes into suitable vectors, before cell culturing is explained.

Biopharma Processes and Equipment

Overview of Biopharmaceutical Manufacturing

Lesson Code: BPU-805. Explains the principles of biopharmaceutical manufacturing by focusing on the processes typically involved in producing therapeutic proteins. The stages of manufacture from upstream, through downstream, to formulation and fill finish are shown, with explanations of the equipment and processes involved. Key concepts of GMP, environmental control, and cleaning are covered.

Bioreactors in Bioprocessing

Lesson Code: BPU-804. Describes the function, design, set-up and control of bioreactors in the biopharmaceutical industry. It examines control parameters such as heat management, pH, oxygen, mass transfer, and agitation, and how the type of cells being produced impacts on bioreactor set up and control. It also introduces the meaning of sterility, and bioreactor cleaning using CIP.

Fermentation in Biopharmaceutical Manufacturing

Lesson Code: BPU-806. Describes how microorganisms are used in fermentation processes as part of biopharmaceutical manufacturing. Areas covered include growth phases and characteristics and conditions, cell banks, media, bioreactors and modes of operation, and the importance of sterility.

Cell Culture in Biopharmaceutical Manufacturing

Lesson Code: BPU-807. Describes mammalian cell culture in the biopharmaceutical industry, how such cultures are controlled and important considerations in maintaining optimal cultures.

Clean In Place

Lesson Code: BPU-801. Explains key concepts of Clean In Place (CIP) technology commonly used in the biotechnology and pharmaceutical industries. It describes CIP processes and procedures and provides examples of best practices that help ensure optimum performance.

Downstream Processing: Centrifugation

Lesson Code: BPU-803. Describes what centrifugation is and the stages of biopharmaceutical downstream processing where it can be used. Primary cell separation using a Disk Stack Centrifuge, and final purification using Ultracentrifugation are explained both in terms of equipment and process.

Downstream Processing: Ultrafiltration and Diafiltration

Lesson Code: BPU-802. Describes the downstream manufacturing processes of ultrafiltration and diafiltration with an emphasis on post-harvest volume reduction and concentration for therapeutic protein products. The components of an UF/DF skid and control of the UF/DF process are also described.

Downstream Processing: Protein Purification - Chromatography

Lesson Code: BPU-810. Describes the use of various chromatographic methods in downstream protein purification including size exclusion, ion exchange, hydrophobic interaction and affinity chromatographies. The basics of a chromatography set-up are covered along with critical factors affecting protein separation such as column packing, resolution, column capacity, pressure and the gel matrix.

Formulation in the Biopharmaceutical Industry

Lesson Code: BPU-809. Provides an overview of the principles and practices of formulation and packaging processes in a modern biopharmaceutical manufacturing facility.

Freeze Drying

Lesson Code: BPU-710. Describes freeze drying, its use in biopharmaceutical manufacturing, the structure of a freeze dryer and the freeze drying process, including critical parameters, cycle phases, process monitoring and control.