Lesson Code: BPU-1100 (PREMIUM LESSON) 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.
Lesson Code: BPU-1108 (PREMIUM LESSON) Following on from BPU-1100, 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.
Lesson Code: BPU-1105 (PREMIUM LESSON) 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.
Lesson Code: BPU-1104 (PREMIUM LESSON) 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.
Lesson Code: BPU-1106 (PREMIUM LESSON) 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.
Lesson Code: BPU-1107 (PREMIUM LESSON) Describes mammalian cell culture in the biopharmaceutical industry, how such cultures are controlled and important considerations in maintaining optimal cultures.
Lesson Code: BPU-1101 (PREMIUM LESSON) 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.
Lesson Code: BPU-1103 (PREMIUM LESSON) 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.
Lesson Code: BPU-1102 (PREMIUM LESSON) 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.
Lesson Code: BPU-1110 (PREMIUM LESSON) 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.
Lesson Code: BPU-1109 (PREMIUM LESSON) Provides an overview of the principles and practices of formulation and packaging processes in a modern biopharmaceutical manufacturing facility.
Lesson Code: BPU-1113 (PREMIUM LESSON) Describes freeze drying (lyophilization), 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.
Lesson Code: BPU-1111 (PREMIUM LESSON) An overview of the process design stage of process validation, describing how a biopharmaceutical manufacturing process can be defined using a Quality by Design (QbD) approach that emphasizes accumulated scientific knowledge and quality risk management.
Lesson Code: BPU-1112 (PREMIUM LESSON) An overview of the qualification and continuing verification stages of process validation, intended to demonstrate that a biopharmaceutical process is capable of reproducible commercial manufacturing and to provide ongoing assurance that the process remains in a state of control.