Biopharmaceutical manufacturing is a complex and expensive business, where the personnel involved face a variety of regulatory and operational challenges including:
- Working consistently in compliance with current industry GMP (Good Manufacturing Practice) regulations.
- Dealing with complex biological systems and manufacturing technologies.
- Maximizing product yields while ensuring an extremely high level of product purity.
These challenges cannot be successfully met without the input of a competent, well-trained workforce.
Introduction to biotechnology and biopharmaceuticals. The role of DNA and proteins in the body is explained along with the key techniques of Recombinant DNA Technology and Monoclonal Antibody Technology. The advantages and characteristics of biopharmaceutical products are explored and the main types of products described. Key differences between biopharmaceuticals and ‘traditional’ pharmaceuticals are also highlighted.
Describes mammalian cell culture in the biopharmaceutical industry, how such cultures are controlled and important considerations in maintaining optimal cultures.
Provides an overview of the functioning of mammalian cells, the roles DNA and RNA play in the cell in producing proteins, and how these can be manipulated to produce therapeutic proteins and other useful biologics.