Description
Biotechnological products are complex molecular entities, manufactured in living systems which are - by their nature - inexact. As a result, the composition of these products is influenced by the method of manufacture, making manufacturing control and characterization a challenge. Emerging concepts in the establishment of a process design space for biologically derived products will be addressed. Products manufactured in living systems are also highly susceptible to the environment in which they are manufactured and quality of the raw materials used. A discussion of manufacturing facility requirements and the application of cGMP over the course of product development and commercialization will be included.
The benefits of attending this course include: Rapidly obtaining a clear, concise overview of the current regulations applicable to the production of biopharmaceuticals. Distinguishing the product safety concerns associated with manufacturing of biologically-derived products from traditional chemical products. Understanding the key elements of different expression systems and downstream processing steps. Getting a view from the perspective of regulators on the nature and format of process data required throughout the lifecycle of biopharmaceutical products.
