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.
Addressing critical elements in the manufacturing and regulation of biopharmaceutical products
Our 2 day interactive course will introduce you to the fundamental processes and operations in the manufacture of biopharmaceuticals. Learn about the current regulatory expectations for the manufacturing of biotechnology products from preclinical and clinical development to commercialisation.
Gain a real-world perspective on biotechnology product manufacturing
Identify the major product quality and safety concerns associated with biologically based production processes. Practical aspects of process control, starting with raw materials and cell banks, upstream and downstream unit operations, purified bulk drug substance and formulated/filled drug product, will be presented.
You will be trained to understand the relevant sections of the Quality Module 3 of the ICH Common Technical Document where product and facility information is required to be presented to regulators for review and approval of clinical and commercial applications.
This course is designed for anyone wanting an introduction to biopharmacuetical manufacturing, including but not limited to:
"The use of a wide variety of examples was particularly useful"
"Very nice course! I now have more statistical background to evaluate my assay performance"
"It was a great experience with an atmosphere more like a classroom having excellent interactive sessions"
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Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals