GMP in Biopharmaceutical Development - From Lab Table to Clinic

Short Description

This is a 2-day designed training course wherein various GMP issues that are important for the development process of biopharmaceutical products are dealt with.

This training also discusses the different regulatory standards required during the various phases of the process (development, animal research, clinical phases I, II and III).

The development of medicines up until the clinical phase is paved with all sorts of challenges. These include the scaling up/migration of the production process (from the lab table to a GMP production environment) to the setting up of the correct analytical methods in order to obtain stability data.

These activities should take place at the stage where you have limited knowledge of the product, the production processes and the analytical methods and where it is not clear how to apply the GMP standards required. Furthermore it is also not clear at this stage  which regulatory requirements should apply to which phase of the production process. 

This module will provide more insight into the following subjects:

The life-cycle / development process of a pharmaceutical product

• What does the life-cycle of a medicine look like?

• What steps does a medicine have to undergo from the lab table up until the finished product is approved and brought to the market?

Legislation

• What guidelines must I follow? In which phase of the development process?

Production, characterization and management of Cell Banks and Seed Lots

• In which phase must I generate and characterize a Cell Bank and Seed Lot?

• What does GMP have to do with the generation and characterization of Cell Banks and Seed Lots?

• How many Cell Banks / Seed Lots should I generate?

Risk management

• How to apply risk management during the development process of medicines

• What risk management techniques are available?

Process for development and production

• Do I have to apply full blown GMP from day one or can I phase it in?

• How can I distinguish between the various phases?

Process for validation

• Which processes have to be validated and in which phase of the development process?

• What does the validation of the production processes actually mean?

Test methods and test validation

• When must I validate the analytical methods?

• What does the validation of the analytical methods actually mean?

Stability studies

• What stability data is necessary for clinical phase I?

• How can I obtain stability data for the registration file?

Identifying specifications

• What tests must be carried out on a product?

• How do I prepare the correct specifications?

• Would I need to have the same kind of specifications for material used in clinical phase I as I also would need for the registered product?

Investigational Medicinal Product (IMP): production, testing, release and transportation

• What are the critical considerations for the manufacture, analysis and shipment of an  Investigational Medicinal Product (IMP)?

• What would be expected of you if you made changes to the production process, the analytical methods, the formulation and/or the reference standard during the development process?