With the introduction of cell therapy and the recent diversity and complexity of pharmaceutical products, we have expanded our understanding of the enormous variety of bacteria, fungi, viruses, and animal forms (including the exotic) on the earth. We utilize cell cultures from humans, insects, plants, and animals and genetically engineer them for our therapies. As a result, we must therefore practice a very careful assessment of our biological processes, plus develop robust containment strategies and designs for the safety of our environment, personnel, and consumers.
While biocontainment may seem like a relatively new topic for the industry, the practice goes back to the days of development of the smallpox vaccine (1796), research by Louis Pasteur (mid-1800s), and the development of the Salk vaccine (1955). It is important to recall that in 1955, the pharmaceutical industry was stunned by the “Cutter Incident,” in which a breach of containment caused thousands of children to be exposed to the live polio virus, resulting in paralysis and death for some of them.
During this interactive webinar, you will learn a brief history of biocontainment as an outgrowth of medical research, especially the effort to develop vaccines for various worldwide diseases. Additionally, you will be provided definition of biosafety levels (BSLs) established by the Centers for Disease Control and Prevention (CDC) based on risk considerations. You will also understand the regulatory landscape for biological agents and, specifically, for designing a facility for an FDA or EU regulated product within the confines of the safety practices dictated by the CDC and design requirements of the NIH.
The course will progress with the physical application of GMP design practices as influenced by the CDC and NIH regulations. The first part of our design discussion covers various processes and their applicable BSL levels, to understand the risk levels and what types of processes must be contained. Finally, you will receive practical (and required) design and building concepts that must be integrated into the GMP process to satisfy the FDA and EU, while taking into account requirements from the NIH and CDC.
- Identify a BSL 1, 2, 3, or 4 based upon process within your project
- Identify the risks at each BSL level
- Understand biocontainment fundamentals from a compliance standpoint
- Understand how engineering and construction can achieve containment compliance
- Understand how the EU and FDA product manufacturing requirements work with Biocontainment