One of the things that I've learned that is very important to our clients and to our own organization is risk management. The management of risk is part of all business operations; however to those in the biotech industry that are manufacturing cell based therapies, risk mitigation is of utmost importance. The costly nature of your irreplaceable samples, valuable cell lines, and other high value product such as cell-based drugs, biologic active pharmaceutical ingredient (bio-API), dictates you and I to plan for the full continuum of risk. In this two-part video series, I'd like to share with you some of the questions you may ask yourself, or those you consider entrusting with your valued samples.
Risk Threat Assessment and Events to Consider
A risk threat assessment is very much a subjective process. For example, you could have years of mild weather or little opportunity for terrorism, leading you to believe these threats are very low in probability and thus, a minor concern. However there's always the potential for sites near government buildings, major airports, or major cities to be targeted. Therefore it's important to not only assess situations, but also the severity of the type of risk and the potential impact. Weather related risks may also be unlikely to occur but could leave serious damage behind, potentially resulting in an extended power outage or other events that could impact sample integrity. The image on the left identifies some other events to consider as part of a threat assessment.
It's important to take these events into account as part of your risk assessment. If a realistic, well-researched threat assessment has not been performed then the risk mitigation strategy is based on guesswork.
Emergency Action Plans
Emergency Action Plans should be written, reviewed regularly, and if changes are warranted they should be updated as necessary. These plans need to be tested and the best way to do so is via a walk-through or some form of tabletop exercise. Most importantly, employees need to be well-trained on these emergency action plans.
Through a well-conceived risk mitigation strategy, facilities can be designed to go beyond the minimum code of standards and samples can be split between multiple facilities. By taking into account the important items in your risk threat assessment you can ensure that your facility can withstand the types of events that may pose a challenge.
To further understand risk and how to successfully manage high value biologics, please watch our video below and stay tuned for Part 2!