Contingency Planning for Biopharma Manufacturing

Across industries, businesses can suffer the repercussions of blackouts, fires, computer hackers or the havoc of Mother Nature. Should a disruption of this kind occur, a company may be forced to suspend operations for days, weeks, months, or indefinitely. Most businesses can and do recover, but in the case of biotechnology, business interruptions that result from such events are potentially catastrophic.

Biotechnology, pharmaceutical and biopharmaceutical operations are particularly susceptible to any disruptions in their processes. Colonies of microbes can be destroyed or experiments with animals can be ruined by even the smallest changes in temperature and humidity in a laboratory, resulting in potentially disastrous operational delays as replacement colonies or suitable animals are found so that operations can resume. Delays can be further exacerbated because of rigorous regulation of the biotechnology industry by governmental agencies at various levels.

When a business shuts down due to smoke, fire, flood, or any other destructive event, it is the Food and Drug Administration (FDA) that has the final call on when, and if, operations will ever resume. The approval process can take months, maybe even years. Biotechnology firms often find themselves returning to square one, again needing to satisfy applicable facility- and supplier-qualification requirements and, in some cases, perform lengthy validation exercises. Should a significant interruption occur at a start-up company that relies on funding from venture capitalists or angel investors, these financiers may deem the cost of further involvement too risky and back out. In this case, the company may never recover. For larger, more established companies, considerable delays may prohibit the company from receiving the FDA’s approval on schedule, which can allow competitors to gain the edge in the market. Given these realities, insurance is not enough.

In order to survive a disaster or other business shut down, biotechnology companies need to combine their insurance portfolio with an effective disaster-recovery plan that will serve as a road map, providing directions the company will take if a catastrophe or other business interruption strikes.

• Email This Page
• Print This Page