LIFE SCIENCES
Shaping Compliance for Your New Biomanufacturing Facility If you have a new biomanufacturing site in the works, you can open doors to a productive, compliance-forward facility with these strategies. By Roger Humphrey, President, Life Sciences Division, JLL
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xtreme demand…vigorous reshoring… unprecedented funding…the biotech boom is upon us — and inspiring industry leaders to ask how real estate can help scale up productivity and innovation. Now the hunt is on for new sites where compliance and operational practices won’t just avert disruption — they’ll actively fuel speed to market, too. Pressure is mounting to expand production capacity, but this is not a sector where any quality industrial space will cut it. In the highly regulated biologics arena, shrewd biomanufacturing site selection is critical to short- and long-term success. As JLL’s Travis McCready notes in his recent Area Development article,1 compliance and operations play a vital part in accelerating an effective site launch. To reduce risk and extract the most value possible from a biomanufacturing facility, companies need to be able to anticipate and address regulatory and technical operational challenges from the get-go. Following is a closer examination of why compliance and operations considerations need a front seat in planning — and opening — an agile, resilient biomanufacturing facility.
How to Fuel Biomanufacturing Facility Compliance A hair-raising two thirds of drug shortages are triggered by manufacturing disruptions related to product or facility quality problems. But rigorously informed quality and safety standards help alleviate the kinds of
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missteps that lead to compliance issues — and their cascading disruptions and cost impacts. With life sciences enforcement on the rise across the board,2 biotech companies must ensure prospective facilities will be managed in compliance with constantly evolving FDA regulations governing safety, sanitation, and quality-control procedures. To proceed, consider the following best compliancerelated practices for all biomanufacturing facilities — new and old alike: 1. Proactively monitor and anticipate regulatory inspection and enforcement priorities. Requirements and enforcement trends are perpetually changing, as the FDA and other authorities raise new issues and uncover enhanced compliance practices. Case in point: the FDA’s closer focus on pest control in recent years led directly to updated requirements and additional enforcement activity. Prepare for inspections and avert unexpected enforcement attention by staying abreast of evolving regulatory trends. 2. Increase visibility around compliance and enforcement which could impact facilities. Too often, facilities compliance knowledge and experience is siloed, with disparate parties responsible for compliance, facility engineering, manufacturing, and quality. A more collaborative approach will help your organization efficiently share news and insights to improve facilities quality across the entire system. For example, if you establish a central facilities compliance team, they can easily exfor free site information, visit us online at www.areadevelopment.com
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