BLACK MESA

Science requires process.

Our insight defends it.

Modern biomanufacturing processes are both increasingly
capable and complex - involving hundreds of steps and specialized equipment. To prove that a product was manufactured to specification, rigorous documentation practices are used to track the process through every step: "the process is the product".

This rigorous documentation can be challenging in an environment that blends paper batch records, digital records, lab instruments, contemporaneous documentation, and complex process execution. Fully digitized batch record systems are extremely costly to implement and require a lot of adaptations of existing workflows. Paper records - while infinitely flexible - can hinder modern collaboration and make the use of AI or other advanced data analytics extremely challenging.

Black Mesa has developed a system that allows organizations to reap the benefits from both paper and electronic systems without costly and lengthy migrations. It allows users to seamlessly switch between electronic and paper media - automating many of the key steps critical for the development and approval of your processes. The Black Mesa technology also represents a generational leap in how organizations are able to assure the safety, integrity, and quality of their products.

Black Mesa is working with select public and private-sector partners to evaluate and test the technology. If you are interested in partnering with us to usher in a new era of assurance and quality in biomanufacturing, please reach out.

"Without engaging Black Mesa, we would not even know where to start in addressing our security vulnerabilities. They have been incredibly helpful in identifying our security weak points, prioritizing them, and laying out a range of options for addressing them. They have also modulated their advice based on our specific circumstances, and given us the tools to determine how to balance security versus operational efficiency. Many companies would benefit from the services Black Mesa provides."

- Boston-based Biotech Company
(Asked to remain anonymous)

PRESS & RELATED ARTICLES

FRACCHIA, C. - THE NATIONAL ACADEMIES OF SCIENCE, ENGINEERING AND MEDICINE

FRACCHIA, C. - THE AMERICAN FOREIGN POLICY COUNCIL

CHUNG, E. & FRACCHIA, C. - THE FEDERATION OF AMERICAN SCIENTISTS

THE WHITE HOUSE

PHARMACEUTICAL TECHNOLOGY

U.S. DEPARTMENT OF DEFENSE

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CONTACT

Want to talk?

If you’d like to talk about how Black Mesa can support your own biomanufacturing efforts, please send us a note.