Pharmaceutical companies, despite their high-tech nature, still rely on old-school, manual compliance work. This outdated approach exposes them to regulatory risks and high costs.
Enter Leucine, a New York-based company that’s shaking things up with a digital solution.
Leucine’s CEO, Vivek Gera, is promising a platform that will wipe out compliance failures and save pharma companies a pretty penny.
“We set out to build an easy-to-use digital platform that had built-in compliance guidelines and process interlocks to enable compliance by design,” Gera explains.
The Food & Drug Administration (FDA) issues hundreds of warnings and citations each year due to manufacturing issues in the pharmaceutical sector. In 2022 alone, it issued 466 “Form 483 handouts”.
From safety procedures to equipment issues, pharma companies are grappling with compliance.
Gera believes the root of the problem lies in the reliance on paper to record compliance processes. With a typical manufacturing facility tracking 800 to 1,000 processes, failures are bound to happen.
Leucine’s digital solution starts by digitizing compliance handbooks. The platform uses artificial intelligence (AI) tools to identify and organize processes and regulations.
It then integrates with the company’s other IT systems to ensure compliance processes are followed correctly. If there’s an error, it issues a warning.
Gera claims that Leucine’s platform can eliminate two-thirds of FDA warnings related to procedural areas during manufacturing.
He also highlights the potential for productivity gains, with technicians spending less time on paperwork and more on production. Leucine estimates a typical facility can reduce costs by around $350,000 a year.
Leucine has already signed up around 35 pharma companies to its platform, which is used in about 300 facilities in 10 countries.
Despite competition from large businesses like Rockwell and Siemens, and newer players like Mastertrack, Kneat, and Trackwise, Leucine’s investors believe its use of AI will give it an edge.
“This latest funding round will enable Leucine to bring the power of large language models and associated technologies to make significant advances in pharma manufacturing,” says Rohit Jain, co-founder and partner at Pravega Ventures.
The funds raised will be used for product development, particularly enhancing Leucine’s AI capabilities, and building a sales and marketing function.