Furthermore, the company says the large-scale manufacturing of drugs is being hampered by and suffocated by paper-based records and legacy systems.
Leucine says it is ‘little wonder a staggering two out of three FDA warnings are for non-compliance related to procedures not being followed appropriately’ and listed unclear work instructions of methods, failure to review equipment usage logs and a lack of shared procedures between quality assurance and production departments as problem areas.
The company said the matters are often missed and go unnoticed because of the conventional paper-based systems in the pharmaceutical industry.
In its bid to help, Leucine today (October 16) announced a $7 million series A funding round led by Ecolab Inc., a strategic investor, to scale its compliance cloud platform globally. This round also saw participation from all existing investors, including Pravega Ventures, Axilor Ventures, Techstars, and angels.
Compliance cloud serves as 'digital twin'
Vivek Gera, founder, and CEO of Leucine said: “Paper-based manufacturing records are the industry's Achilles’ heel, fueling not only regulatory nightmares but also ballooning production costs and inefficiencies. The legacy solutions are no better, with their extremely long implementation cycles and rigid, siloed applications that leave manufacturers in a lurch.”
Leucine's compliance cloud serves, it says, as a ‘digital twin’ of the pharma manufacturing shop floor, bringing real-time performance monitoring, compliance management, and actionable insights to the table.
Gera continued: “For pharma manufacturers leveraging data can mean the difference between a successful batch and a costly recall. What differentiates Leucine they say, from some of the legacy digitization tools is its AI-driven capabilities designed not only to digitize pharma manufacturing workflows faster but also to provide proactive insights that enable pharma companies to stay compliant and produce faster and in a cost-effective manner.”
Leucine's platform can be implemented in eight weeks. This speed of implementation becomes possible because of the proprietary AI-enabled digital process builder based on Large Language Models (LLMs) that rapidly digitizes paper SOPs into execution-ready digital formats.
GxP compliance measures
“Our models are trained on a wealth of pharma data, which allows the platform to create custom workflows enriched with GxP compliance measures, enabling us to deliver unparalleled value at breakneck speed,” Gera adds.
“A batch execution procedure is the single most important document in pharma manufacturing. This rapid digitization capability reduces the digitization cycle of a batch record from 6-8 months to 3-5 days.”
Leucine is currently deployed at over 30 companies and in more than 300 pharma manufacturing facilities across 10 countries, including the US, India, Brazil, Mexico, UAE, and others.
The company is today (October 16) also announcing the beta launch of Leucine10x, an AI framework designed to serve as a co-pilot in pharmaceutical manufacturing processes. The company says it will ‘revolutionize how decision-making is done in pharma manufacturing’, enabling production and quality assurance teams to achieve their organization goals with ease and confidence.
Digitalizing paper-based SOPs
Built on LLM technology, the company says it offers an army of AI co-pilots that perform highly specialized tasks such as digitizing paper-based SOPs, creating a digital twin of the shop floor, collaborating with production managers in creating dynamic production plans, thus ensuring on-time batch delivery. Most significant is their ability to speed up Root Cause Analysis (RCA) of deviations in the manufacturing process by quickly analyzing data, including text-based records, logs, and even staff interview transcripts, to identify potential issues or patterns that might not be readily apparent.
Mustaq Singh Bijral, co-founder and CPO of Leucine, said: “We're excited to share that Leucine10x is already operational in select customer facilities under a trusted tester agreement. The response has been incredibly positive, and due to high demand, we're currently enrolling new customers through a waitlist.”
The funding round will support Leucine in refining its AI capabilities and making its AI Co-pilot a trusted partner to the production and quality managers on the shop floor and in expanding its reach to more facilities and customers.
Rohit Jain, co-founder and partner at Pravega Ventures, who invested in the seed round, said: “Vivek and Mustaq have been relentless in their mission to make pharma manufacturing safer. This latest funding round will enable Leucine to bring the power of LLMs and associated technologies to make significant advances in pharma manufacturing. We couldn’t be happier to support them in this quest.”