AI startup Leucine nets $7M to level up Pharma manufacturing compliance to keep pace with drug innovation.
Investors include Ecolab and Pravega Ventures
Pharmaceutical manufacturing is a heavily regulated sector because of the critical nature of the products it manufactures., yet outdated processes pose a challenge in seamless regulatory compliance. To solve this problem, Leucine, a B2B SaaS startup, secures a game-changing $7 million Series A funding round led by Ecolab Inc. and joined by Pravega Ventures, Axilor Ventures, Techstars, and angel investors. This funding will accelerate Leucine’s Compliance Cloud platform, armed with AI-driven tools, to revolutionize pharmaceutical manufacturing, aligning with industry demands. Today, the company is also announcing the beta launch of Leucine10x, a groundbreaking AI framework designed to serve as a co-pilot in pharmaceutical manufacturing processes
Vivek Gera, CEO & Co Founder 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.”
“Vivek & 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” said Rohit Jain, Co-founder and Partner at Pravega Ventures.
Leucine’s Compliance Cloud serves as a digital twin of the pharma manufacturing shop floor, bringing real-time performance monitoring, compliance management, and actionable insights to the table. For pharma manufacturers, leveraging data can mean the difference between a successful batch and a costly recall. What differentiates Leucine 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 8 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.
“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,” added Vivek Gera. 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 in over 300 pharma manufacturing facilities across 10 countries, including the US, India, Brazil, Mexico, UAE, and others. Over the last 12 months, the company has seen a ~2X jump in the total number of manufacturing facilities using their product.
The new AI capability of the company, Leucine10x 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. Built on proprietary LLM technology, Leucine10x 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.
Vivek Gera remarked: “We’re just scratching the surface; our vision is to leverage AI and technology to bring safe medicine to patients across the world”
About Leucine
Leucine is at the forefront of digitizing pharmaceutical manufacturing, leveraging cutting-edge AI technologies to bring unprecedented efficiency and compliance to the shop floor. Our innovative solutions, from Batch Planning to Batch Release, aim to modernize traditional procedures, replacing paper-based records with a seamless, digital-first approach. Trusted by industry leaders, Leucine not only streamlines the manufacturing process but also delivers actionable insights through its AI-driven analytics dashboard, empowering pharma companies to produce safer and more effective medicines. Leucine is headquartered in New Jersey, United States. For more information, visit www.leucine.io
About Pravega Ventures
Pravega Ventures is an early-stage Venture Capital fund that partners with passionate founders, who are leveraging technology to either disrupt existing markets or create new ones.
