Leucine is joining the artificial intelligence (AI) wave sweeping through the pharmaceutical industry after the startup raised $7m in a Series A funding round to scale its platform for drug manufacturing compliance.

The round will aid US-based Leucine in scaling its Compliance Cloud platform. According to the company, the platform could help the pharmaceutical manufacturing sector reach improved compliance, safety, and speed, based on a 16 October press release. The Series A was led by Ecolab alongside existing investors from Pravega Ventures and elsewhere.

AI is becoming essential for drug manufacturers to keep up with increasing treatment demands. Automation is being implemented across many stages of a medicine’s lifecycle. Famous applications include using generative AI in drug discovery, and the use of robotic arms in dispensing. However, compliance procedures have not seen the same level of digitisation.

Compliance is a key part of the drug manufacturing process, with the US Food and Drug Administration (FDA) conducting numerous inspections of facilities to check rules are being followed. Many companies fall short, with the agency handing out 466 “Form 483s” – the document that indicates non-compliance – in 2022 alone.

Leucine CEO Vivek Gera said in a statement: “Paper-based manufacturing records are the industry’s Achilles’ heel, fuelling 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.”

The platform, which acts as a digital twin of the manufacturing shop floor, uses AI to monitor and manage compliance. Leucine says what separates its platform from others is that its AI software can actively provide insights to maintain compliance.

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Gera added: “Our models are trained on a wealth of pharma data, which allows the platform to create custom workflows enriched with good practice compliance measures.”

Leucine says over 30 companies utilise its services, with the platform being deployed in over 300 pharma manufacturing facilities across the world.

The software uses large language models (LLMs) to rapidly transform paper-based information into digital data. According to Gera, the digitisation of a batch paper record goes from 6-8 months to 3-5 days.

A 2023 report by GlobalData predicts that global revenue for AI platforms across healthcare will reach $18.8bn by 2027.

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