AI turns the page on paper-based pharmaceutical compliance

A platform is speeding up drug manufacturing by using AI to streamline compliance processes

Spotted: Making drugs is big business. In 2022, the pharmaceutical manufacturing market was valued at $566.3 billion, and it is set to continue growing, being forecast to reach just shy of $1 trillion by 2030.

With peoples’ lives and health at stake, the industry faces particularly close regulatory scrutiny. But, while new pharmaceuticals may be at the cutting-edge of science, the compliance systems that underpin their production remain largely paper based. These paper trails are prone to errors, which can lead to higher costs and delays in getting life-saving drugs to patients.

US startup Leucine is looking to change this by riding the wave of artificial intelligence (AI) innovation to make pharmaceutical compliance less onerous. The company’s ‘AI-first’ platform acts as a digital twin of the manufacturing shopfloor, auto-generating digital records and providing insights into potentially compliance-compromising issues and their root causes.

The platform is underpinned by several solutions. Leucine10x is an AI co-pilot that provides critical insights, detects compliance and efficiency bottlenecks, and offers a chat function that helps teams make data-based decisions. The company’s workflow builder, meanwhile, streamlines the process of creating, reviewing, and signing off standard operating procedures that provide directions on how processes and tasks should be carried out. The platform further provides, immutable logbooks for recording events and actions, advanced data analytics, solutions for managing domain knowledge, and systems for detecting abnormal conditions.

There are two main uses cases for Leucine’s platform. The first is for executing compliant and error-free batch manufacturing of drugs (most drugs today are manufactured in batches). The second is for validating cleaning processes in labs to ensure compliance.

The startup recently received $7 million in Series A funding to scale up its platform.

Artificial intelligence is having an impact in several different areas of the pharmaceutical industry. Springwise has recently spotted an AI system for streamlining clinical workflow, a system using AI to detect cancer cells, and  algorithms that help to detect cardiovascular disease.

Written By: Matthew Hempstead