Leucine makes drug manufacturing compliance less difficult


Leucine makes drug manufacturing compliance less difficult -Gudstory

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The compliance process at pharmaceutical manufacturers is complex and prone to errors as many still use paper-based systems to record manufacturing steps. These paper records are reviewed by FDA auditors to ensure that guidelines are followed, but they are prone to errors, which often lead to warnings. This results in higher costs and slower manufacturing. Lucene seeks to make the compliance process more efficient with its compliance cloud platform for the pharmaceutical industry. It automatically creates digital manufacturing records and uses AI to identify the root cause of deviations.

New York-based Lucene today announced it has raised a $7 million Series A led by strategic investor Ecolab Inc. Participants include returning investors such as Pravega Ventures, Axilor Ventures, Techstars and angel investors. Founded in 2019, Leucine is currently used by more than 30 companies in more than 300 pharmaceutical manufacturing facilities in 10 countries, including the US, India, Brazil, Mexico and the UAE. Its target customers include new biotech companies and pharmaceutical giants.

Lucene describes itself as “a digital twin of the pharma manufacturing shop floor.” It enables real-time performance monitoring and compliance management, analyzes root cause deviations from proper operating procedures, advises users on how to improve efficiency and generates manufacturing records and audit reports. This can be incorporated in as little as eight weeks thanks to a proprietary AI-enabled system that digitizes paper SOPs to create custom workflows. Gera says Lucene can reduce the digitization cycle of a batch cycle from six to eight weeks to just three to five days.

In addition to its funding, Lucene also today announced the beta launch of Lucene 10X, an AI framework that leverages features like digitizing paper-based SOPs and creating dynamic production planning with production managers to ensure timely batch delivery. works. It also rapidly analyzes the root cause of deviations in the manufacturing process by analyzing data from text-based records, logs and staff interview transcripts.

User interface of drug compliance platform Lucene

Lucene user interface

Before starting Lucene, co-founder and CEO Vivek Gera worked as a compliance and automation consultant at Fortune 500 companies. He told TechCrunch that during his work, he realized the scale of non-compliance issues and their impact on the bottom line. For most of his projects, he introduced companies to technology that helped improve compliance.

“However, I noticed that most of the older players in this space did not offer solutions that were design-compliant and also did not provide any insight to manufacturers despite hosting huge amounts of data,” he says.

This led to the formation of leucine. By working with co-founder Mustaq Singh Bijral, whose background is in product management and data science, Gera says Lucene was able to build a data-driven product from day one, with the goal of creating a digital platform that Be easy to use and have built-in compliance guidelines and process interlocks that ensure compliance.

Gera says there are legacy compliance systems that also offer pharmaceutical manufacturing floor digitalization, including traditional manufacturing execution systems (MES) like Siemens and Rockwell and newer solutions like MasterControl, TrackWise, and Neat. But he says that in many the implementation cycles are too long. Compared to eight weeks for leucine, it is more difficult to adapt and is siloed. They also don’t provide insights that would help prevent potential compliance problems.

Lucene also differentiates itself from its competitors by using its LLM-based proprietary Electronic Batch Manufacturing Record (EBMR) to transform paper SOPs into digital workflows within minutes instead of months. Gera said EBMRs are the most important documents in the pharmaceutical manufacturing process because it records every step and is reviewed by FDA auditors to see if manufacturers have followed GXP or quality guidelines.

“Our models are trained on massive amounts of pharma data and they enable us to deliver value to our customers faster than anyone else,” Gera said. “Our platform serves all use cases on the shop floor, from batch planning to batch release, and breaks down data silos, providing a single source of truth.”

Over the past 12 months, Gera says the number of features using Lucene has grown 100%, with a 300% increase in users. That’s because features are expanding the use cases for the platform. It monetizes through a SaaS model with tiered pricing that scales up based on volume. Leucine will expand its platforms with more solutions to improve compliance and productivity across the entire pharmaceutical manufacturing ecosystem. It also plans to improve its AI co-pilot feature.


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