Angelo Stracquatanio, Co-founderIn the pharmaceutical and biotech industries, manual and paper-based processes, which still abound in the laboratories increase the risk of errors resulting from measurements and processes incorrectly transferred from the lab to a paper or technical file. Additionally, difficulties also arise in collaborating with colleagues or SMEs located in other geographical areas. In an environment, where life-saving drugs are manufactured, and that requires consistent adherence to stringent regulatory requirements for safety, data collection, and auditing–paper-based processes struggle to support. Having experienced these issues first-hand, the co-founding partnership of a software engineer, Angelo Stracquatanio, along with a process engineer working in the biotech industry, set out to design an enterprise software platform, which leverages Augmented Reality (AR).
According to Stracquatanio, the Co-founder of Apprentice Field Suite, their flagship product, Affinity is specifically built for the highly regulated environment. “Our goal is to help the industry manufacture drugs cost-effectively by improving the competencies of human capital allowing them to do more with less – while simultaneously ensuring access to all of the data and information that they would ever need while performing their job,” says Stracquatanio. Affinity removes paper based processes, provides virtual collaboration, improves adherence to regulatory requirements, and creates automated documentation for laboratories and manufacturing suites. Provided as either a cloud based or on-premises solution, Affinity is specifically built for smartglasses - which can either be monocular or totally immersive 3D devices – that free the lab staff of many manual processes leaving them hands free to conduct experiments and work more efficiently.
Affinity is composed of three separate modules – Tandem, Manuals, and BioCapture. The “Tandem” module allows global collaboration between Subject Matter Experts (SMEs) or vendors improving the speed and quality of development. While this feature is not particularly unique - what is unique is that all regulatory requirements for pharma and biotech are built into the platform making them easily accessible and ensuring the right regulations are applied to the right experiments. The “Manuals” module supports business processes and workflows to improve efficiency.
We built Affinity to be generic enough that similar companies with comparable environments - can also leverage the product and be successful
Manuals allows input from batch records, SOPs, work instructions, and more directly into the smart glasses, –“Hence as you are working - your hands remain completely free and engaged in the experiment,” explains Stracquatanio. Manuals integrates with existing document management or lab notebook systems to pull information into the glasses and provides an audit trail for any given task. The third module is “Biocapture” Biocapture uses computer vision to automatically collect different values within a laboratory environment or a pharmaceutical manufacturing suite such as a bar or QR code, handwriting, labels, sample volumes, digital number displays, and analog gauges specific to a laboratory environment. Biocapture collects the information and converts it to a digital value that is then saved for audit, analysis, and reporting.
The ability to work and collaborate virtually immediately creates an ROI for a client by improving outputs and reducing costs. “For instance, one of the top three pharmaceutical companies is using our solution within their laboratory environment to collaborate cross-border between South America and U.S., and leveraging smart glasses quite successfully in both their laboratory and manufacturing environment,” elucidates Stracquatanio.
Though Affinity was designed for pharma and biotech, it is platform agnostic and already Apprentice is expanding into verticals like chemical and cosmeceutical. The roadmap for Apprentice includes enhancements in their data capturing capabilities and global expansion as new customers seek their services. Per Stracquatanio, “We built Affinity to be generic enough that similar companies with comparable environments - like labs and manufacturing suites - can also leverage the product and be successful with it.”