From mg to kg: first steps towards a scalable process for drug substances

Individualized, precision medicine is an evolving medical model and is key in helping clinicians reach accurate diagnoses and effective treatment plans for many patients. There are much promise and hype around precision medicine, but implementing and scaling a precision medicine program is challenging. Multiple disciplines must collaborate in order to reach an accurate diagnosis and effective treatment plans. Unfortunately, information is frequently in sales, disparate systems, or lost.

With Microsoft Azure DevOps, healthcare IT teams get a combination of processes, industry best practices and proven tools to make the most of their DevOps initiatives. The webinar discusses how organizations can leverage it to accelerate DevOps implementation.

Increasingly, the conventional ways of maintaining pharma equipment call for a digital alternative. Non-wear-based failures such as operating excursion and changes in operation plans make up to 80% of equipment failures.

Following the patent of the innovative “Espresso” intravenous delivery device, the Italian Biochemical Institute (IBI) “Lorenzini” commissioned Comecer to construct a filling line to meet the unique requirements of the solution. Particle Measuring Systems’ advisory team leveraged their industry and regulatory expertise to oversee the development of the aseptic filling process and the environmental monitoring system by applying proven risk management techniques. Using this case study, we provide practical insights for Quality by Design principles with input from IBI and Comecer.