CUSTOMER: A GLOBAL LEADER IN HEALTHCARE
This BIOVIA customer is one of the world’s largest companies engaged in the research, production and distribution of pharmaceutical, consumer healthcare and vaccine products. The company is currently developing a broad offering of biologics products in addition to their sizeable small molecule portfolio. The growing complexity and diversity of their expanding product lines, as well as the acceleration of clinical trial processes, has put their Chemistry, Manufacturing and Controls (CMC) organization on the critical path for commercial product launches.
CHALLENGE: POORLY INTEGRATED LAB SYSTEMS, WORKFLOW INEFFICIENCIES
This biopharma company’s primary challenge is to accelerate innovative drugs to market. They realized that this would require a transformation of CMC processes that would not only accelerate isolated workflows but also eliminate transient disruptions of workflows along the value chain, specifically between R&D and Manufacturing. In many cases, experimental records, recipes and scientific results were stored in multiple Excel files, scanned PDF documents and siloed lab solutions, many of which did not use the same conventions from lab to lab or scientist to scientist. Collaboration depended on ad hoc and informal channels such as e-mail, which led to uncontrolled and often long-delayed workflows across departments. Upstream process design did not reflect the needs of downstream manufacturing. Likewise, knowledge accumulated downstream did not flow back to R&D. These disconnects were leading to additional lab work at late stages, workflow inefficiencies, long review times, delayed decisions, excessive effort and wasted material.