Zuwei shared with me that integrated data management across drug development phases from clinical I, II, and III facilitates Chemistry, Manufacturing and Control (CMC) submission and process validation. This integration can significantly reduce the time to market, which is a key component in overall financial performance.
Using instrument independent process automation systems such as the DeltaV system and scalable manufacturing operation management systems, also known as manufacturing execution systems (MES), such as Syncade suite are important to an integrated data management architecture. The operations management software captures and organizes data through the manufacturing process through resource management, operations optimization and quality and compliance requirements.Zuwei noted recent trends—single use equipment and flexible factories—that the process automation system needs go across single use and regular processing vessels and plant equipment. Having the process automation system already in place is becoming popular in early development stage for use all the way up to stainless steel fixed installation in commercial production.
Additional efforts in standardizing the single use equipment and adoption of manufacturing execution systems in early development stages such as preclinical and clinical phase I are a key trend in shrinking overall time to market.
Zuwei also had a recent discussion with several process engineers at a major pharmaceutical manufacturer. The engineers noted how much effort was required within the organization in following a FDA risk-based approach—quality by design (QbD) and process analytical technology (PAT). This is primarily due to confusion and communications disconnects between the process development and manufacturing organizations.
Zuwei believes that this difficulty in implementing PAT may in reality have much to do with this disconnect. We discussed some of the ways to address the challenges of PAT implementations in the post, Establishing a Process Analytical Technology Program.
A successful PAT implementation depends on great QbD work, which mostly resides within the process development organization. Bridging these communications between the process development and manufacturing organizations is something that Zuwei and the Life Sciences consulting team often perform to advance these efforts.
You can connect and interact with other biotech and pharmaceutical manufacturing professionals in the Life Sciences track of the Emerson Exchange 365 community.