Biotech Plant Scale-Up Support Summary

When faced with an aggressive timeline and a strict budget, a biotech company needed to scale its operations from lab-scale production to full commercial manufacturing. Through an operational readiness approach, a specialized team provided integrated support across various disciplines, including the development of a tech transfer plan to guide production scale-up. The team also led equipment and utility qualification efforts, authoring over 80 standard operating procedures (SOPs) for various functions, including manufacturing, quality, and supply chain.

Through this collaboration, a role-based staffing and production plan was established, allowing the client to meet its aggressive goals and successfully launch its new manufacturing site.