Zero Questions: A Phase 2 IND, Two Tech Transfers, and a 10-Person Biotech

The client had to execute, in one engagement, a highly complex program that most organizations sequence over multiple years. With a 10-person internal team, any operational or communication gap between technical, quality and regulatory execution would translate directly into program delays or regulatory risks. The critical complexities included:

• Technical and Process Intensification: Transferring the CHO-based DS manufacturing to a European CMO at 1,000 L scale, while simultaneously transitioning the process from fed-batch to perfusion, introducing a new capture resin, and advancing a high-concentration formulation.
• Delivery Presentation Redesign: DP manufacturing transfer to a U.S. CDMO into a 2 mL prefilled syringe (PFS), which demanded complex mixing studies for thawed DS pool, and a revised sterile filtration strategy following a critical filter change.
• Logistics and Infrastructure: Managing analytical method transfers, comparability and stability studies, and a reference standard strategy distributed across multiple international laboratories, all while maintaining full quality oversight and data verification on an aggressive Phase 2 timeline

Syner-G deployed an integrated, cross-functional team that operated as a true extension of the client’s organization, covering CMC, technical operations, quality assurance, and regulatory authoring under a single program leadership model. By eliminating traditional consultant silos, the team led high-level strategy while owning day-to-day execution, proactive risk management, real-time decisionmaking during manufacturing, and continuous CDMO oversight.