Outsourcing Trusted-Weight Dry Powder Chemicals To Support Expansion

The gene therapy division of a major pharmaceutical manufacturer was looking for ways to overcome capacity constraints due to the increased production demands for process liquids and buffers. In order to sustain growth, non-core manufacturing activities, including the weigh and dispense steps in the process liquid and buffer preparation, were identified as bottlenecks impacting the overall production schedule.

After a self-assessment, management concluded that outsourcing their process liquid and buffer preparation activities would be the best path to meet the increasing demand for process liquids without adding significant capital (CapEX) and operational (OpEX) expenditures. With recent investments in their water for injection (WFI) system, they opted to keep hydration (formulation) steps in-house. They reached out to one of their chemical suppliers for trusted-weight dry powders to be dispensed into a specific container that was validated in their process; however, the supplier was not willing to deviate from their standard bioprocess containers (BPCs).

Solution

To efficiently address the customer’s needs, Thermo Fisher Scientific collaborated with the company’s Head of Engineering and Manufacturing Operations to better understand the specific processes and demands within their weigh and dispense area (dry suites). To address the operational and business expansion challenges observed, Thermo Fisher proposed Process Liquid Preparation Services to provide ready-to-hydrate, trustedweight dry powder chemicals.