Plan for success with your process liquid and buffer preparation
Preparation for manufacturing is a complex and challenging undertaking. Process liquids and buffers are important components within the bioprocessing workflow, and preparation of these solutions can be very resource intensive.
Preparation for manufacturing is a complex and challenging undertaking. Process liquids and buffers are important components within the bioprocessing workflow, and preparation of these solutions can be very resource intensive. The fiscal impact of process liquid and buffer preparation in the total cost of ownership (TCO) goes beyond capital and operational expenditures. There are numerous hidden costs associated with inefficiencies, contamination, batch failures, and personnel devoted to manufacturing process liquids and buffers.
Successfully scaling up to bring a therapeutic to market requires careful planning, but the process is filled with unknowns. Being aware of common inefficiencies, risks, and financial burdens can provide a clearer view of the TCO. In addition to direct costs like personnel, equipment, and space, TCO includes hidden costs like quality errors and process inefficiencies. Understanding these hidden costs is crucial for managing growth and increasing production demands efficiently.
Plan for operational efficiency
Sourcing from a reliable chemical supplier is an essential component in scaling up your process liquids and buffers. Often, several suppliers will be needed to obtain all the raw materials required for various buffers and process liquids. In times of chemical shortages and delays, or unexpected increases in demand, managing the logistics of alternate sources requires additional time and labor. Managing multiple supplier relationships individually and coordinating inbound material receipt can be a very resource-intensive process. Without consolidated orders, freight and shipping expenses will be higher, for multiple individual shipments.
Beyond procurement challenges, raw materials need to undergo quality control (QC) testing prior to preparation for process liquids and buffers. The documentation, validation, and training associated with these processes also present challenges to facilities that must allocate personnel and equipment. Inefficiencies in any step of this process can increase the risk of production delays.