Cytokine Customization for Process Scaling in Cell Manufacturing

Optimizing raw materials to fit your process requirements can provide significant benefits in efficiency, safety, and cost. Customizing cell manufacturing is important to do early in the process, and it takes on increasing importance as a therapy gets closer to commercialization. It is critical to identify a supplier that can function as a flexible partner to enable you to standardize your process at scale and with consistency. Also critical is a partner that is readily accessible to provide technical and regulatory support throughout your process.

Customization can optimize raw material characteristics and formulations for your process. This includes cytokine construct design, physical and functional characterization, formulation, and stability. You determine what the specifications are, and your suppliers should meet those requirements. Often the exact GMP material you require is not commercially available. Research use only (RUO) materials can potentially be utilized in early trials as long as they are appropriately risk assessed. The additional testing and documentation needed to meet GMP requirements can be handled as a customization request. Competing factors need to be balanced to effectively scale developmental protocols into robust and efficient processes for the cleanroom. Consider this example of cytokine supplementation from vials containing 1 mg, 25 mg, or 10 mg (optimized for the process). The choice of cytokine packaging options depends on multiple considerations including risk and cost. Customizing the packaging of a raw material order reduces waste and manufacturing risk and ultimately reduces cost. Wasted material and unnecessary cost are reduced by including the specified amount of material for a given process step in each vial. In addition, customization greatly lessens the manual handling needs which limits the risk of human error in the cleanroom. Bio-Techne offers custom vialing, labeling, and packaging to support you in de-risking your process further. Customizing raw material vialing by activity in international units (IU) instead of mass simplifies media preparation by providing the exact amount necessary in each vial, regardless of material lot. Unless the supplier’s raw material is extremely consistent lot-to-lot, vialing by mass generates uncertainty in material bioactivity and requires additional cleanroom steps of calculations and pipetting.

Bio-Techne can provide made-to-order (MTO) fills of GMP proteins based on activity. Planning ahead for large-scale manufacturing can lessen future costs and/or future problems by limiting material changes, thus lowering the burden of comparability proof during later stages when it is more expensive. Prioritizing scalability and locking in supply chain reliability early requires a consideration of what would elevate a raw material supplier relationship to an ongoing partnership. Consider master supply and quality agreements to ensure that raw materials arrive when needed and meet exacting specifications. Precision fulfillment of your contracts means receiving raw materials exactly how and when you need them. This results in a more reliable and scalable manufacturing process. Your contracts with suppliers should define materials delivery in addition to specifications for quality, consistency, and bioactivity standardization.