Consider these 3 areas in upstream to improve your process yield:
As your cell expansion increases, consider how to scale your harvest process. By having a scalable manufacturing process, including reagents, raw materials, and fluid transferring equipment, you reduce the risk of contamination, and extra process development efforts.
Maintaining the integrity and quality of the therapy in the downstream process is critical, as there are increased chances of potential issues of sterility or process impurities that may result in batch failure. It is important to consider the quality management system (QMS) and quality standards of the critical raw materials supplier you partner with to avoid those potential risks.
The focus during the last stage of manufacturing is stabilizing the viral vectors utilizing high-purity chemicals and excipients. The advantage of using high-purity chemicals and excipients is to improve drug stability so more patients can receive life-altering therapies.
As production volume scales, the fluid transfer and addition between process steps can be overlooked. The fluid path involves many critical process parameters (CPP) such as process time, pressure, flow rate, and shear force. Having the proper technologies enable better process control and ultimately increased manufacturing consistency.
