The purpose of this best practice guide is to provide key information and best practices for media supplier partners and companies in the biopharmaceutical industry on the design, development and controls for manufacturing of media and medium solutions to minimize potential variation that may impact product quality, process performance and operational efficiency and costs. It is intended that this best practice guide can be used to support a proactive approach to evaluation and self-audit of internal processes.
Compared to more complex unit operations, for example cell culture process in a bioreactor, the medium solution preparation operation is often overlooked in terms of process design and optimization, scale-up and technology transfer. Collaboration and information sharing within BioPhorum revealed that many supplier partners and biopharma companies have experienced challenges with effective medium solution preparation. BioPhorum formed a cross-industry team to leverage collective knowledge and experience to stimulate greater focus and develop best practices to the benefit of the industry.
Specifically, this best practice guide focuses on key considerations and recommendations related to medium formulation and components, process and equipment design, scale-up and technology transfer, medium preparation process controls and measurements. Case studies are also provided. Although focused on chemically defined media, key considerations and recommendations may be applicable to complex biologic media, e.g. hydrolysates.