Biopharmaceutical companies are reliant on a dependable supply of raw materials to ensure they can produce life-saving medicines for patients.
Raw material variability is not fully understood between suppliers and manufacturers, which impacts yield and process continuity.
There is a lack of understanding of raw material attributes, which means the regulatory approach is not optimized – making changes difficult.
The BioPhorum Raw Materials Program brings the industry together, using a strategic framework to guide collaboration.
An industry-wide collaborative response to building knowledge of these materials and their attributes, and actively working together towards new standards for critical raw material consistency will enable BioPhorum to contribute to an open-source living database available to suppliers, developers, and manufacturers giving access to the most recent, complete knowledge of raw material attributes and behavior.