The CBC has a number of existing process platforms that have been developed both to satisfy regulatory requirements and have the potential for scale up to full manufacture

If required, we can develop and validate your process to ensure a smooth technology transfer into GMP production at the CBC.

This would include:

• A design history file providing auditable documentation of the history of the process development.

• A process designed to ensure aseptic integrity.

• A process designed for full scale-up to full manufacture.

• A validation master plan reviewed and approved by our Qualified Person

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