Life Science Solutions, OEM

The demand for personalized therapies is transforming the industry.

The demand for personalized therapies is transforming how biotech companies are mapping the journey from research to commercial manufacturing. Stringent quality requirements demand greater visibility and better integration of the manufacturing process. Government regulations like 21 CFR Part 11 have created a need for more secure systems with better system management, seamless digital data integration, and precision quality control.

Precisely maintain the chain of identity for each patient’s batch.

In cell and gene therapy processes, it is vital for manufacturers to precisely maintain the chain of identity (COI) for each patient's batch. COI procedures aim to ensure the traceability of each batch throughout the manufacturing process to assure every point of identity from sample retrieval to in-process manipulations, testing, and therapy delivery are correct and verified.

Together, Control Associates and Emerson have the industry expertise and experience to solve these critical challenges through implementing advanced software technologies like our Syncade manufacturing execution system (MES) that provides the accuracy, flexibility, and manufacturing stability to help ensure each patient's batch is perfect the first time.

With Syncade MES, we are able to streamline the entire cell and gene therapy manufacturing process by creating an electronic chain of identity, automating manual workflow procedures and manufacturing processes for improved quality, and creating paperless batch records for improved accuracy.