The Sacramento, California facility, key to Thermogenesis’ CDMO plan, will start welcoming customers by the end of the year.
Thermogenesis, a medical device company specialised in base cell banking and cell therapy technology, is getting closer to becoming a full contract development and manufacturing organization (CDMO).
“Our priority,” said Chris Xu, CEO, during a Q2 earnings conference call, “is to provide customers with solutions that optimize the supply chain, increasing manufacture, and manage overall risk.”
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The stepping stone to achieving this result is closely linked to the opening of the 35,000 square-foot facility in Sacramento leased by the company back in 2022 and set to open by the end of the year.
Xu confirmed his company might have customers moving into the facility as early as the end of the third quarter or very early fourth quarter: “We have completed a majority of the infrastructure buildout and what’s remaining is just to have the facilities certified for ISO.”
The Sacramento facility
The facility will offer “high-quality development and manufacturing capacities as well as cell and tissue processing development quality system, regulatory compliance, and other cell manufacturer solutions for clients with therapeutic candidates in different stage of development,” according to Xu.
It will be designed into twelve small GMP units, with individual personalized cell and gene therapies being produced in each unit, allowing quick turnover for each product.
Cutting time and costs is key to Thermogenesis’ plans, with the proprietary CMC solution for the development of CAR-T and CAR-NK programs – CAR-TXpress – playing an important role to, potentially “cut manufacturing costs associated with CAR-T and other cell gene therapies by up to 50%.”
According to the company, the cost of running the GMP suites will be picked up by the customers.
“We run 12 GMP units, and each unit average 500 square feet,” said Xu. “For that 500 square feet, the average market cost […] is about $75,000 to $150,000 per month.”