The Approach
Manufacturing is much more than having a suite available. We believe that manufacturing success is driven first and foremost by proper preparation. We use a systematic internal process to ensure that protocols, batch records, raw materials, logistics, and personnel are in place well in advance of healthy donor or patient cGMP batch execution.
Prepare
- Clinical scale tech transfer protocol
- Clinical scale batch record
- Bill of materials
- Project plan
Kit
- Raw material procurement
- Equipment install
- Disinfect/kit materials
- Allocate resources
Qualify
- Qualify equipment + process
- Qualify analytical methods/LIMS
- Train and certify staff
- Media fill simulation
Produce
- Engineering batches
- Health donor/patient batches
cGMP Production
Our state-of-the-art Arcadia manufacturing facility includes four (4) fully isolated 1000 ft2 ISO 7/8 validated manufacturing suites that are outfitted with biosafety cabinets and the equipment required for your process. Our production-scale equipment is matched to our process development lab to ensure seamless scaling. From pre-clinical to commercial scale, we have experience producing cells from a variety of starting materials. Our deep understanding across a range of modalities and clinical applications is what truly sets us apart, whether your working volume is 0.5 L or 100 L. Drawing upon our collective past of producing T-cells, NK cells, iPSC’s, and more, we can rapidly scale-up and release your clinical material so you can focus on your priority – providing life-changing product to the patient.
In-House Analytics
Time is of the essence with cGMP batches. Waiting for analytical test results from external laboratories leads longer deliveries of clinical material and program delays. This is why we have heavily invested in our own in-house microbiological testing capabilities. We offer raw materials, mycoplasma, and batch release testing in-house, providing a faster batch turnaround time that can save multiple days. Additionally, both standard assays and custom assay development are available.