Clinical Trial Manufacturing
JHS Will Complete Your Next Clinical Trial Project with Efficiency & Control
Our commercial filling lines support clinical batches through registration and follow-on commercial production in three high-speed vial filling suites. Clinical or small-scale commercial material can be manufactured in the Clinical Trial Manufacturing area at our Spokane, WA facility for small, early-stage batch trials.
Prioritizing Expertise in All We Do
For CTM sterile-fill finish projects, we use an automatic filling process in an ISO5 environment with the ability to adjust from outside the filler barrier. Our experienced teams are prepared to discuss the scope of your next project and bring it to fruition.
Clinical Trial Manufacturing: Sterile Fill Finish
- Accommodates 2 mL to 30 mL vial sizes
- Batch sizes up to 20 L
Clinical Trial Manufacturing Lyophilization
- 30 sq ft lyophilizer
- Automatic CIP/SIP
- External condenser
- Cold shelf storage at -45°C
- Fits 4500 5 mL vials
- Manual tray loading in ISO5
- After cycle and stopper insertion, vials are put back on the filler for oversealing
Stay Up to Date with JHS
JHS Successfully and rapidly produced a clinical trial batch and three process validation batches for a client working under US Operation Warp Speed producing COVID-19 vaccines.
There are many reasons behind the success, or failure, of a technology transfer. The transferring of knowledge, experience, documents, and processes involved in developing a drug product from the sponsor to the contract manufacturing organization (CMO) is complex. But at the center of this complexity is one critical role: project management in the tech transfer.
A COVID-19 therapeutic product required a very large quantity of compounding materials to be stored under refrigerated conditions. The need was far greater than JHS’ existing capacity for cold storage given the scale of the pandemic.
Elevating Your Vision with Personalized Support
Contact us today and let’s explore how we can support your next project.