Facilities & Services
Our R&D Center and pilot manufacturing facility is located at our headquarters in Cedar Park, Texas, within the Austin metropolitan area. This facility is designed to support both our R&D programs and provide our customers an array of services often needed during the pre-clinical and clinical phases of a product development program. Services we offer span lab based validation feasibility studies, analytical chemistry, product stability, process engineering, validation, GMP manufacturing and clinical supply. The Mystic Team includes engineers, scientists, technicians, management and support staff.
Our cGMP manufacturing operation includes an ISO 8/Class 100,000 cleanroom and an ISO 7/Class 10,000 cleanroom, serving as manufacturing suites for production of clinical supplies, including devices and sterile unit dose form fill seal packaging, and to support the production of clinical trial supplies for Phase I through Phase III programs. Our manufacturing assets include two all electric injection molding lines and our MVP50K Aseptic filling line which operates within a Class 100 barrier isolater.
Our facilities and services support a broad range of research and manufacturing needs for our customers and partners including product integration, custom development, cGMP clinical and commercial supply.
Our capabilities include:
- Device R&D
- Drug formulation development
- Product integration and optimization (drug in delivery system)
- Process engineering and validation
- Prototype and pilot-scale injection molding
- Small batch compounding of solutions
- Pilot-scale (up to ~100,000 liquid doses per batch) aseptic drug filling for preclinical or clinical supply
- Finished product assembly and final packaging
- Quality control testing