Grace’s Fine Chemical Manufacturing Services facility in Tyrone, Pennsylvania (CDMO) has more than 40 years of history in custom manufacturing. It offers a blend of chemistry and engineering, more than 80,000 gallons of reactor capacity, the ability to develop continuous processes, and the handling of highly hazardous materials as a CDMO.
Grace’s FCMS uses this site to manufacture registered starting materials (RSMs), and it has the capability to produce non-cGMP pharmaceutical intermediates. In fact, through the Tyrone facility, Grace’s FCMS has the unique ability to back-integrate RSMs within North America. Tyrone is particularly well equipped for complex, multi-step synthesis with various materials of construction and covering almost every unit operation available. We also have the capability to handle cryogenic reactions down to –90ºC.
Integrated domestic custom manufacture
The combination of Tyrone and South Haven custom manufacturing facilities offers U.S. companies the chance to outsource drug substances domestically and structure a simplified supply chain, mitigating the risk of going overseas to source starting materials.
This capability is further supported by the long tenures that Grace FCMS has at both sites and the way the highly experienced teams work together. South Haven provides support for quality assurance across both sites, and the quality management system at Tyrone is aligned to meet FDA and ICH requirements.
2858 Back Vail Rd.
Tyrone, PA 16686
+1 814 684 7223
- Nine chemists on site (2 Ph.D., 1 MS, 5 BS)
- Average tenure exceeding 15 years
- Fume hoods, walk-in hoods
- Glassware up to 22L
- Lab-scale wiped film evaporator (glass)
- Lab-scale high-pressure reactors (300 mL to 4 L)
- High-throughput parallel reactor system
- Glove box
- Over 80,000 gallons (300,000 L) of capacity
- Sizes range 500 to 4,500 gallons (1,900 - 17,000 L)
- Glass-lined, stainless steel and Hastelloy® alloy, nickel, zirconium
- Up to ~150 PSI
- Centrifuges, belt filters and filter presses
- Agitated filter/dryers
- Rotoform® pastillator
- Dryers (rotary, horizontal plow dryer), glass, stainless steel
- Wiped film evaporators (glass, stainless steel), 1mmHg
- Distillation columns (glass and alloy up to 20 stages)
- Solvent drying
- 30 to 500 gal (100 - 1,900 L)
- Up to ~250 PSI
- Temperatures –90ºC to 250ºC
- Agitated filter/dryers
- Dryers (rotary)
- Wiped film evaporators (glass, stainless steel)
- Numerous GCs (HP 6890, 6850, 7890), equipped with autosamplers PID, TCD Headspace
- Numerous LCs (HP 1100, 1200) equipped with autosamplers
- NMR Bruker® 400 MHz
- HPLC MS