- Facility area:
- 15,700 ft2 (46,000 m2)
Research Triangle Park Analytical Development
Patheon provides analytical development services focused on accelerating the product development cycle. Analytical chemists develop and validate laboratory methodologies for your new active pharmaceutical ingredient or product, monitor its ongoing stability, and support the formulation and clinical manufacturing process all the way through commercialization.
Patheon’s in-house analytical development laboratories utilize some of the most advanced scientific equipment available.
Analytical development services include:
- Project start-up within 1 week of contract signing
- Method development and validation
- Method optimization
- Cleaning residuals development and validation
- Dissolution (Apparatus 1 and 2) and drug release profiling
- Forced degradation studies
- Method transfer
- Specification development
- Stability monitoring to ICH guidelines
PDS RTP offers analytical development services supporting pre-clinical through to registration batches which are seamlessly integrated with the global network of Patheon’s commercial manufacturing. Development activities are supported with modern analytical services at each stage. With 300 cubic feet of stability storage capacity, as well as 24/7 computer monitoring and backup, we have the capacity to accommodate phase 1, 2, 3, and commercial stability programs under ICH.
"Our goal is to provide customers with "best in class" development services which accelerate customer molecules to market efficiently. We will continue to add new technologies and value-added services to meet the development needs of our customers."
Patheon offers customers a fully integrated and seamless approach to pharmaceutical dosage form development. Our services are dedicated to finding the most rapid and cost-effective route to move your molecule from development to commercialization. From accelerated early phase development programs, to Clinical Trial Materials (CTM) supply and scale-up Patheon offers full formulation and analytical expertise for virtually all types of molecules.
Directions to Kit Creek as follows:
From the airport (RDU) and points east:
Take Interstate 40 west to Exit 283 A (540W). Follow 540W approximately 2 miles to Exit 67 (Davis Drive). As the exit ramp expands to 3 lanes, get in the center lane. Proceed across Davis Drive at the traffic light and take the 2nd right into Alexandria Innovation Center. We are in Building 7030.
From points west:
Take Interstate 40 east to Exit 280 (Davis Drive). Go left onto Davis Drive at the end of the exit ramp. Follow Davis approximately 3.5 miles to a traffic light with Kit Creek Road (on right) and 540 onramp (on left). Cisco will be on the corner. Turn right onto Kit Creek Road and take the 2nd right into Alexandria Innovation Center. We are in Building 7030.