We’re proud to announce that our brand new CMC facility at the Exemplify site of Symeres in New Jersey has been successfully completed. GMP drug product R&D facilities that will allow it to provide end-to-end services ranging from GMP and non-GMP drug product development to phase 1 and 2 clinical supplies of various oral, parenteral, and topical formulation dosage forms.
In addition to the existing end-to-end CMC services, such as; process chemistry; analytical chemistry; drug substance manufacturing under GMP; CMC project management; preparation of CMC regulatory chapters (IND, IMPD etc); QA oversight and sign off, our Cranbury NJ site can now help our clients with:
- Preclinical and Tox formulation
- Lab-scale formulation development
- Clinical supply solutions
- Enhancing bioavailability
- 505(b)(2) development
- Complex generic development
- Formulation and process optimization
- Technology transfer, validation, and manufacturing process excellence
With the launch of our new facility, we are now better equipped than ever to provide our clients with a comprehensive range of formulation services, from early-stage development to clinical supply.
Additional Orbitrap for our Admescope early ADME team
Also part of our strategy from the beginning of this year is the additional LC-Orbitrap instrument that the early ADME team in Nijmegen has acquired. The new Thermo Scientific Vanquish UHPLC coupled to Exploris MX mass spectrometer brings the advantages of improved mass resolution (up to 180,000), enabling high-quality HRMS services. Furthermore, it offers additional capacity to increase our sample throughput in various other assays, such as microsomal stability and plasma stability. With the added capacity, the turnaround time for individual samples has shortened significantly, enabling the team to provide clients with high-quality results faster.