This service portfolio expansion encompasses liquid and lyophilized development services, as well as technology transfer to cGMP manufacturing. Some of the pre-formulation and formulation capabilities include: characterizing physico-chemical properties; improving solubility; developing stability assays; target product profiling; screening buffers, pH, surfactants and stabilizers; container-closure and pre-filled syringe compatibility and selection, and ANDA product development.
This expansion of services strategically positions SGS to “rapidly and cost-effectively move a customer’s molecules from development to clinic and maintain our established level of quality control,” according to Richard Bunnell, PhD, General Manger of the Lincolnshire site. “Our services are supported by strong in- house expertise in analytical and microbiology method development and ICH real-time and accelerated stability studies.”
SGS has recruited two formulation experts to lead the division. Dr. Leu-Fen H. Lin will manage large molecule formulation development, and brings more than 20 years of industrial experience in liquid/solid protein formulation and protein chemistry. Her colleague, Sunil Potdar, is team manager heading small molecule formulation development, drawing upon nine years experience in formulation development in sterile injectables and lyophilized products as well as sterile ophthalmic solutions and technology transfer.
With 19 laboratories offering contract analytical and bioanalytical services, SGS leverages its strong global network to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the bio/pharmaceutical market, SGS also provides clinical trial management (Phase I to IV) and services encompassing clinical pharmacology studies, data management, pharmacovigilance and regulatory consultancy.
ABOUT SGS
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 70,000 employees, SGS operates a network of over 1,350 offices and laboratories around the world.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Ferdinand Dabu
Global Marketing Director
Life Science Services
SGS, 75 Passaic Avenue, Fairfield, NJ 07004, USA
Tel: +1-973-276-8463
E-mail: ferdinand.dabu@sgs.com
Website: www.sgs.com/pharmaqc
