Smithers sets up formulation unit
The new unit - SP Formulations LLC - offers a broad range of formulation services for small and large molecules in a variety of pharmaceutical dosage forms, including liquids, solids and semi-solids, according to Smithers.
The aim is to support preclinical and clinical drug development for customers in North America and Europe, “with the personalised approach of a small contract research organisation,” said Michael Hochschwender, president and CEO of The Smithers Group.
The aim is to provide a “full-service” package for preclinical and clinical drug formulations, including analytical and manufacturing support, for both the pharmaceutical and biotechnology industries.
Services on offer include pre-formulation drug characterisation, including partition coefficient determination, dissolution rate, solubility studies in various solvent systems, excipient compatibility studies and solubility optimisation.
It can also carry out degradation studies include acid, base, heat, oxidation and photostability assessments under accelerated and long-term conditions. In addition to developing customised dosage forms, the company also conducts toxicological screening, analytical chemistry and sterile fill/finish capabilities in both North America and Hungary in Europe.
SP Formulations will be based in Wareham, Massachusetts, which also serves the headquarters of two other Smithers Group companies serving the pharmaceutical sector, namely Springborn Smithers Laboratories and Synomics Pharma. Both these companies provides contract research and analytical services.
"The formulations business fits very well with the GLP analytical services provided by Synomics Pharma," Hochschwender explained. "Strategically, we are moving to offer new technology to the pharmaceutical market that we already serve." Thomas Bradshaw, former CEO and president of US CRO Ricerca Biosciences, has been appointed president of the new company. Marcel Langenauer has been named vice president of market and technology development.
SP Formulations said its quality management systems have already been inspected by authorities in both North America and Europe, meeting US Food and Drug Administration (FDA) and EU regulations.
