The new offering from the Swedish CDMO includes method development, method validation, and stability programme design and implementation
Photo as seen on company website
Recipharm, the Swedish CDMO, has launched Recipharm Analytical Solutions, a stand-alone service to support pharmaceutical companies with their Quality Control (QC) and analytical requirements. The new offering made its debut at CPhI Worldwide 2019.
The Recipharm Analytical Solutions business unit provides analytical services including method development, method validation, and stability programme design and implementation.
Recipharm said the offering includes specialist expertise in analytical techniques including in vitro permeation testing/in vitro release testing methods (IVPT/IVRT), performance testing of inhalation products and extractables and leachables (E&L). Customers can access the service via various contracts, ranging from individual projects to fully dedicated laboratories.
The offering leverages Recipharm’s vast experience and the scale of its laboratories to offer additional capacity to QC and analytical laboratories facing resource challenges while also aiming to reduce timelines and costs.
Recipharm Analytical Solutions launches as the company opens a brand-new analytical chemistry laboratory and additional stability walk-in chambers at its facility in Bengaluru, India.
This laboratory in Bengaluru, the 9th addition to Recipharm’s overall global analytical solutions offering, was commissioned in response to customer demand and became operational in October.
Commenting on the announcement, Dr Ramesh Jagadeesan, Director of Analytical Development at Recipharm said: “Reducing time to market is a key consideration throughout every stage of drug development. By taking an innovative approach to analytical chemistry and using our expertise and capacity, we can improve efficiencies and reduce vital timelines for our customers."
Recipharm employes more than 160 analytical scientists worldwide, who can perform analyses in parallel, share experience of all sorts of molecules and formulations and have the time to focus on finding solutions to customer challenges.
“Many customers place their full stability programmes with us, thus offloading their own QC labs, giving them capacity to focus on core activities," Jagadeesan said.
For Jagadeesan, Recipharm's understanding of the entire drug development and manufacturing process delivers many benefits, including the ability to develop robust methods made for the stream-lined conditions within QC labs.
"We are used to working closely with formulation development teams with regulatory implications in mind. We also understand the logistics involved in the scale-up and tech transfer of a drug product, meaning transferring analytical methods should never be an issue,” he said.
For pharmaceutical companies located outside the EU who are looking to export into the market, Recipharm offers an analytical service as well as a quality release service, also known as EU gateway release.