Bend, OR – Bend Research Inc. (www.bendresearch.com), a leading independent drug-formulation development and manufacturing company, announced today that it has received certification of compliance with European Union (EU) Good Manufacturing Practice (GMP) regulations.
This broad certification, which was granted by Sweden’s Medical Products Agency (MPA), covers Bend Research’s manufacture of clinical pharmaceutical supplies for human consumption and testing of those supplies at the company’s GMP facilities.
“The strategic addition of this certification—combined with new capabilities such as high-potency spray‑drying and future commercial spray‑drying—strengthens Bend Research’s position as a preferred provider for oral solubilized, modified-release, inhalation, and many other dosage forms,” said Rod Ray, Bend Research CEO.
“We knew the EU’s quality standards were stringent, but we were confident that our operations met those high standards and were eager to demonstrate that to our customers,” Ray said.
In 2012, Bend Research produced clinical supplies for 16 clients, 37 chemical compounds and 136 clinical manufacturing lots. Many of these involved the use of advanced dosage forms designed to increase the exposure of low-solubility compounds or provide modified-release delivery profiles.
Bend Research requested the voluntary inspection by the MPA and certification was granted after an audit of operations by the MPA.
The MPA GMP Certificate is recognized by all health authorities in the EU under the EU’s centralized marketing authorization procedure, as well as by authorities of other countries that recognize EU certification.
About Bend Research Inc.
For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve human health and to solve their most difficult scientific and technical problems. This success is based on the company’s ability to develop, advance, and commercialize pharmaceutical technologies, which grow from a solid base of scientific and engineering fundamental understanding.
Bend Research capabilities include formulation and dosage-form support, process development and optimization, manufacture of clinical-trial quantities of drug candidates in its GMP facilities, and advancement of promising drug candidates from conception through commercialization. Bend Research is a leader in novel formulations, including spray-dried dispersions (SDDs) and hot-melt extrusions, and modified-release, inhalation, and biotherapeutics technologies.
Bend Research has more than 280 employees based in six state-of-the-art facilities in Bend, Ore., USA.