EMD Millipore, the Life Science business of Merck KGaA of Darmstadt, Germany, today announced the Company has entered into a strategic alliance with Turgut Ilaç, a leading biosimilars company based in Turkey and will provide their Provantage® End-to-End services for development and manufacturing of biologics.
EMD Millipore’s Provantage® End-to-End solution is a comprehensive suite of products and services enabling biopharmaceutical companies to accelerate progress of molecules into the clinic and toward commercialization. The turnkey package includes process development, cGMP manufacturing, facility design, equipment for pilot plant production, process and equipment training, technology transfer, equipment qualification and set-up for commercialization.
Under this multi-year agreement with Turgut Ilaç, EMD Millipore will provide process development, equipment for a pilot facility, cGMP manufacturing, facility design and ultimately, technology transfer of the manufacturing process to Turgut’s facility for commerical production. Use of an identical template in both pilot and commercial scale facilitates technology transfer.
Phase one of the agreement will focus on monoclonal antibody biosimilars for non-small cell lung carcinoma and rheumatoid arthritis, the first molecules of Turgut’s biosimilar pipeline that will be supported by EMD Millipore under this strategic relationship. Financial terms were not disclosed.
“Biosimilars represent an important new therapeutic option and many biopharmaceutical companies around the world are investing in their development and manufacture,” said Udit Batra, president and CEO, EMD Millipore. “We are excited to work with Turgut Ilaç, leveraging our end-to-end offering to help create and optimize processes and manufacturing facilities for these molecules. We look forward to helping them extend their legacy into the field of biologics and enable them to continue providing important benefits to patients in Turkey and surrounding markets.”
“Turgut Ilaç was one of the founding companies of the pharmaceutical sector in Turkey and one of the first to develop generics,” said Kaya Turgut, founder and chairman of the board, Turgut Ilaç. “Our business model has now evolved to focus on development and manufacture of industry leading biosimilars. To support this inititiative, we sought a provider with strong scientific knowledge and expertise that could provide turnkey support encompassing everything from process development to commercial production. With this relationship, we gain access to expertise and capabilities that will not only allow us to establish robust processes, but make the transfer of those processes from pilot scale to commercial facilities much easier and faster.”
Family-owned Turgut Ilaç was one of the first generic pharmaceutical companies to emerge in Turkey in 1951; their small molecule business was sold to Actavis in 2003. The Company expects to commercially manufacture biosimilars in a facility just outside Istanbul.
The Provantage® End-to-End solution delivers important benefits and addresses key challenges for biopharmaceutical companies at all stages of their life cycles in any geography, including established biopharmaceutical companies decentralizing manufacturing that need to rapidly and efficiently establish local production capabilities. With an end-to-end approach, EMD Millipore is able to facilitate and accelerate transfer of an entire process to a new location. Early-stage companies with limited manufacturing capabilities, resources and infrastructure benefit from a partner with best-in-class unit operations and the support and expertise to develop processes and production facilities.
For more information, please visit www.emdmillipore.com/provantage.