Sterile injectable production plant
Israel-based clinical-stage pharmaceutical company Mapi Pharma has announced the development of a new sterile injectable production plant in Jerusalem.
Announced in July 2019, the plant will be used for the commercial-scale production of the company’s glatiramer acetate (GA) injectable products. It will be an addition to Mapi Pharma’s existing production network in Israel, which includes an active pharmaceutical ingredient (API) facility in Neot Hovav and a quality assurance (QA) laboratory in Ness Ziona.
The facility is being developed with an investment of NIS46m ($13m). It will support the company’s future growth plans of becoming an integrated biopharmaceutical company with research and development, production and commercialisation capabilities. The company will hire 30 new employees at the new facility.
Location of Mapi Pharma’s sterile injectable production plant
The new facility will be located in the Har-Hotzvim Hi-Tech Park, Israel, on a site leased for long-term.
The company’s existing facility, which is compliant with good manufacturing practices (GMP) as per the Israeli Ministry of Health (MOH) guidelines, will also be scaled-up as part of the project. The existing facility supplies products to mid to late-stage clinical trials.
Har-Hotzvim Hi-Tech Park is one of the biggest high-technology centres in Israel. It features spacious areas, parking and a comfortable work environment. It is also well connected to Jerusalem, Modi’in and Tel Aviv.
The park is currently under development and houses several Israeli and international companies, including Intel, Omrix, and Cisco. It employs more than 9,500 people.
Details of the new sterile injectable production plant
The new facility will be a 50,000ft² plant, which was previously an FDA-approved facility operated by Omrix Biopharmaceuticals, a Johnson & Johnson company.
It will be GMP-compliant and will be equipped with a high-standard cleanroom. The products developed at the facility are planned to be exported.
Israeli Ministry of Economy granted more than NIS9m (approximately $2.5m) for the development of the facility in March. The grant is a part of the $13m investment provided by the Israeli Ministry of Economy to Mapi Pharma for the installation of equipment.
The location of the facility in the Zone A region enables Mapi Pharma to take advantage of the tax and grants.
Products to be developed at the new facility
The company’s lead investigational product candidate GA Depot will be manufactured at the facility. Mapi is developing the product in partnership with Mylan.
GA Depot is a once-monthly injection of long-acting glatiramer acetate (Copaxone®) intended for the treatment of relapsing-remitting multiple sclerosis (RRMS). The company has completed a phase two clinical trial and plans to initiate phase three clinical trial to support the submission of a marketing application to the US Food and Drug Administration (FDA).
Marketing commentary on Mapi Pharma
Mapi Pharma is focused on the development of lifecycle management (LCM) products, which include complex APIs and formulations.
The company is developing various LCM products such as Pregabalin ER, which is an oral form of Lyrica®; Risperidone LAI+ and Buspirone ER. The company holds intellectual property (IP) rights and has filed a number of patent applications for the APIs and formulations.
Mapi has a GMP-approved API manufacturing facility in the Neot Hovav industrial park, Israel. The facility is designed for the synthesis of APIs and intermediates. It is equipped with industrial production reactors, ranging up to 4,000l and also features facilities for small-scale production, supporting initial scale-up and sales.
The company also operates a research and development facility in Nanjing, China.