R&D and Facilities
R&D and Production Facilities
We have two R&D facilities (Israel, China) and GMP manufacturing facilities for both API in Neot Hovav IL and Finished Dosage Form (FDF) in Jerusalem IL.
We have two research and development facilities for complex APIs and formulations in Israel and China. The two R&D sites (Ness Ziona, Israel and Nanjing, China) are engaged in various aspects of our chemistry and pharmaceutical development. The Israeli site is focused on novel process research & development for our highly complex APIs, as well as laboratory “proof of concept” development and pilot-scale pharmaceutical development. Our technical teams have experience in optimizing existing processes and developing new or second generation safe and environmentally sound routes.
Our late-stage development team has extensive experience in the following: commercial synthesis route scouting, commercial process development and optimization through Design of Experiments and Quality by Design for the pharmaceutical products portfolio via defining critical process parameters and impurity profiling. Our Chinese facility is focused on kilo-lab scale production of advanced intermediates for the pilot scale production. Integrating the two facilities eliminates the need for tech transfers when a project advances through each development phase, allowing us to reduce time to market while providing consistent and cost-effective APIs. In addition to our complex API development arm, we are engaged in the development of complex dosage forms, mainly parenterals and orals. The parenteral route of delivery includes our once-monthly depot formulation of Glatiramer Acetate and the oral route includes our existing pipeline of complex value added generics.
Production Facility - Jerusalem, Israel
Production Facility - Neot Hovav, Israel
R&D Facility - Ness Ziona, Israel
R&D Facility - Nanjing, China
Israel Development & Manufacturing Plant
Our API plant in the Neot Hovav industrial park, in Israel, is a GMP and ISO 14,001 approved chemical synthesis facility, designed for the production of APIs and intermediates. The plant is designed as a multipurpose facility with mid-size industrial production reactors of varying capacities of up to 4,000 liters. The plant’s scalable design will enable us to expand capacity with limited expenditures. The plant holds pilot facilities for smaller scale production to support the production scale-up process and initial sales.
Environmental protection is an important goal for Mapi Pharma, and one that is shared by management and employees. The Company complies with its own standard operating procedures (SOPs) and with the environmental regulations put in place by the authorities in Israel, including the Israel Ministry of Health and the Ministry of Environmental Protection as well as with the Israeli standard of Environmental Management. The company also complies with ISO14001 (2015), an international standard that specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance.
Our Company’s management and employees are required to comply with GMP principles. This includes reducing by-products, by reducing air pollution, treating waste water and minimizing waste volume. Mapi Pharma promotes environmental values within the Company, proactively acting to integrate/embrace these values among management and employees.