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Kamada is engaged in the research and development of specialty pharmaceuticals by means of an advanced, patent-protected technology based on chromatographic separation techniques. Kamada’s research and development is carried out by highly qualified and experienced researchers who are engaged in the development of new products and in improving and developing manufacturing processes. Kamada’s research division, its proprietary know-how, state-of-the-art equipment, and human resources all distinguish Kamada’s R&D Department in terms of capabilities and added value to the company’s products and strategic partnerships.
Kamada currently has several collaborations on R&D programs with companies and organizations in Israel and worldwide. These partnerships combine the company’s unique R&D capabilities with those of its partners with the aim of developing and manufacturing new bio-pharmaceutical products and improving existing manufacturing processes.
Kamada constantly aspires to expand its R&D activities and exploit its capabilities both in the purification of proteins from different sources, and in development of the company’s chromatography technology and adapting it to process a wide range of different raw materials.
A growing number of pharmaceutical clients are taking advantage of Kamada’s sterile filling services, which is carried out in Class 100 clean-rooms. The company’s aseptic filling facility, which has been fully validated by the US authorities and the Israel Ministry of Health, is capable of filling 0.5 to 50 ml vials with different kinds of sterile solutions for a range of different uses, from clinical trials to products for marketing in a variety of markets, including the U.S. market.
Kamada possesses the know-how and facilities required for the preparation of formulations of pharmaceutical products, from the raw material stage to the final formulation stage. The formulation process is carried out in compliance with stringent cGMP regulations for pharmaceutics and in accordance with the highest quality and safety levels that typify the company.
Kamada possesses the know-how, patents, and longstanding experience in the field of protein separation using advanced chromatography methods. Chromatography is based on differences in the chemical and physical properties of the raw material’s components, and requires skill and expertise with regard to the conditions and ways it is carried out in order to achieve the required final product. The technology, which has been approved by the U.S. FDA and the Israel Ministry of Health, was developed at Kamada and implemented in its manufacturing facility, enables the company to manufacture stable, stabilizer- and preservative-free drugs in liquid form with extremely high purity levels.
In addition to using the technology to manufacture its own products, Kamada also allows partners and stakeholders to hire its services for protein purification and the manufacture of products that are free of foreign proteins and other contaminants.
Kamada’s manufacturing facility is used to manufacture and fill drugs for human use. The facility, which is approved by the U.S. FDA and the Israel Ministry of Health, complies with the stringent standards of cGMP for pharmaceutics. The facility has also been audited by the European Medicines Agency (EMA).
A drug’s research and development process culminates in its registration with the competent health authority (e.g., the Israel Ministry of Health and the U.S. FDA). In order to register a drug and receive a marketing license, the company has to submit a dossier to the health authority.
The dossier contains data on the chemical composition of the drug, the manufacturing processes, the quality indices, and the various tests and experiments (in the laboratory, in animals, and in humans) performed with the drug, demonstrating its safety and efficacy. The data is rigorously scrutinized by the health authority, and the manufacturing facilities and laboratories undergo a meticulous audit. At the end of the process the authority approves the drug and grants a marketing license.
Kamada has a dedicated regulatory affairs department staffed by highly skilled and experienced personnel. The team includes managers with extensive proven experience in the development and registration of drugs in many countries, where the company operates.
Kamada is a fully-integrated pharmaceutical company, and as such, has established worldwide marketing and distribution networks. Kamada currently runs an extensive marketing network of partners and distributors in more than 20 countries. Kamada’s marketing and distribution capabilities are manifested not only in partnerships with local partners and distributors, but also in an in-depth familiarity with the market, marketing methods, tender systems, and local competitors.
Kamada also possesses knowledge and experience in registering drugs with the FDA, EMA, the Israel Ministry of Health as well as with various regulatory agents worldwide. Kamada’s registration team has extensive experience in registering the company’s products in many countries around the world, and has been doing so for more than twenty five years.
In Israel, Kamada is active both in the institutional and private markets. Besides marketing the drugs that the company manufactures in its own facilities, the company has long-term agreements with international manufacturers for the marketing and distribution of their products in Israel. These agreements enable Kamada to complement its product line both in terms of types of treatment and the range of products offered, thus contributing to the well-being and health of patients in Israel.