Teva CFS Book English

22 “ I remember sitting across from someone who went by the nickname Horrible Ron from the FDA regarding Copaxone and I logically explained to him that there were things that didn’t work, and so we did other things. It turned out that the authorities also like “good science” and respect it. Only those who dare, succeed; And we undoubtedly were daring and paved the way ” [Dr. Miki Zaife]. Copaxone paves the way for a new plant in Kfar Saba The Sterile Plant was built in Kfar Saba in 1995 with 40 workers. The plant was built as a solution to the need to manufacture the drug Copaxone - Teva’s flagship product, to treat Multiple Sclerosis (see frame on left). Dr. Miki Zaife, who served as an R&D researcher between 1983 and 2000: “I am the first person at Teva who obtained Copaxone in the mid eighties. The Weizmann Institute and Bio Yeda company it owned, were looking for an entity that understood the freeze drying process (lyophilization) since it was the technology used to manufacture Copaxone in its initial formulation. The people at the Weizmann Institute offered Teva to be a subcontractor of the lyophilization process and to fill the drug in vials. This is how we started supplying the drug that was called then Cop1 to Prof. Bornstein - the only person that was authorized to conduct clinical trials with it”. After signing the agreement, Teva introduced changes to the drug that were meant to improve its stability, its ease of use, and sterility. The plant turned Copaxone from a drug kept for only 3 months in freezing, to a drug kept for two years in refrigeration, and instead of 300 mg bottles that were divided in a non-sterile way, it was packaged in 20 mg filled syringes. Sterile product - bypasses the body’s natural defense Unlike tablets, syrups, and suspensions, sterile products are usually administered via injection, meaning they bypass the body’s defenses and therefore, they must be manufactured under strict hygienic conditions. The plant’s products are manufactured in a process that is clean of physical and microbial contaminants in clean rooms, with special characteristics, such as: control of pressure gradient, temperature and humidity parameters using control systems that alert in real time. Production workers are dressed in sterile overalls, gloves, masks, and protective goggles, in order to protect the product from contaminants originating in humans. The qualification process before entering a clean room at the Sterile Plant takes around 12 months and in order to be certified to operate a machine in the clean room you have to undergo months of additional qualification. Setting up a new plant-wide entity The first manager of the Sterile Plant was Dr. Ezra Uziel and then briefly afterwards Benny Klener replaced him. Anat Goren, who joined Production Planning at the Sterile Plant in 1995, and served as the Plant Manager between 2000 and 2007, recalls: “I remember when we started all the logistic processes associated with building the plant... “Sterile” birth - A new standard of excellence was born with the Sterile Plant The story of how the Sterile Plant was built in Kfar Saba in the nineties, is interweaved in the story of Teva’s flagship drug - Copaxone. Anat Goren