Teva CFS Book English

Creativity where it matters biological products. When the decision was made, we immediately went from thinking about Copaxone production to thinking about producing innovative products that we knew virtually nothing about. We moved to very complex processes, updated procedures, and had to be very flexible and creative in our thinking”. Since this was Teva’s future goods, a lot of thought was invested and work with the R&D unit in a condition of uncertainty, infrastructures were built, innovative and expensive raw materials were obtained from Israel and abroad (millions of dollars for a batch of raw material) and of course, relevant knowledge was attained. Reaping the biological benefits To date, Teva has approval to market two biological products that were originally developed by AMGEN- the largest biotechnology company in the world: The first was Filgrastim- the first biological product that the company launched and is manufactured in Kfar Saba and marketed to the entire world. Filgrastim is given as reinforcement to chemotherapy patients, and it acts by raising the white blood cell count. Similar to other biological preparations, this is also a protein that is found in the blood, which is where its high efficacy stems from. The second product is called Lonquex, which is an upgrade of Filgrastim, and is currently produced by a third party company in Germany and marketed to Europe. Soon, Kfar Saba will apply to manufacture and package this product. A third biological product called Reslizumab is in advanced stages of development, and one of its configurations will also be manufactured at the Kfar Saba, which is establishing its status on the biological products map. Teva’s goal was to continue establishing Kfar Saba as the flagship plant of manufacturing the biological products in addition to Copaxone. Entering the domain was a huge challenge and the pride for choosing the plant as a global leader in biological products production was great. Almost an omelet at the dress rehearsal... Anat Cohen, Section Head at the T&SA Department “Before entering production of the validation batches of Lonquex, we manufactured a batch using rejected raw material to conduct a “dress rehearsal” before the validation batch, and in order to check that we controlled the production process and to prevent future malfunctions. This is a very expensive raw material - 1.5 liters (50.72 oz.) cost around a million and a half Euro! The product’s Project Manager from Germany attended the batch production. At the compounding stage everything went smoothly and morale was high. When we moved to the filtration stage, we encountered a strange phenomenon for the first time. Even though pressure was exerted, the solution did not filter and because the pressure in the system was very high, the preparation’s solution started to foam and we saw that the color of the solution was changing from clear and colorless to white (proteins are highly sensitive to mixing and whipping and under these conditions they change their properties exactly like an egg white when it’s whipped). Needless to say, we were aghast when we saw what was happening, and all in front of the project manager from Germany... The availability of the raw materials to produce biological products is low due to their high cost and if heaven forbid there is a problem with the batch we can wait months to get new raw materials. As soon as we witnessed the spectacle, we stopped the filtration process and conducted a risk assessment on the spot, together with all the production and quality assurance managers. In accordance with the conclusions, we conducted corrective actions that proved to be effective and only then did our nerves calm”. 37