The specialists at Medsintez plant (Novouralsk, Sverdlovsk region) produced a test batch of injection pens with a drug used for in vitro fertilization (IVF). The device allows to inject the micro-doses of substance into the body to stimulate the development of eggs.
“Requirements for injecting pens that contain insulin are also relevant for the drug used in IVF. This includes the reliability and accuracy, ease of use, ease of setting the dose, and wide range of doses. While the insulin cartridge was designed for 3 mL, the cartridge of this injection pen has the capacity of 1.5 mL. Such “micro-drop” allows to make several injections in order to stimulate the development of own eggs in a patient who needs to be treated with assisted reproductive technology,” said Alexey Podkorytov, the General Director of the plant.
The new devices filled with Russian-made medicinal product will become yet another import substitution project implemented at the plant.
“Primapur, the drug in question, was developed by iVFarma, a company, and the production capacity of Medsintez allows to produce this medicine on industrial scale. So far, the drug is at the stage of clinical trials, and we manufactured a test batch of the biosimilar. The solution is intended for subcutaneous injection, and it is used with the injection pen, which is useful for self-injections and in the process of treatment,” said a representative of the plant.
According to Mikhail Polzikov, the General Director of iVFarma, the drug has successfully passed preclinical studies and phase I of clinical trials involving healthy volunteers.
“It remains to conduct the final phase, including the randomized study in IVF programs. This study takes place in three specialized human reproduction centers in Moscow and involves more than 100 couples.”