14 June 2013

Now it will be possible to make certified cellular products in Russia

"So could Angelina Jolie"

Nadezhda Markina, "Newspaper.Ru"Correspondent of "Gazeta.

Ru" visited the opening of a new laboratory complex for the production of cellular products and the provision of services in the field of regenerative medicine and medical genetics.

The successes of cellular technologies in medicine are becoming more and more impressive: specialists create bioengineered organs, use cells for the regeneration of organs and tissues. But these technologies cannot be engaged "on the knee": in order to certify a biomedical product, it had to be manufactured in compliance with international standards – GLP (Good Laboratory Practice) – good laboratory practice, GMP (Good Manufacturing Practice) – good manufacturing practice. The first laboratory and production complex in Russia, created according to GLP and GMP standards, for the production of biomedical cell products was built by the Human Stem Cell Institute (HSCI).

One of the main requirements is clean rooms. This means that they must contain a strictly defined number of suspended particles per unit volume of air. This number is determined by the cleanliness class, depending on the purpose of the premises. Cleanliness is ensured by a system of locks with a difference in pressure and separation of air flows from different objects. The total area of clean rooms of the new complex is 360 m2. All employees working in them must be dressed in overalls.

The complex includes a laboratory of cell cultures, a laboratory of molecular genetics, a pharmaceutical unit, an umbilical cord blood stem cell bank, a reproductive tissue bank (Reprobank), an automated cryopreservation designed for storing cell products in deep cold conditions (-196 ° C). All units are equipped with high-end equipment.

"The complex has two main purposes," explains Artur Isaev, Director of the ISC. – First, it was created for the production of products developed by the HSC in the field of cellular technologies and medical genetics." These include, for example, SPRS therapy, a personalized technology for skin restoration using its own fibroblasts. It is designed to correct age-related skin changes or remove scars and other defects. The technology belongs to the field of aesthetic medicine, but, emphasizes Vladimir Cherkasov, one of the leaders of the direction: "This is not a miracle of rejuvenation, this is therapy."

The specialists of the HSCC conducted clinical trials and brought the technology to the market. Fibroblasts are isolated from the patient's skin, and, as Cherkasov explains, 4 mm of skin is taken from behind the ear - in this place it is least exposed to UV rays. Cells are cultured in the laboratory and a cellular drug for injection is obtained from them. The service also includes diagnostics: depending on how the patient's cells divide and grow, they make a forecast about the behavior of cells in the body and plan the number of necessary injections. Specialists work with aesthetic medicine clinics that order drugs from them. Now this is a rather expensive service, since the process of working with cells cannot be automated. Specialists have conducted clinical trials of SPRG therapy for the restoration of periodontal soft tissues in dental practice and are developing SPRB therapy for the restoration of periodontal hard tissues.

The drug "Hemacell" from umbilical cord blood also belongs to the cellular products of HSC. "We have two protocols for this drug,– Isaev says. – One for the treatment of heart attacks, the second for the treatment of chronic liver failure. But we can't get permission from the Ministry of Health for clinical trials. This is due to attempts to introduce a new law on cellular technologies. Now there is a law on registration of medicines, and we have submitted the drug for registration several times – both as a drug and as a technology, but the Ministry of Health refuses us."

Genetic testing is carried out in the laboratory of medical genetics. For example, preimplantation genetic diagnosis before in vitro fertilization procedure. It allows, after fertilization "in vitro", to choose only healthy embryos for implantation into the uterus, in which there are no chromosomal abnormalities and mutations of various diseases in the genes. "This is a good alternative to prenatal diagnostics, when genetic testing is carried out in the fetus," says Ekaterina Pomerantseva, head of the laboratory, "since it avoids abortions."

Another technology for genetic testing of adults called "Ethnogen", about which "Newspaper.Ru" has already written, based on microchips. It is designed to detect 66 hereditary diseases and 293 mutations associated with such diseases. The unique feature of this test system is that it was created specifically for residents of Russia (the carrier of mutations differs depending on belonging to an ethnic group). The necessary DNA sections are applied to the microchip, and the presence of mutations in these areas is detected by a scanner that shines through the microchip with a laser: when one nucleotide is replaced by another, the color changes. The task of this diagnosis is to identify mutations at the stage of carriage, when they do not manifest themselves in this person, being in a heterozygous state. But if two such mutations occur during fertilization, it can lead to the birth of a sick child.

"Today there is a real chance not to pass on your gene to the next generations," Isaev says. – So could Angelina Jolie. Although, as far as the risk for her personally is concerned, she did the right thing. In general, Angelina Jolie has done more for the development of genetics than scientists have done in a decade."

The second goal of the new laboratory and production complex is to provide on a contractual basis the opportunity to produce the drug to other developers, Russian and foreign. "These premises can serve so that a researcher who does not have such conditions could come here and work out the entire technological chain," he told the newspaper.Ru" Professor of the Institute of General Genetics of the Russian Academy of Sciences Sergey Kiselyov. – And be able to produce small batches of the product that are necessary to complete preclinical studies and start clinical trials. Similar structures exist in the West and are called prototyping laboratories. Their task is to bring scientific development to a standard product. It is much more cost-effective than for each researcher to make such premises for their development, which are very expensive."

"One expert said that in 2012-2014 there will be a turning point in the development of cellular technologies when they move from the zone of expectations to the zone of practical implementation," Isaev summed up. – And this forecast is coming true. During 2012, several cellular preparations were registered, and during 2013 and 2014, several cellular preparations should be registered. But, on the other hand, it became clear that there would be no miracle when one injection would solve all the problems at once. The development of cellular technologies is a path of trial, error, analysis and trial and error again."

As far as Russia is concerned, a lot depends on the form in which the law on cellular technologies will be adopted. "Today, on the one hand, he is made "for one comb" for both simple and complex drugs, and on the other hand, some of the drugs are beyond his competence,– Artur Isaev believes. – The second problem: the law must be accompanied by by-laws that regulate specific things. If they pass a law and do not adopt by-laws, nothing will move."

Portal "Eternal youth" http://vechnayamolodost.ru14.06.2013

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