The State Service for Medicines and Drug Control has suspended the license of the laboratory of the Marzeyev Institute of Public Health.
“Given the systematic nature of the identified violations, the validity of the certificate of industry certification issued to the laboratory is suspended until the elimination of remarks,” – reported on the website of the State Service for Medicines and Drug Control.
The State Service noted that the certificate was suspended following the results of the survey of the general level of compliance of the laboratory with the criteria of sectoral attestation on the organization of laboratory control of medicines, conducted on July 18-19.
According to the service, the survey “identified non-compliances that relate to the quality management system, equipment and drug testing.”
“The main findings indicate that numerous data integrity violations call into question the results of quality control of medicines that were checked during the survey. It has been established that studies were conducted according to methods that are not reflected in the quality control methods approved in Ukraine,” the State Service reports.
In addition, the State Service noted that the laboratory did not inform the State Service, in particular, about the lack of resources for conducting research and failure to agree on subcontracting, violation of handling of samples of medicines.
Goslexluzhba also emphasizes that at present, apart from the laboratory of the Marzeyev Institute, two other laboratories have WHO prequalification: the Central Laboratory of Goslexluzhba and the laboratory of pharmanalysis of the State Enterprise “State Expert Center (SEC) of the Ministry of Health”. In addition, the State Enterprise “Central Laboratory for Quality Analysis of Medicines and Medical Products” is accredited by the European Directorate for Quality of Medicines (EDQM) and is part of the pan-European network of laboratories OMCL.
As reported earlier, the laboratory of the Marzeyev Institute of Public Health appealed to Ukrainian President Volodymyr Zelenskyy and Prime Minister, the leadership of the Security Service of Ukraine (SBU) and the Health Ministry with a request to prevent the transfer of the market of laboratory control of medicines into private hands. The laboratory stressed that “state control of the quality of medicines is being transferred into the hands of private business, with the State Service for Medicinal Products using for its own purposes the private authorized laboratory Dobrobut-Likilab LLC, created for itself”.
As previously reported, the laboratory of the Institute of Public Health named after Marzeyev asked Ukrainian President Volodymyr Marzeyev. Marzeyev asks the President of Ukraine Volodymyr Zelensky, the Prime Minister, the leadership of the Security Service of Ukraine (SBU) and the Ministry of Health to prevent the transfer of the market of laboratory control of medicines into private hands.
Natalia Ostanina, head of the laboratory of the Marzeyev Institute, believes that the management of the State Research Laboratory of Public Health is forcing the laboratory out of the market of quality control of medicines by transferring the directions for quality control from the State Research Laboratory of Public Health to the private laboratory Dobrobut Likilab LLC.
The State Research Laboratory for Quality Control of Medicines of the Marzeyev Institute of Drugs of the National Academy of Medical Sciences of Ukraine was established in 1996, it employs four doctors of sciences, 10 candidates of sciences and 30 researchers. It is accredited by the National Accreditation Agency of Ukraine in accordance with the requirements of DSTU EN ISO/IEC 17025:2019 (EN ISO/IEC 17025:2017, IDT; ISO/IEC 17025:2017 IDT), certified by Gosleksluzhba, Quality Management System is certified by the Ukrainian Medical Certification Center for compliance with the requirements of DSTU EN ISO 9001:2018. The laboratory is the only one among scientific state institutions to be prequalified by WHO for the right to conduct quality control of medicines.
Synevo Medical Laboratory has modernized its laboratory in Dnipro, increasing its capacity by 20%.
According to the press release of Synevo, within the framework of modernization in the laboratory a diagnostic platform Cobas Pure from Roche Diagnostics (Switzerland) was installed, which is capable of performing 230 types of biochemical analyses at a rate of up to 870 tests per hour.
As a result of the upgrade, the total throughput capacity of bio/immunoassay analyzers in Dnipro will be 5,270 tests per hour.
“The capacity of the laboratory allows to qualitatively and quickly meet the demand of customers from the eastern and central regions of the country. Today this is a super-important task, as the work of the Synevo laboratory in Kharkov was suspended for security reasons, which significantly increased the load on the Dnipro laboratory of the company,” the press release emphasizes.
In general, thanks to the expansion of the analyzer base, the laboratory of Synevo in Dnipro can now perform 20% more tests of biochemical group (e.g. liver tests, kidney tests and others), electrolytes, as well as immunochemical group (e.g. thyroid hormones, reproductive panel, prenatal diagnostics, etc.).
“Synevo Ukraine” (Synevo Ukraine) is the largest network in Ukraine with 317 laboratory centers, seven laboratories (in Kiev, Lviv, Chernivtsi, Vinnitsa, Odessa, Kherson and Dnipro) and more than 1800 employees in 13 countries. The capacity of the network is more than 800 types of testing, annually serving about 4 million customers, performing more than 15.8 million tests. It is part of Medicover, a leading international healthcare and diagnostic services company.
Synevo International Laboratory Network (Synevo) is present in 10 European countries, with laboratories in Germany, Poland, Romania, Turkey, Georgia, Moldova, Bulgaria, Serbia, Bosnia and Herzegovina.
In 2017, Synevo Ukraine as part of Medicover was listed on Nasdaq (Stockholm), becoming the first and only medical company in Ukraine to carry out an IPO.
CSD LAB medical laboratory is opening partner laboratory offices in the front-line regions of Ukraine.
The company told Interfax-Ukraine news agency that, in particular, CSD LAB is opening laboratories on their basis together with medical centers.
“We opened partner laboratory offices in the frontline regions of Slavyansk, Kramatorsk and Konstantinovka (Donetsk region),” the company specified.
CSD LAB reported that the company opened more than 15 lab offices together with partners during the war, including three in Ternopil, offices in Dnipro, Khmelnytsky, Drohobych, Kamyanets-Podilsky, Ivano-Frankivsk, Lutsk, Chernivtsi, Chernomorsk, Slavyansk, Kramatorsk and Konstantinivka.
Currently there are over 70 laboratory offices and biomaterial collection points in the network all over Ukraine.
CSD LAB – one of the leading laboratories in Ukraine, provides more than 1500 tests – from general blood analysis to determination of genetic disorders in the tumor by NGS method. For 12 years CSD LAB has been one of the largest pathomorphological laboratories in Eastern Europe.
CSD LAB unites six laboratories: pathomorphology, cytomorphology, oncohematology, microbiology, clinical diagnostic laboratory and molecular genetics center. Every year it conducts more than 1.5 million tests.
Production facilities and modern high-tech equipment are located in Kiev and Lviv on a total area of more than 5 thousand square meters, as well as in Moldova and Georgia.
One of the world giants in the food market, Dutch-British company Unilever is going to produce next year a dairy ice cream, made from cow’s milk, grown in a laboratory.
Next summer, supermarket shelves may be stocked with ice cream “made from cow’s milk without cows. It will be made from milk protein obtained by fermentation, which uses yeast and fungi, among other ingredients, to grow it in vats.
However, natural cow’s milk contains many types of protein, so producing it in the lab with a satisfactory result that allows the product to be used in the same way as “classic” milk is no easy task.
A number of startups have already submitted several prototypes of “lab milk” for consideration by Unilever. The company hopes to commercialize next year a new ice cream under one of its world-famous brands – Ben & Jerry’s, Miko, Magnum, but has not yet specified which one it will choose for the debut.
Unilever explains its idea as the aim to produce the product with less greenhouse gas emissions, particularly methane, which is inevitable in dairy farming, subject to the profitability of the new technology.
However, Unilever is not the first company in the food market, trying to introduce “milk without a cow. Last year, American Starbucks already tried to sell products based on “lab milk” produced by the startup Perfect Day in its cafes in the Seattle area.
In March-April 2022, the Synevo laboratory paid UAH 35 million in taxes and fees to the budget, commercial director of the Synevo laboratory Mykola Skavronsky said.
“For March and April 2022, the Synevo company still paid about UAH 35 million in taxes and fees to the state,” he wrote on his Facebook page.
Skavronsky also said that in March and April 2022, the Synevo laboratory paid UAH 67 million to its employees “1.5 times more money than the entire revenue for these two months”, the total cash receipts of Synevo during this time amounted to UAH 47 million.
“Financial support for our employees in the first months of the war was provided exclusively at the expense of Synevo’s own reserves,” Skavronsky wrote.
Synevo is the largest network of laboratories in Ukraine, part of the Swedish medical holding Medicover. The Synevo network includes 320 laboratory centers operating in 125 settlements of Ukraine, as well as eight laboratories that perform more than 1,000 types of tests.
Every year, the company’s laboratory centers serve more than 4 million customers.
A laboratory for the production of diagnostic test systems was opened in the territory of Ecopolis HTZ business park in Kharkiv on June 24.
According to the press service of Kharkiv City Council, the opening ceremony was attended by secretary of the city council Ihor Terekhov, president of DCH Group, which includes Ecopolis HTZ, Oleksandr Yaroslavsky and chief sanitary doctor of Ukraine Ihor Kuzin.
“I am sure that these test systems will be in demand all over the world. And it is great that young people, our students, who will be able to practice here, mastering new technologies, will work here. We want to ensure that the best specialists stayed in our country,” the press service quotes Terekhov.
According to Yaroslavsky, $ 2 million was invested in the laboratory. It will be engaged in the development and production of molecular biological diagnostic test systems, in particular, PCR tests for the detection of COVID-19, including the new Delta strain, PCR tests for influenza, and in the long term – for cancer.
The next stage in the formation of Ecopolis HTZ, according to Yaroslavsky, will be the presentation of a Kharkiv-made tram, which is scheduled for autumn.
As reported, Ecopolis HTZ business park is a long-term investment project of Oleksandr Yaroslavsky’s DCH Group. It is being created on the basis of Kharkiv Tractor Plant, and the plant itself will become an anchor resident of the industrial cluster.
