A domestic knowledge-based company has produced host cell DNA (HCD) detection kits used to develop different kinds of medicines for the first time in Iran.
All biological medicines are produced in a living cell, and one of the requirements of regulatory organizations for biological medicine is that there should be nothing from the medicine-producing cell, either protein or DNA of the host cell, in the purified medicine, the news portal of Vice Presidency for Science and Technology reported.
Currently, Livogen Pharmed Company produces five dedicated HCD kits for host cell DNA detection for CHO, BHK, SP2/0, E. coli and yeast cell lines, which are the main medicine-producing hosts in the biotechnology industry.
These kits have been optimized based on the sensitive real-time PCR technique and are capable of quantitatively measuring the remaining DNA of the host cell in the medicine.
The domestic kits can compete with their foreign counterparts in terms of detection limit and lowest measurable amount.
Livogen Pharmed Company is the only manufacturer of HCD kits in Iran, which has met domestic needs for this product and reduced the import of HCD kits. It has also succeeded in producing a molecular diagnosis kit for Covid-19, which detects the N and RdRp genes specific to SARS-CoV2 in less than two hours using the Multiplex One-step RT qPCR method.
Molecular tests capable of detecting coronavirus RNA in respiratory samples by RT-PCR have been approved as the gold standard for diagnosing Covid-19 and can detect infection even in asymptomatic carriers in the early days of the virus.
Ramin Fazel, the company’s CEO, said the company is producing different kinds of molecular biology kits, viral diagnostic kits and diagnosis panels for cancer and fungal diseases.
“The company is the only producer of primers and probes in Iran,” he said.
The CEO stated that the knowledge-based company has acquired ISO9001:2015, ISO13485:2016 and ISO17025:2017 certificates, as well as the Food and Drug Organization Good Laboratory Practice license.
“The company’s products are exported to Armenia and Iraq, which buy products such as kits for CHO Extraction, DNA Ladder, Agarose and DNA Extraction,” he said.
Referring to jobs created by the company, Fazel said, “Currently, 80 people with an average age of 30 years and with a Master’s degree are working in the company.”
First Indigenous Production of Reverse Transcriptase Enzyme
A knowledge-based company has produced reverse transcriptase, a widely used multifunctional enzyme used in the field of biotechnology.
Dena Zist Asia Company has developed an enzyme used at high temperatures for reverse transcription and for the preparation of cDNA from all types of short and long molecules with simple and complex RNA structures, according to the CEO of the company.
“This and other enzymes that we have produced are used in biotechnology, as well as molecular biology and diagnostics,” Hesam Dehqani was also quoted as saying by the Vice Presidency for Science and Technology.
Since such an enzyme was not produced in Iran, the company decided to undertake its production for the first time in the country to meet domestic demand, he added.
The CEO said those who are active in the fields of molecular biotechnology and diagnostics are customers of the domestic reverse transcriptase enzyme.
Referring to the advantages of the domestic enzyme, Dehqani said the speed of cDNA synthesis by the enzyme produced in Dena Zist Asia Company is 10 minutes, which is shorter than that of its foreign counterparts.
The CEO noted that the enzyme activity temperature is above 50 degrees, which can guarantee the synthesis of cDNA from RNAs with all its structure.
“The price of providing this enzyme to the market is about one-tenth of imported enzymes, which do not have all the required characteristics, including very speedy and high temperature activity,” he said.
“The company has succeeded in making several other enzymes used in molecular biotechnology. Currently, eight specialists are working in this company, but more jobs will be created with the rise in production of enzymes used in molecular diagnosis.”
According to Dehqani, in addition to the Vice Presidency for Science and Technology, other institutions are also supporting the development of products using advanced technology.
“This is because the growth of production is possible by mastering advanced and key technical knowhow in different fields,” he said.
