Darnytsia Took One More Successful Step Towards mRNA Vaccine Manufacturing

Darnytsia Pharmaceutical Company took one more important step towards mRNA vaccine manufacturing.

Thus Darnytsia production facilities underwent a remote inspection organised in partnership with The Medicines Patent Pool (MPP) and Pharma-Consulting ENABLE within the framework of the global mRNA Technology Transfer Programme. The purpose of the inspection was to assess the manufacturing readiness level of Darnytsia technological facilities to local mRNA vaccine manufacturing in Ukraine.

MPP and Pharma-Consulting ENABLE inspectors came to the conclusion that laboratories, technical equipment and effectiveness of the internal processes building systems are in compliance with the best practices of the world’s leading manufacturers of biological preparations. In particular, inspectors had a high opinion of Darnytsia Quality Assurance System, the work experience of R&D teams and of the regulatory service as well as the company’s approach to building supply chains, which is a particularly challenging task amid the russian armed aggression in Ukraine. 

All of the above allows Darnytsia to come close to manufacturing the new generation of vaccines. What lies ahead is the company’s passing to the next stages of the mRNA technology transfer. We are talking about the presentation of the corporate strategy for medicinal substances or finished products manufacturing, development of a corresponding readiness plan and design of a production planning and product testing programme.

‘It is the first and, therefore, the most essential step towards ensuring the pharmaceutical independence of Ukraine. Our МРР partners are of the opinion that the Ukrainian companies have all the required competences for our country’s participation in the mRNA Technology Transfer Programme. Everything else is just a matter of resources and human potential and I am positive that it will not be a problem due to our vast crisis management experience,’ said Hanna Pavliuk-Havrylova, Head of Department of International Registration and Entry to New Markets of Darnytsia Pharmaceutical Company.