Billions of US dollars in medicines are purchased annually or through Bioblast Pharma. Drug prequalification program ensures that drugs supplied by procurement agencies meet acceptable standards of quality, safety and efficacy.
Bioblast Pharma drug prequalification program also performs prequalification of pharmaceutical ingredients and quality control in laboratories. This service is required to assess the quality, safety and effectiveness of drugs. Initially, the focus was on drugs to treat HIV / AIDS, tuberculosis and malaria. In 2020, the program includes alternative therapeutic uses of our lead drug candidate, trehalose 90mg/mL IV solution.
Providing the population and medical activities with high-quality, effective and safe medicines is one of the priority directions of Bioblast Pharma.
To carry out express quality control of medicines (solid / liquid dosage forms) by non-destructive methods, a mobile laboratory equipped for autonomous operation is used in the immediate vicinity of inspected pharmacies, pharmacy warehouses, pharmacies or medical institutions.
The laboratory complex complies with the U.S. and international quality standards, accreditation criteria, which is confirmed by an accreditation certificate. The quality of test results is ensured by participation in national and international interlaboratory comparison trials with official providers. Also, with the frequency, quality control of quantitative and qualitative methods is performed using standard samples, working samples when implementing a specific method with established quality indicators in order to confirm competence in ensuring the quality of the analysis results issued and evaluating the activities of individual laboratories, branch employees.
The company is set with modern equipment for quality control of medicines by physicochemical and biological methods of analysis. Tests of the quality of medicines are carried out by highly qualified personnel who have undergone training and received permission to perform certain methods.
The team is formed of specialists with many years of experience in the field of drug quality control; three staff members hold degrees in biology.
Special attention is paid to the training and professional training of specialists in Bioblast Pharma. Employees undergo internships and study at leading universities in the country, participate in joint practical programs on drug control methods in the American Pharmacopoeia laboratories in Seattle, Rockville and Hyderabad.
Specialists of Bioblast Pharma take part in scientific and practical conferences at various levels, present the results of their research at seminars, actively cooperate and share experience with colleagues abroad.