Medical treatments have been using biological extracts and microbial treatments for many centuries. Gradually chemical pharmacological compositions using proteins came into the picture and then the clinical researchers started exploiting molecular genes by devising genetic engineering approach in the body cells. Since the last two decades, cells have been used as a promising therapeutic agent for treating several complex diseases. The different types of cell therapies include immune cells used for autoimmune or cancer-related therapies, as well as stem cells for regenerative medicine. But in spite of its immense potential, more research is needed to promote these therapies as standard mainstream ones due to the risk of unanticipated results in the patients.
Therefore, many institutions thoroughly use cells for research purposes to assess their therapeutic efficacy and use them for treatment. But most clinical organizations and industries lack the facilities for cell isolation and processing and therefore seek ready-made and processed cells for research or treatment purposes. For efficient research and therapy, the cells used must be developed under good manufacturing practices or GMP. Cell therapy developers and manufacturers usually use certifications of GMP for maintaining compliance with specific regulations applied by the FDA. The “GMP” classification for cell development and processing purposes is typically used to refer to the quality system that ensures that products are consistently produced and controlled according to standards for minimizing variability and related risks.
If your lab or industry is looking for procuring cells for research or treatment purposes, here are some points you can look for in order to maintain your culture regularity:
Meeting scientific requirements
When ordering cells from a supplier, one should make sure that the supplier is scientifically adept and understands the requirement. There are many naïve companies in the market with a promise to deliver cells but they lack proper facilities for development of good quality cells. Poor quality cells hamper the research and unnecessarily take up a lot of money and time. Moreover, model-specificity and tissue-specificity are very important factors that the suppliers should be aware of before delivering the cells. The responsibility lies on the supplier to determine whether the given cells are up to the mark.
While ordering cells, it is very important for the suppliers to maintain quality and consistency side by side. A suitable consistency in the quality characteristics such as marker levels and viability as well as endotoxin levels is critical for the researchers for managing scale-ups of therapeutic agents for use in case of larger cohorts. For ensuring consistency, a supplier may be asked to show 3 sets of data based on the characteristics of the cells they are delivering.
The responsibility for good quality cells resides with the supplier and good quality comes with good experience. An experienced supplier of cells will be active in sharing quality assessment details and aid you with other details needed for optimum culturing conditions of the cells. With experienced suppliers, you can always expect a quality vendor-customer relationship.
At the core of the Quality Management System is extensive documentation and record management system. The supplier should maintain GMP certifications, written procedures, manufacturing records and quality assessment certificates for the cells they deliver. The documentation ensures standard regulations and helps both the client and the supplier in maintaining qualities on both ends.
With Kosheeka, you get the guarantee of a trusted cell provider for your research and industry requirements. Kosheeka ensures that your requirement is met with the best-quality cells along with the necessary quality assessment documentations for promoting good research practice and building a partnership for future therapeutic endeavors.