Raw Materials

Raw materials in bioproduction are the essential components and substances used in the manufacturing process of biological products, such as vaccines, monoclonal antibodies, and recombinant proteins. These materials are crucial to cultivate and maintain living cells, which produce the desired biologic products through complex biochemical processes.

Raw materials encompass many different types such as cell culture media, buffers and reagents, gases, water for injection, growth factors and cytokines, antibiotics and antifungal, purification material, single use systems and bioreactor. In few words, anything that could enter in contact with the cells or the product itself.

The quality of raw materials directly impacts the quality and consistency of the final biologic product. Variability in raw materials can lead to inconsistencies in cell growth, product yield, and purity.

Ensuring that raw materials are free from contaminants, such as endotoxins, mycoplasma, and other pathogens, is critical for the safety of the biologic product. Regulatory agencies require rigorous testing and certification of raw materials to ensure their safety.

Among these raw materials, and particularly with regards to cell culture media , it is necessary to pay attention to ingredients from animal origin such as foetal bovine serum, human serum albumin or porcine derived trypsin by looking at the presence of specific viruses and bacteria.