Animal cell cultures

Animal cell culture technology has advanced significantly during the last few decades and is now generally considered to be a reliable, robust and relatively mature technology. A range of biotherapeutics is currently synthesized using cell culture methods in large-scale manufacturing facilities that produce products for both commercial use and clinical studies.

Using mammalian cell cultures, proteins can be produced in their effective form (quarternary structure). And, compared with microbial production in bacteria and yeasts, downstream processing is significantly reduced. In addition, infection risks in the production of human proteins can be avoided.

The robust implementation of mammalian cell technology requires a number of key variables to be optimized, including the culture media and bioreactor conditions, appropriate cell lines (CHO, BHK, hybrid and insect cells), low operating costs, high productivity rates, efficient process control and, above all, quality.

Successful implementation also requires appropriate strategies for process development, scale-up and characterization, and the validation of robust procedures that comply with current regulations.