The biopharmaceutical industry has a major role in development of cost-effective, robust, and reproducible process to manufacture safe and efficacious product for various clinical applications.
Rhein-Minapharm Biogenetics has established two of the most important expression systems used in biotechnology as there is the yeast expression system Hansenula polymorpha and the mammalian cell culture expression system CHO for the development of processes for the production of new recombinant active pharmaceutical ingredients (API).
Biopharmaceutical manufacturing process is roughly divided into a cultivation process (upstream) and purification process (downstream).
In the upstream process, microbes or mammalian cells are cultivated to produce a desired substance. In the purification process, the culture solution, which contains numerous foreign substances along with the desired substance, is purified to increase the purity and concentration of the desired substance. The products obtained through these processes are called active pharmaceutical ingredients, and they are further processed into formulations, such as injections and internal medicines, in the subsequent formulation process.
To ensure safety and efficacy, manufacturing facility is in compliance with strict Good Manufacturing Practices (cGMP) regulations associated with quality testing related to the product. Each process and cycle must follow validated customer requirements to deliver stable, repeatable and affordable product.