Celltrion the Global Pharmaceutical Company

Biopharmaceutical production process consists of cell culture process, purification process and fill and finish process.

• Step. 01 Cell Culture Process
  1. Preparation of cell culture media and buffer solution

  Cell culture media are nutrients essential for cell proliferation. At Celltrion, optimized media for the types and characteristics of cell lines are used and the composition and formulation ratios differ depending on the characteristics, culture method and environment. Media are as important as culture method and environment as they affect the protein productivity and quality. Buffer is a solution that is used to stabilize pH and conductivity to stably extract and purify proteins. It is one of the key factors of purification process because any changes in conditions can affect yield and product quality.

  2. Cell culture

  When cell line thawing and small-scale flask cell cultures are finished, they are gradually transferred to larger seed bioreactors as they divide and proliferate. Ultimately, cell lines produce antibodies that become raw materials for pharmaceuticals in commercial bioreactors under conditions optimized for productivity and quality.

  
• Step. 02 Purification Process
  1. Initial purification

  The initial purification process is to purify target proteins from the cell culture fluid harvested during the cell culture process. During this process, target proteins are recovered with high purity and yield through several steps of chromatography and removes viruses through virus inactivation and virus filtration.

  2. Final purification

  Final purification is the process of adjusting antibody protein concentration to a level suitable for drug substance, exchanging buffers for final formulation and filtering for the last time.

  3. Final filtration

  As the last step of drug substance production, final filtration is conducted to remove bacteria which leaves injectable buffer and high purity target proteins.

  
• Step. 03 Fill and Finish Process
  1. Drug product filling and packaging

  The goal of fill and finish process is filling and packaging target proteins into administrable forms. Therefore, it is operated in a thoroughly controlled “clean rooms”. Celltrion received the first-ever GMP approval from the FDA in the field of production of injectable products in Korea and operates the facilities within the FDA and EMA's GMP guidance.