Easy Approval
Cellca's technology platform has been developed to facilitate regulatory acceptance at every process step. Our technology has the following assets for promoting regulatory acceptance.- The proprietary vector utilizes genetic elements which are well-known to the regulatory authorities.
- CHO cell lines with a high safety profile, well recognized by the authorities.
- The history of the proprietary host cell line is documented throughout.
- Cell lines are routinely tested for mycoplasma and sterility. Viral contamination and the presence of virus-like particles are tested.
- Cell banks are free from serum and proteins.
- The culture media are free of serum, proteins, growth factors and peptones (hydrolysates).
- Media are produced by leading media vendors fulfilling all regulatory production requirements.
- All process steps, from DNA handling through to the bioreactor harvest are free of serum and peptones (hydrolysates).