Cell bank characterization

Using advanced molecular, microbiological, and analytical techniques, our experts perform a full range of characterization studies. These services support regulatory submissions, minimize manufacturing risks, and provide confidence in the quality and safety of biosimilar and recombinant biopharmaceutical products.

Our Cell Bank Services:

Identity by PCR and Sequencing (16s and Barcoding)

Purity by Sterility, Mycoplasma and Bacteriophage Testing

Stability with Sequencing and Copy Number

Viral Safety by in-vivo, in-vitro and qPCR

PCR Method Sensitive and Validated to GMP and ICH Compliant.

Retroviral Detection by RT Assay, TEM and Infectivity

Viability and CFU

HАР/MAP Testing

Animal Test with the GMP System and FDA