• ​Ensuring Product Safety and Efficacy: Regulatory agencies like the FDA and EMA mandate extensive characterization of biologics to guarantee product safety and efficacy. A thoroughly characterized cell bank forms the foundation for consistent and reliable production.
• Maintaining Reproducibility: Consistent cell characteristics are vital for reproducible research outcomes and reliable biopharmaceutical manufacturing. Our testing ensures the stability of your cell banks over time.

​

Test of Identity:

✔ 16S rRNA Sequencing (full length with phylogeny): This gold-standard method provides accurate bacterial identification down to the species level by analyzing the highly conserved 16S rRNA gene. We perform full-length sequencing and phylogenetic analysis to determine the evolutionary relationships and nearest matches to known organisms in international databases.

✔ E. coli strain Identity Testing: Specifically for Escherichia coli, we utilize 16S sequence reference-based alignment and API 20E biochemical profiling for precise identification.

Test of Purity:

✔ Bacterial and fungal impurity: We employ a culture-based approach using four different media and incubation up to 15 days to detect a broad range of potential bacterial and fungal contaminants. We also check for the presence of antibiotics or agents that inhibit the growth of other microbes.

✔ Bacteriophage detection: We test for the presence or absence of both lytic and lysogenic bacteriophages using positive and negative control cultures to ensure the integrity of your cell bank.

Test of Stability:

✔ Copy number determination by real-time PCR method: We isolate total DNA and perform quality control. Utilizing primer synthesis for recombinant and reference genes (e.g., dxs in E. coli), we construct standard curves and assess linearity and extraction efficiency. SYBR Green Real-time qPCR is used to estimate the absolute transgene copy number. Testing is performed on three vials.

✔ Restriction endonuclease analysis: This technique helps to verify the integrity and expected structure of the genetic material in the cell bank.

✔ Retention of selectable marker: We determine plasmid stability by assessing the retention of the selectable marker on both selective and non-selective media.

✔ Retention of recombinant construct: We evaluate the stability of the recombinant construct over three subcultures, followed by DNA sequencing of the Open Reading Frame (ORF) to ensure sequence integrity.

Test of Viability:

✔ Determination of viable organisms by enumeration (CFU assay/colony counting): This standard microbiological technique quantifies the number of living cells in the cell bank.

✔ MTT assay: This colorimetric assay measures cellular metabolic activity, providing another measure of cell viability and health.