Our proprietary manufacturing human cell line was developed to produce our drug products in a medium. This human cell line has the distinct characteristic of the cells multiplying faster than they die, which we refer to herein as the Immortal Cell Line. The E.C7 cell line has been validated by the FDA to produce human-grade products.
Etubics Manufacturing cell line has the following key features:
- Maximum Contamination Control. The manufacturing process takes place entirely within sterile bioreactors, enabling a high level of contamination of product control. This allows for minimal manufacturing down time and high throughput product purification.
- Increased Yield. GMP Manufacturing data has demonstrated that the E.C7 cell line can produce at quantities necessary to sustain clinical trials.
- High Scalability. To date, GMP manufactured lots indicate a high level of scalability without difficulties.
- Effective Purification Process. Etubics has developed a highly effective purification process, which further maximizes product yields.
- Master Cell Bank. We have produced a Master Cell Bank that contains a seed stock of the E.C7 cell line. This Master Cell Bank provides the starting stock for hundreds of manufacturing lots for future use.
- Human Cell Line. The Etubics products manufactured in a human E.C7 cell line lack contaminants that can result when producing products in cell lines derived from different species, insect cells, plants cell lines or chicken eggs.