The Importance of Quality in Cell Manufacturing

As pointed out in a recent literature review (Haleem et al., 2013) on quality in the pharmaceutical industry, there has been a growing awareness of the importance of quality throughout the pharmaceutical product development cycle. The conclusion of the review is that, while everyone agrees on the importance of quality, case studies on best practices are still in short supply. This blog is one contribution, specifically in the area of cell manufacturing.

Absorption Systems has a proprietary electronic system, CellPort Analytics®, to track and maintain the quality of our cell-based test systems. This digital quality program houses records and data for all cell lines, with each cryopreserved vial tracked by barcode. The barcode identifies the cell line, as well as all relevant information such as culture reagents and lot numbers, the parental cell line, selection agent, transfection, clone, dates of freezing and thawing, and passage number. CellPort Analytics® provides expiration alerts, and notifies when to thaw vials. The electronic database is fully searchable, and historical data can be displayed in many different ways. Biosafety cabinets are equipped with laptops to enter and save data, and backup systems are in place. As a result, human error is minimized, which helps ensure the quality and reliability of multiple cell lines.
Other best practices include:

Working with only one cell line at a time to prevent cross-contamination and misidentification.
Rigorous quality control of every cell line, to ensure consistent, reproducible performance. Drift in performance is detected by CellPort Analytics®.
Maintenance of incubators and biosafety cabinets, some of which are validated for use in Good Manufacturing Practices (GMP) studies, by qualified vendor on a regular semi-annual schedule in addition to monthly checks.
Regular maintenance and calibration of instruments such as pH meters and pipettors. Service records for equipment and instruments related to cell manufacturing are maintained in CellPort Analytics®.

Reflecting on Absorption Systems’ commitment to quality, Dr. Tina Sauerwald, Director of Cell Culture and Manufacturing, stated, “Within the Manufacturing group, we have implemented numerous checks and balances to ensure that quality is managed properly. This is done through a combination of lab practices and use of our validated software, CellPort Analytics®. The added feature of barcoding all aspects of cell culture provides safeguards to our workflow to warn against or prevent human errors.”
The pharmaceutical industry depends on quality, from bench to bedside. For Absorption Systems, CellPort Analytics® has become the focal point of how we achieve it consistently. Contact us to learn more about CellPort Analytics® and how this innovative system can support your testing needs: contact@absorption.com
Learn More about CellPort Analytics®, view our poster on: “Efficiency, Analytics, and Continuity: Using CellPort Analytics® to Streamline In Vitro Drug-Drug Interaction Studies”.