Challenge
A pharmaceutical company encountered significant challenges in maintaining the quality and consistency of their cell banking procedures. A particular concern was the misidentification of cell lines, posing risks to product quality and regulatory compliance.
Details
The key challenges faced by the pharmaceutical company included:
- Misidentified cell lines leading to potential product quality issues
- Lack of a centralized system for cell banking activities
- The need for superior quality starting materials in line with established quality standards
Solution
To address these challenges, the company decided to outsource the cell culture activity associated with creating a central repository for cell banking to ABS. This strategic decision provided an immediate solution to their needs. By outsourcing, the company avoided the need to build this capability in-house, which would have stretched their current personnel too thin.
The decision to outsource cell culture activities yielded several advantages:
- Elimination of misidentified cell lines through the establishment of routine cell line identification prior to cell bank production
- Centralization of cell banking activities, ensuring consistent quality standards across teams
- Alleviation of the burden on internal personnel, enabling them to focus on core pharmaceutical research and development activities
Benefits
The outsourcing of cell culture activities produced several positive outcomes:
- Eradication of misidentified cell lines, enhancing product quality and regulatory compliance
- Establishment of a centralized repository for cell banking, ensuring consistency across various teams
- Cost-effectiveness compared to building the capability in-house
- Improved resource allocation, allowing internal staff to concentrate on critical research and development efforts
By centralizing cell banking activities through outsourcing, the pharmaceutical company successfully eliminated the issue of misidentified cell lines, while also enhancing the overall quality and consistency of their starting materials. This case study underlines the value of astute decision-making and innovative solutions in the pharmaceutical sector, where adherence to stringent quality standards is paramount.
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