Preventing Cross-Contamination – Operating Beyond cGMP

By Sharada Kolindrekar, Director of Validation and Tech Services

Innovative therapies providing more customized, patient-specific treatments are requiring pharmaceutical manufacturers to supply smaller batches of more complex, potent compounds while maintaining high quality standards. At the same time, drug sponsor companies are seeking the services of contract development and manufacturing organizations (CDMOs) for expertise intended to achieve better outcomes faster.

To best meet the needs of an ever-evolving, patient-centered healthcare model, CDMOs have designed facilities with smaller, agile manufacturing lines supported by equally agile analytical labs. On any given day, the scientists and engineers at CDMOs are testing, conducting formulation development, performing tech transfers, commissioning, and validating processes, and manufacturing multiple batches of drug product simultaneously in their facilities. There is a requirement to change over the lines rapidly involves cleaning, disinfecting, preparation, and set-up for the new product. One can easily recognize the risks for cross-contamination.