Nucleic Acid Amplification Techniques (NAT) to Address Biosafety of Biological Therapies
Biosafety is of utmost concern in bio-therapeutic and vaccine manufacturing, especially because of the increasing rate of discovery of previously unrecognized viruses. Viral contamination from animal products and raw materials represents a significant–and growing– threat to biotechnology products. Importantly, additional steps to detect viral contamination need to be incorporated to ensure safety.
Now that streamlined assay validation procedures and GMP-validated Nucleic Acid Amplification Techniques (NAT) tests are readily available, these methods provide manufacturers with the confidence required in production and batch release of products. The high reproducibility and fast throughput of cutting-edge NATs reduces the amount of time needed for development, safety testing, and final marketing of novel biotechnology products.