Ensuring Nuclease-Free Process Consumables for Biopharma Applications
This white paper explores critical contamination control strategies and advanced containment solutions to protect sensitive mRNA and gene therapies in GMP biopharmaceutical manufacturing environments.
Abstract
The rapid advancement of cell and gene therapies, particularly mRNA-based therapeutics, has created an unprecedented demand for nuclease-free manufacturing environments. Even trace amounts of DNase or RNase contamination can compromise critical materials and undermine therapeutic outcomes.
Through detailed analysis of container manufacturing processes, rigorous enzymatic testing protocols, and extensive validation procedures, the paper demonstrates how advanced technologies like PharmaTainer™ establish new standards for contamination control in GMP environments. The comprehensive analysis spans innovative manufacturing technologies and validation protocols essential for maintaining nuclease-free conditions across manufacturing scales from 10 mL to 20 L, particularly benefiting mRNA vaccine and gene therapy applications. This technical resource provides biopharma manufacturers with crucial insights into maintaining product integrity through advanced single-use container solutions.
