BryoTechnology

Regulatory compliance

As a fully contained, whole plant production system, BryoTechnology enjoys several regulatory benefits. A relief from Virus-/Viroid-testing (EMEA/CHMP/BWP/48316/2006) and the absence of any animal-derived compounds throughout the process are factors assuring a reliable, long-term source for APIs.

Production itself is accomplished in certified, disposable wave™-reactors. This format not only circumvents costly cleaning and validation procedures, but is above all highly available, familiar to most CMOs and accommodates easily in any standard GMP-suite.

Batch-to-batch consistency is assured by a cryo-based cell-banking system, which is currently under development. Genetic stability of clones has been proven in extensive experiments and delivers constant clone performance throughout month to even years of subculture.

Essential prerequisites for GMP-compliant production and accreditation, e.g. a moss-specific HCP-assay, are already in place or under development.