TriLink BioTechnologies’ new facility will feature validated ISO Class 7 and ISO Class 8 clean rooms, specifically designed to facilitate fast turnaround of IND-enabling tox and Phase 0/I GMP material.
TriLink decided to build the facility to meet the growing demand for therapeutic grade GMP mRNA. However, the new facility is fully equipped to manufacture all TriLink products including long RNA, aptamers, oligonucleotides, small molecules and nucleoside triphosphates. Because TriLink’s GMP quality system is specifically designed for early phase materials the service will also be a more economical choice for customers investigating safety and efficacy.
“Building a GMP facility was a natural expansion of our business and leveraged our well-established quality system. TriLink has been at the forefront of the rapidly emerging mRNA market. It was through customer’s inquiries we learned of the need for a supplier of therapeutic grade mRNA and the rest just fell into place,” said Terry Beck, Sr. Vice President.
"Our existing quality system, agile business model and extensive nucleic acid synthesis experience place us in a prime position to provide affordable IND and Phase I materials fast," said CEO, Richard Hogrefe, Ph.D. "We hope this new service provides an avenue for more nucleic acid based drugs to make it to the clinic."