Plant will be fully operational by July
TriLink BioTechnologies, a US manufacturer of oligonucleotides, nucleoside triphosphates and mRNA, says its new 2,000ft2 diagnostic and pharmaceutical GMP production facility will be fully operational by July.
The San Diego, California-based facility will include validated ISO Class 7 and ISO Class 8 cleanrooms, designed to facilitate fast turnaround of IND-enabling tox and Phase 0/I GMP material.
TriLink says the facility has been built to meet growing demand for therapeutic grade GMP mRNA. However, it is fully equipped to manufacture all TriLink products, including long RNA, aptamers, oligonucleotides, small molecules and nucleoside triphosphates.
'Building a GMP facility was a natural expansion of our business and leveraged our well-established quality system,' said Terry Beck, SVP at TriLink.
'It was through customer's inquiries that we learned of the need for a supplier of therapeutic grade mRNA and the rest just fell into place.'
'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,' added CEO, Richard Hogrefe.
'We hope this new service provides an avenue for more nucleic acid based drugs to make it to the clinic.'