The agreement includes the cGMP sterile manufacturing of clinical materials, which Dalton will perform in its recently upgraded cGMP sterile manufacturing facility, located in Toronto, Canada. Dalton will also be performing the transfer of analytical methods and analytical release testing of the product in its Health Canada approved laboratories.
Andes Biotechnologies, based in Santiago, Chile, was founded in 2008 and is focused on developing new anti-cancer therapies utilizing the inactivation of novel non-coding mitochondrial RNA targets through antisense oligonucleotide technology.
“We found Dalton to be an excellent fit for our needs. They bring years of experience in manufacturing sterile injectable products and they have also invested significantly in optimizing their sterile facilities in the past year to meet current regulatory requirements,” said Cristián Hernández-Cuevas, chief executive officer, Andes Biotechnologies.
“Dalton is thrilled to be supporting Andes Biotechnologies with their drug development program,” said Peter Pekos, chief executive officer and president, Dalton Pharma Services. “Our team is excited to be working with Andes to advance their selective and targeted approach to treat cancer. Andes is giving hope to millions of cancer patients for a safe and effective therapy.”