Almac has launched a new offering for the provision of [14C]-labelled Antibody Drug Conjugates (ADCs). Radiolabelling of drugs remains is effective methodology to facilitate absorption, distribution, metabolism and excretion (ADME) studies, and [14C] labelling of ADCs is becoming a critical part of their development.
Almac has integrated biology, chemistry, peptide and purification science, analytical and quality disciplines within their isotope laboratories. According to the company, the ability to deliver labelled linkers, payloads and complete the bioconjugation within one team, shortens timelines and results in a more cost effective solution to clients.
Dr. Tom Moody, head of Biocatalysis and Isotope Chemistry at Almac said, “As ADCs become more prevalent in drug development, our isotope expertise and technology has kept pace with our customers’ needs. Almac is in the unique position for the provision of all the services required to manufacture [14C] labelled ADCs and this can make a real difference to First in Human study programs.”
Dr. William Watters, Almac’s Isotope Manager added, “The merging of our Biocatalysis and Isotope Chemistry groups, coupled with the presence of an experienced Peptide Synthesis team, ensures that we have the right technical mix to successfully deliver on these complex projects.”
Almac has experience in the synthesis of [14C] labelled small molecules, peptides, linkers, and ADCs to both non-GMP and cGMP standards. Almac received a license by the MHRA in 2009 for the manufacture of [14C] radiolabelled drug product.