Almac has announced the launch of a new offering for the provision of [14C]-labelled Antibody Drug Conjugates (ADCs).
In recent years the interest in antibody drug conjugates for the targeted treatment of various cancer types has grown massively, and the need for evaluation of the pharmacokinetic profile of these ADCs is becoming more important.
Radiolabelling of drugs remains the most effective methodology to facilitate absorption, distribution, metabolism and excretion (ADME) studies, and therefore [14C] labelling of ADCs is becoming a critical part of their development.
The [14C] label is typically placed on either the active drug or the linker moiety, or can be incorporated into both.
Almac’s expertise in this area comes from the integration of biology, chemistry, peptide and purification science, analytical and quality disciplines within their isotope laboratories.
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 commented: “As ADCs become more prevalent in drug development, our isotope expertise and technology has kept pace with our customers’ needs. Almac are 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 programmes.”
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 vast experience in the synthesis of [14C] labelled small molecules, peptides, linkers, and ADCs to both non-GMP and cGMP standards.
Almac was also awarded a license by the MHRA in 2009 for the manufacture of [14C] radiolabelled drug product.