Almac Launches New [14C]-labelled ADCs Service Offering

11 Nov 2013
Kerry Parker
CEO

Product news

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. Almacwas also awarded a license by the MHRA in 2009 for the manufacture of [14C] radiolabelled drug product.

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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.ADME-ToxicologyADME-toxicology (ADME-Tox) studies are used in pharmacology and pharmacokinetics to assess the activity/toxicity of drugs <i>in vivo</i> or <i>in vitro</i>. Find bioassays for absorption, distribution, metabolism, and excretion of drug molecules including cytotoxicity, transporter/permeability, metabolism and activity assays as well as hepatocytes and cell lines for ADME. Find the best ADME-toxicology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.BiomarkersBiomarkers are biological markers which can be measured and evaluated to indicate a biological state. The use of biomarkers in research and diagnosis can indicate a normal or disease state or drug response of cells / tissues. Biomarkers include genetic markers, cell surface markers such as antigens, antibodies or receptors and secreted molecules such as cytokines. An assay system is required for identification of biomarkers. :Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.Cancer ResearchAlthough cancer is often referred to as a single condition, it actually consists of more than 100 different diseases. Microscopy, mass spectrometry, high throughput sequencing and flow cytometry are some of the most common techniques employed in cancer research labs.Antibody Drug ConjugatesTherapeutic AntibodiesTherapeutic antibodies are antibodies engineered for use in treating diseases. They can be designed to target specific antigens, blocking harmful interactions or modulating immune responses. Therapeutic antibodies are critical in treating conditions like cancer, autoimmune disorders, and infectious diseases. Explore the best therapeutic antibody products in our peer-reviewed product directory; compare options, check reviews, and get pricing directly from manufacturers.Isotope Labelling