Linkers for Drug Conjugates
Almac has a wealth of experience in the development and manufacture of linker technologies used in the manufacture of antibody (or protein) drug conjugates (ADC) from early phase to late phase / commercial supply. Almac’s expertise in the process and analytical development of both small and large molecules means we are uniquely positioned to deliver the best solutions for our clients. These molecules require excellence in organic / peptide chemistry, purification technology expertise, and superior analytical tools to ensure regulatory submissions proceed smoothly. We have independently developed expertise in these areas and can efficiently develop and validate required methods in-house.
Having developed and manufactured commercial products in this space further demonstrates our proven capability to support clients through to successful market launch.
Conjugation expertise
Conjugation can be achieved using a wide variety of linkages in the target molecule exploiting cysteine or lysine residues. We have proven expertise in the conjugation of peptides to a wide variety substrates and payloads. Besides the classical maleimide, disulfide, hydrazine and amide chemistries, Almac has built a strong foundation in versatile conjugation approaches such as azide-alkyne click cycloadditions, metathesis, and native chemical ligation, to name but a few.
Our GMP team has successfully produced linkers, heterodipeptide conjugates (e.g. peptide1-PEG-peptide2), or peptide-chelator constructs for radiopharmaceuticals. The Almac R&D group routinely showcase their excellence in the synthesis of peptides connected to proteins (BSA, Ubiquitin, KLH,…), fluorescent probes, or chelators; and synthetic chemokines and histones conjugated to various dyes.
This expertise comes with the right equipment and technologies to support manufacture: SPPS and bulk reactors, flow chemistry and enzymatic techniques to support conjugation; UF/DF for purification; complete in-house large molecule analysis capabilities.