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Custom and Specialty Chemistry
The monomers, ligands, and building blocks that are not commercially available, made in the same organization that makes the molecule.
The building block as a supply risk
A modified amidite with one supplier, a six-month lead time and no Drug Master File is a single point of failure in a CMC package, and it usually becomes visible when a regulator asks where the regulatory starting material came from and what controls it.
Making the monomer where the oligonucleotide or peptide is made removes the dependency, the shipping and the second set of specifications. It also means the impurity profile of the building block and the impurity profile of the API are understood by the same people.
Nucleoside and phosphoramidite chemistry
More than 1,000 amidite molecules customized for client programs, made in plants dedicated to amidite production.
At NDA, the Drug Master File is what matters. More than 40 catalog amidites are available at commercial scale with Drug Master Files already filed — DNA, 2′-MOE, 2′-OMe, 2′-F, LNA and PMO monomers among them. Without a DMF, an amidite used as a regulatory starting material has to be documented in the sponsor’s own filing; with one, it is cited by reference number.
Behind that sits an impurity control strategy: more than 1,000 amidite impurities were synthesized deliberately, characterized and assessed for their effect on oligonucleotide API quality, which is what allows a specification to be justified.
Ligands, linkers and chelators
More than 100 GalNAc structures: mono-, tri- and tetra-GalNAc, GalNAc amidite, PFP ester, azide, and GalNAc-PEG conjugates. Batch scales run from milligrams to more than 50 kilograms, from discovery through to commercial launch.
For radionuclide work, the chelator is the critical building block. DOTA and NOTA chelation is available on both peptide and oligonucleotide sequences, made in the same place as the sequence itself. Twenty-eight of the 118 conjugates we support are radionuclide drug conjugates.
Unnatural amino acids
More than 2,500 unnatural amino acids in the catalog and more than 16,000 customized since 2019, across α-methyl and N-methyl series, protected-group series, α- and β-construction series, and NCA chemistry.
Custom synthesis runs from laboratory to production scale, because a residue available only in 50 mg quantities cannot be taken past candidate selection.
Labeled and modified residues are part of the same service. Dye and fluorescent labeling, biotinylation and isotope labeling are all available on the sequences these building blocks go into — the labeled analogue for an assay and the unlabeled material for the study come from the same chemistry.
Catalog products
More than 600 amidites and more than 2,500 unnatural amino acids are available, with specification and availability listed per product.
[ Nucleic acid catalog → ] [ Amino acid catalog → ]
Removing a dependency
For 40 of our amidites the Drug Master File is already filed, so the building block is cited by reference number rather than documented in the sponsor’s own submission.
For everything else, the monomer, the ligand or the residue is made on the same site as the molecule it goes into, by the people who hold both impurity profiles.