Custom Synthesis & Contract Services
Concept to Clinic
Targeted API Synthesis
At Archer’s Custom Synthesis Division we assist companies in the synthesis of small molecule APIs by providing fully integrated cGMP manufacturing services that are fast-track, regulatory compliant and cost-effective.
Archer’s Custom Synthesis Division is focused on providing services for drug discovery, process research, development and early clinical manufacturing of pharmaceutical drug substances. Archer laboratories have been designed specifically to produce bulk Active Pharmaceutical Ingredient suitable for use in preclinical toxicology, large clinical trials and finished products. Our scientists specialize in complex organic synthesis and possess experience in both industrial and academic environments. With an extensive experience and a solid academic background, Archer has a broad range of synthetic organic chemistry capabilities, along with the knowledge of the latest techniques and technologies.
cGMP Manufacture for pre-clinical and clinical APIs • Gram to kilogram synthesis, both cGMP and non-GMP • Manufacture of APIs using protocols supplied by our customers or through synthetic routes designed to suit our customer’s needs • Process optimization
At Archer, we have an extensive array of instrumentation ranging from a 500 MHz NMR to LC-MS instruments, that suit a wide variety of needs. Our capabilities include pharmacokinetic studies, small molecule identification, protein and peptide sequencing and identification of extractables and leachables. We work with our clients from basic method development through cGLP-controlled assays to deliver cost-effective, high quality data.
• Pharmacokinetics • Drug metabolism • Metabolite studies • Peptide/Protein sequencing • Detergent analysis • Fatty acid composition • Di-sulfide bridge mapping • Small molecule analysis • Impurity identification • Polymer analysis • Phosphopeptide/phosphoprotein analysis • Proteomics (top-down and bottom-up) • Protein quantitation
Extensive testing is required for each stage of the manufacturing process in order to ensure product purity and integrity. Archer Quality Control offers a panel of qualified assays readily available to expedite product and process development. Archer Quality Control can also accommodate specific assays transferred from clients and can develop and qualify these assays in accordance with regulatory requirements. Assays that cannot be accommodated using Archer Quality Control equipment or those that would not be compatible with Archer Quality Control facilities are contracted to qualified outside vendors.
ICH Stability • Mass spectroscopy analysis • Nuclear Magnetic Resonance (NMR) analysis • HPLC (Assay, Purity) • Identification (FTIR, UV-vis, melting point) • Polarimetry • Dissolution • Residue on ignition • Loss on drying • Heavy metals analysis • Residual solvent analysis • Cleaning validation • Water testing