Reference material synthesis
Diagnostics companies are constantly challenged with new complex requirements for clinical chemistry, not least due to everchanging and increasingly stringent in vitro diagnostics (IVD) guidelines. For this reason, companies prefer to rely exclusively on contract synthesis companies like Endotherm Life Science Molecules to provide the necessary active ingredients and biomarkers used as reference standards for the development of diagnostic immunological and HPLC- as well as LC-MS/MS-based test systems. Our focus in this arena is on unlabeled or labeled (2H, 13C, 15N) vitamin D metabolites, active pharmaceutical ingredients (API), and natural products.
Vitamin D diagnostics
Vitamin D is gaining clinical importance in diagnostics. Endotherm owns proprietary and patented synthesis processes for the production …
Reference standards are indispensable for the development of diagnostic methods …
Endotherm Life Science Molecules has proven expertise in the synthesis of complex, chiral, natural products. These can be plant ingredients, ...
Pioneering vitamin D diagnostics require novel reference materials
Vitamin D is gaining clinical importance in diagnostics. Endotherm Life Science Molecules owns proprietary and patented synthetic methods for the production of more than 35 vitamin D analogs, conjugates, and metabolites. Research-based diagnostics companies use our experience and expertise to develop immunological or LC-MS/MS-based assays for the diagnosis of vitamin D-dependent diseases.
- Stereoselective synthesis
- Stable isotope-labeled compounds (2H- or 13C-labeled)
- Labeling at unusual molecular positions and multilabeling
- Preparation of reference materials over 20–30 synthesis steps
Reference standards for therapeutic drug monitoring
Therapeutic drug monitoring (TDM), or measuring patient blood drug levels, is particularly important for correct dosing and avoidance of overdoses of therapeutics with undesirable side effect profiles.
Research-based diagnostics companies engage Endotherm Life Science Molecules to produce (sometimes labeled) compounds to the desired specifications and quantities for use as reference materials for HPLC- or LC-MS/MS-based TDM. These substances are used in the routine analysis of already approved methods and for the development of new diagnostic methods. Take advantage of our expertise in drug synthesis for the development of new test methods:
- Stereoselective synthesis
- Stable isotope labeled compounds (2H-, 13C- or 15N-labeled)
- Isotope labeling at unusual molecular positions and multilabeling
- Cost-effective production of compounds for use as reference materials, including by-products, impurities, and metabolites, at the highest level of purity (>99%) and in some cases over 20–30 synthesis steps
- Development of new synthetic methods
Endotherm Life Science Molecules has outstanding expertise in the synthesis of complex chiral natural products. These can be plant ingredients, steroids or hormones, amino acids or peptides, coenzyme A esters, polyphenols, (amino) glycosides, vitamin D metabolites, (fluorescent) dyes, or other substances derived from nature.
Depending on the requirements, these can be modified by chemical structural modification
- to improve the pharmacological profile
- for use as biomarkers in metabolism studies
- for the development of fluorescence-based assays
Furthermore, retinal analogs are successfully used to study light-gated ion channels or receptors in the cutting-edge research field of optogenetics.