Therapeutic Proteins
Therapeutic proteins, including monoclonal antibodies, enzymes, and hormones, are utilized as medications to treat various diseases by targeting specific biological pathways and delivering precise therapeutic effects. At Swiss BioQuant AG, we develop and validate sensitive quantitation assays for these proteins using advanced HPLC-MS/MS and HPLC-HRMS technologies. By employing affinity enrichment and microflow HPLC, we achieve exceptionally low limits of quantification.
Monoclonal Antibodies/Nanobodies
Monoclonal antibodies (mAbs) are highly specific drugs that target single antigens, while bispecific antibodies (bsAbs) can bind to two different antigens simultaneously, and nanobodies are smaller antibody fragments that offer unique advantages in targeting and treating diseases. Swiss BioQuant AG has extensive experience in quantifying different antibody modalities by HPLC-HRMS or MS/MS in combination with immunocapturing using magnetic beads and different protein chemistry and digestion strategies.
Due to the importance of monoclonal antibodies in biomedical research, standardized assays for human monoclonal antibodies in animal plasma using automated liquid handling and universal signature peptides are available. In addition, we have successfully quantified human monoclonal antibodies in clinical studies by HPLC-MS/MS (published in: https://link.springer.com/article/10.1007/s00216-024-05375-w).
Modified RNA and DNA drugs
RNA and DNA drugs are at the forefront of modern medicine, offering innovative solutions for treating a variety of diseases at the genetic level. These therapies are particularly significant in the fields of cell and gene therapy.
RNA therapies include small interfering RNA (siRNA), microRNA (miRNA), antisense oligonucleotides, and messenger RNA (mRNA). These therapies can suppress gene expression, alter splicing, introduce new proteins, and even edit the genome. For example, mRNA therapy delivers corrected mRNA into cells, providing the blueprint for healthy proteins. However, RNA is inherently unstable and rapidly cleared from the blood, making delivery a significant challenge.
DNA therapies, often referred to as gene therapies, aim to replace problematic gene sequences with healthy ones, effectively stopping a disease at its source. This can involve inserting corrected genes into a patient's cells or removing harmful genes. Gene therapy medicinal products (GTMPs) involve vectors or delivery systems containing a genetic construct engineered to express a specific therapeutic sequence or protein.
HPLC-MS assays can support Oligonucleotide quantitation in tissue and plasma samples as well as quantitation of involved proteins.
HPLC-MS is the method of choice for oligonucleotide analysis, because it can directly measure individual strands and is sensitive to smallest changes in the molecular structure of nucleic acids. Swiss BioQuant AG offers state-of-the-art quantification of oligonucleotides with different backbone chemistries using SPE workup and ion-pairing or HILIC HPLC-MS/MS. In addition, we provide HPLC-HRMS approaches to study the in-vivo metabolism of oligonucleotides.
Antibody Drug Conjugates (ADC)
ADCs have emerged as an exiting new modality for oncology indications to delivery cytotoxic agents to their intended site of action in a highly targeted manner. Derived from monoclonal antibodies, ADCs feature their parent molecules’ excellent selectivity and release their cytotoxic payload after cleavage of a synthetic linker structure within their target cells. As such, ADC pose unique analytical challenges, including the drug-antibody-ratio (DAR), unintended loss of payload and metabolism of the linker-payload structure. Swiss BioQuant AG offers DAR analysis based on intact protein HPLC-MS, linker-payload metabolite identification by HPLC-MS/MS as well as quantification of total ADC and intact ADC by HPLC-MS/MS. Furthermore, we offer HPLC-MS/MS assays of commonly used ADC toxins with pg/mL sensitivity, including MMAE, Exatecan and PNU-derivatives.
Glycan analysis
Swiss BioQuant develops and validates analytical methods for targeted quantification of carbohydrates in various types of biological matrices.