Founded in 2012, NovaBioAssays LLC is a Greater Boston-based contract research organization (CRO) specialized in providing innovative analytical and bioanalytical solutions to facilitate drug discovery and development. NovaBioAssays LLC occupies the two-story building with 12,000 SF space, and 10,000 SF for future expansion. We offer a full suite of analytical and bioanalytical services for quantitative and qualitative analysis of small molecules, oligonucleotides, peptides, and proteins.
Historically, immunoassays and other ligand-binding assays (LBA) have been the golden standard for quantifying proteins in biological fluids to support preclinical and clinical studies due to their high sensitivity and throughput. However, the resource and time consuming process for reagent production and selection routinely results in lengthy assay development period (>6 months). In addition, the selectivity of LBA is prone to be compromised by presence of endogenous interfering molecules in different matrices, especially in tissue samples. With recent development on mass spectrometry instrumentation and methodology, approaches for protein quantitation based on liquid chromatography mass spectrometry (LC-MS) have matured lately. LC-MS/MS assays have been increasingly used as the alternative for the absolute quantification of the endogenous biomarker proteins, and the therapeutic recombinant proteins or mAbs. LC-MS/MS assays are especially useful for situations when quantifying therapeutic proteins in human serum in the presence of pre-existing anti-drug antibodies; when required to quantify the therapeutic protein and its metabolites simultaneously; or when the reagents for LBA are not available. At NovaBioAssays, we provide a variety of LC-MS/MS-based platforms as well as traditional LBA methods to meet our clients’ bioanalytical needs.
Hydrogen Deuterium eXchange Mass Spectrometry (HDX-MS) is a powerful technique to study protein dynamics, protein folding, protein-protein interactions, protein small molecule interactions, as well as protein-RNA interactions. Novabioassays has built its reputation in providing HDX MS service for epitope mapping, biosimilarity comparison, studying small molecule-protein interactions, peptide-protein interactions, protein-protein interactions, and RNA-protein interactions for many small and large pharmaceutical companies globally in the past five years.
At Novabioassays, we have achieved almost 100% successful rate in performing epitope mapping for more than 200 antibodies targeting more than 40 different antigens (from ~10 kDa to ~200 kDa) to support our clients’ patent applications and/or IND filings.
NovaBioAssays uses advanced liquid chromatographic assays and ultrasensitive ELISA to quantify oligonucleotide therapeutics in biological matrices. While some ELISA assays are more sensitive, the chromatographic based methods are more specific and able to quantify multiple analytes in one assay. The chromatographic based assays can also conduct metabolite identification and/or quantification simultaneously.
NovaBioAssays provides the LC-MS or LC-MS/MS based analysis for Antibody-Drug Conjugates (ADCs) and other conjugates, such as bispecific antibodies, Fc fusion proteins, antibody fragments (Fab, Fc, and Nanobodies), etc.
Services for ADCs and other conjugated products include:
NovaBioAssays emphasizes the Reference Standard and Biosimilarity Characterization via LC-MS and LC-MS/MS technology, including:
Biochemistry & Molecular Biology Services
Protein Purification and Quantification Services
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