Liquid Chromatography-Mass Spectrometry (LC/MS) is a technique that is used for separation, identification, and quantification of both unknown and known compounds as well as to elucidate the structure and chemical properties of different molecules. LC/MS is a common technique applied to the bioanalytical support and quantitation of large and small molecules during drug development. At BioAgilytix, our global scientific experts run the most advanced LC/MS platforms to deliver accurate, reliable LC/MS data for a variety of therapeutic programs. In fact, BioAgilytix has developed more than 2,400 proprietary and non-proprietary methods, including many validated and ready-to-validate non-proprietary assays.
BioAgilytix’s LC/MS expertise
Our bioanalytical scientists are experts at developing assays in liquid, non-liquid (soft and hard tissues), and many rare biomatrices, including but not limited to spinal cord homogenate, vitreous humor, aqueous humor, bone marrow, cerebrospinal fluid, and endothelial lining fluid. We also frequently implement a variety of sample cleanup methods, including protein precipitation, solid-phase extraction (SPE), supported-liquid extraction (SLE), liquid-liquid extraction (LLE), or a combination of these for specific small molecule applications.
For large molecule and protein biotherapeutic applications, sample extraction is performed by employing generic or anti-idiotypic capture reagents for immunoaffinity-based enrichment, followed by proteolytic digestion to develop hybrid immunoaffinity LC/MS assays. Depending on the assay requirements, we work with the sponsor to evaluate the need for enrichment and available options before initiating the method development activity.
Leverage our LC/MS capabilities for all phases of drug development
At BioAgilytix, we support LC/MS assay creation starting with feasibility and development and continuing through qualification and/or GxP-compliant validation. Our scientific teams work with you to understand your drug discovery and development program goals. This collaboration helps establish the appropriate level of compliance based on the stage of your program, from early discovery through post-market approval.
Our scientific teams have utilized LC/MS techniques to quantitate a broad range of therapeutic modalities and biomarkers, including but not limited to:
- Proteins (biomarkers/drugs)
- Antibody-drug conjugates (ADCs)
- Antibody or payload
- Drug to Antibody Ratio (DAR)
- Monoclonal antibodies (mAbs)
- Fusion proteins
- Lipid nanoparticles (LNPs)
Choosing LC/MS for your bioanalytical needs
LC/MS solutions to address key bioanalytical challenges is an underserved area in the industry. At BioAgilytix, we have invested significant resources into maintaining the top-of-the-line equipment and scientific expertise necessary to provide high quality LC/MS services that meet the demand from our clients.
The best and most common approach for analysis of small oligonucleotide drugs such as siRNA, ASO, and aptamers is LC/MS. This technique provides the most appropriate level of sensitivity and specificity due to the difficulty in analyzing these molecules via traditional molecular techniques like qPCR/ddPCR. LC/MS is the gold standard for assays characterizing or analyzing lipid nanoparticles (LNPs) and for supporting the payload analysis or drug to antibody ratios (DARs) for antibody-drug conjugates. LC/MS is often the optimal platform for large molecule quantitation and bioanalytical testing, as well. Traditional ligand binding assay (LBA) techniques such as ELISAs can be inadequate for the nuanced data required for monitoring many biologic therapies. Examples of situations where LC/MS techniques can prove dramatically better than LBAs include quantitation of a drug with high homology to an endogenous component or quantitation of a truncated version of a protein.
Whether your drug is large or small, our experienced team is ready to provide you with the critical LC/MS support you need to make your program successful.
Collaborate with an experienced LC/MS team
To serve all your small and large molecule LC/MS needs, we offer a dedicated, skilled, and committed team with decades of relevant experience to support drug quantitation and biomarker assay development from early discovery to post-commercialization. Talk to one of our LC/MS experts today to learn how we can use our expertise with LC/MS techniques for the generation of high quality, critical data in support of your drug development program.
Speak to a scientist today
Learn more about how BioAgilytix can help you reach your discovery drug development goals