Expert Large Molecule Bioanalysis Testing Services for Accurate Results
Large molecule or biologic drugs are a diverse class of compounds varying in size, complexity, and mode of action with broad therapeutic applications. Due to this wide range of large molecule therapeutic types, bioanalytical support for these drugs requires a CRO provider with a comprehensive depth of expertise across therapeutic modalities and a large selection of bioanalytical tools or resources.
Our experience in the large molecule space
BioAgilytix has a long history of supporting assays for large molecule therapeutics. In fact, our experienced scientific team has provided bioanalytical testing for more than a third of the biologics that were approved by the US FDA between 2018 and 2020. Our expertise spans a wide range of large molecule modalities including:
- Biosimilars
- ADC
- Monoclonal antibodies
- Bi-specific/tri-specific proteins
- Enzyme replacements
- Recombinant proteins
- Off-the-shelf assay menu
BioAnalytical services for each drug development phase
Our established regulatory infrastructure allows us to provide compliant assays across all stages of drug development including non-regulated, GLP, GCLP, and GMP. We have multiple global locations and maintain SOPs that are consistent for regulatory authorities around the world. Our flexibility and established procedures ensure that we can work with our clients to provide bioanalytical solutions through the full life cycle of their therapeutic programs. We offer a full suite of bioanalytical services for every regulatory stage including:
Pharmacokinetics (PK)
Understanding the PK profile of a given therapeutic is an essential element of assessing its efficacy and safety. PK evaluations help to define the proper dosage, route, and schedule of administration during preclinical and clinical studies.
Pharmacodynamics (PD)
PD assessments in early drug development studies can provide vital information on biological effects to help the design of later clinical studies to improve treatment. PD biomarkers are used in preclinical and clinical studies for establishing dosing regimens and therapeutic efficacy.
Immunogenicity
Immunogenicity risk assessment is critical to the development of most therapeutic modalities. It can affect both safety and efficacy, ranging from no evidence of clinical effect to severe, life-threatening responses. Assessment of undesirable immunogenicity of therapeutics is a key element in drug development.
Biomarkers
Biomarker analysis enables you to assess a therapeutic’s efficacy, safety, and mechanism of action to make go/no go decisions during the drug development process. Biomarker assays can also validate targets and identify potential toxicity.
CMC Bioanalytical
CMC bioanalytical testing is required for all drug development programs. These assays are used to monitor the drug manufacturing processes and ensure the safety, efficacy, and quality of pharmaceutical products. CMC bioanalytical strategies are inherently complex and must be individualized for each therapeutic program.
Diagnostic Testing
When you need a dependable diagnostic testing laboratory partner who consistently delivers reliable testing results on time, choose BioAgilytix Diagnostics. If tailored testing and responsive service matter to you, BioAgilytix Diagnostics should be your provider of choice.
Biosimilars
Rely on the combined power of BioAgilytix’s veteran scientists, advanced platforms, and validated techniques to quickly progress the development of your promising biosimilars. Our scientists have experience supporting biosimilar studies with a number of assays for generics, including ligand binding assays, characterization, and stability testing on multiple platforms.
ADC Testing
Antibody drug conjugates (ADCs) continue to show significant therapeutic promise, and BioAgilytix is here to help support their development for life-changing outcomes. We have been supporting customers at the leading edge with expert antibody drug conjugate testing services, and will apply that first-hand expertise to your distinct project requirements.
End-to-end support
BioAgilytix is able to build sustainable, long-term partnerships with our clients due to our ability to provide bioanalytical solutions at any stage of the drug development process, from start to finish. We focus on maintaining a wide selection of instrumentation and a robust regulatory infrastructure in order to provide competitive service offerings for all the various large molecule therapeutic modalities. BioAgilytix’s commitment to delivering high quality data across each of our programs combined with our depth of expertise in large molecule bioanalysis means we can ensure that we deliver critical data to support successful large molecule programs.
Equipment and software for dose formulation analysis
BioAgilytix has invested in new UPLC systems for dose formulation analysis and built out a separate lab space to isolate these high concentration samples from the sub nanogram level bioanalytical samples. The new UPLC systems have UV/VIS, diode array, CAD (Charged Aerosol Detection), and fluorescence detection capabilities.
Case Study
Simultaneous determination of drug concentrations
Learn how the development of a novel extraction and derivatization scheme allowed us to simultaneously determine free and covalently bound drug concentrations using a single assay.