Cellular assays play a critical role throughout biologic drug development—from determining candidates and making initial investment decisions to lot release and stability testing. Among cell-based bioassays, reliable potency assays are arguably the most important assessment. These are used to characterize a drug’s ability to drive biologic activity in line with its intended therapeutic function. Demonstration of biologic activity is required per ICH Q6B for biological drug substances and products.
For internal decision-making and regulatory processes, drug developers need reliable and accurate methods for determining drug potential and efficacy early in development. Cell-based bioassay development and validation also needs to be performed quickly, given the competitiveness of the biologics industry, especially for modalities like protein, gene, and cell therapies.
To accommodate bioassay demands, drug developers often turn to CROs – though capabilities vary greatly in this area. Finding a reliable and credible contract partner for your cell-based assay needs can be the difference between struggle and success.
Why Drug Developers Look to Avomeen for Bioassay Services.
Avomeen’s cell-based bioassay services represent a complete tool kit that goes well beyond routine molecular separation and sample analysis. Powered by expert cell biologists, our cell culture facility and bioassay laboratory can fortify your drug discovery and development program. Our expert team can design in vitro cellular assays that carefully assess biologic activity, generating valuable data for internal decision-making and product efficacy analysis.
Avomeen’s biologics laboratory has far reaching experience working with most biologic drug modalities, including proteins/enzymes, monoclonal antibodies, antibody-drug conjugates (ADCs), peptides, adeno-associated virus and lentivirus-based gene therapies, cancer vaccines, cell therapies, and beyond.
Whether you need advanced characterization of biologic drug molecules, potency assay development, cellular response data, lot release support, or anything else, Avomeen’s cell culture expertise is at your disposal.
Avomeen’s Cell-Based Bioassay Capabilities
Avomeen can skillfully incorporate cellular assays into your drug development program, adapting to your project needs. With years of cell and tissue culture experience and a dedicated BSL 2 facility, our team can work with any cell type in both monolayer and suspension formats, including different immortalized cell lines (such as MDCK, CHO, HEK293, and more), primary cells, and tissue samples (such as brain, blood, milk, and more).
Our scientists support clients at all stages of their drug development program from discovery, preclinical research, and clinical trials, all the way to commercial manufacturing and post-market surveillance. In particular, we place special importance on our ability to help our clients confidently navigate regulatory filings and approval processes. To support our client’s CMC activities, we offer a complete suite of CMC testing services, including in vitro potency testing, in vitro cellular uptake, MTS assays, permeability studies, and large molecule characterization, as well as IND/BLA submission support and regulatory consulting.
We know firsthand that CMC activities are not the same for every biologic drug candidate. That’s why our scientists are adept at rapidly executing custom cell-based bioassay development and validation, in addition to other more routine cellular assays. These custom assays accurately and robustly assess your biologic drug, regardless of modality, mechanism of action, and drug target. Importantly, our method development and biological assay validation services are always built to be stage appropriate.
Our Bioassay Capabilities Include:
- Potency assays: custom bioassay development and validation per ICH guidance, including:
- Biologic drug cellular uptake
- Cellular response to a biologic drug
- Bioassay method optimization
- Drug permeability assays
- Cell proliferation and viability determination (MTT/MTS assays)
- Cytokine screens
- Reporter gene assays by fluorescence
- Gene expression analysis
- Cell signaling assays
- Ligand binding assays
- Cell death & apoptosis testing
- In vitro cytotoxicity studies
- Drug target identification & isolation from tissue samples
- Biologic drug characterization
- Basic research and drug discovery
- BLA submission support
- Routine lot testing
- Potency testing within a stability assessment
- Cell banking
- Media qualification and characterization
Fitting Your Exact Cellular Assay Needs with Avomeen
Alongside our cell culture and biologic drug development skillsets, Avomeen has repeatedly shown the ability to collaborate effectively with teams across a diverse spectrum of biopharma organizations. Having worked with everyone from small virtual drug discovery groups to large biopharma companies, we understand the challenges you’re facing and can help. Whether you lack in-house biological expertise and specialized equipment, or simply don’t have the capacity to execute your own bioassay plan with your current resources, Avomeen can support your biologic program with tailor-made bioassay services and experienced regulatory consulting.