Element’s comprehensive suite of cell-based bioassay services represent a complete tool kit that goes well beyond routine molecular separation and sample analysis.
Leading biopharmaceutical companies rely on Element’s cell culture facility and bioassay laboratory to fortify their drug discovery and development programs. From determining candidates and making initial investment decisions to lot release and stability testing, cellular assays are critical throughout biologic drug development. Not only are reliable and accurate methods for determining drug potential and efficacy early in development essential, but cell-based bioassay development and biological assay validation must be accomplished quickly, given the highly competitive biologic industry, particularly for cell and gene therapy modalities.
Reliable potency assays are arguably the most important cell-based bioassays, as these assessments are needed to characterize the ability of a drug to drive biologic activity in accordance with the intended therapeutic function, per ICH Q6B for biological drug substances and products. Many biologic drug developers rely on CDMOs to meet bioassay demands, and a reliable and credible contract partner for your cell-based assay can be the difference between struggle and success. Leverage the experience and expertise of our team of skilled cell biologists to design cellular assays that carefully assess biologic activity to produce valuable data for product efficacy analysis, internal decision-making, and regulatory processes.
Cell-based bioassay support for all stages of drug development
Confidently navigate regulatory filings and approval processes with the support of our consultative, well-informed team. Element’s biologics laboratory has extensive experience working with most biologic drug modalities, including peptides, monoclonal antibodies (mAbs), proteins/enzymes, antibody-drug conjugates (ADCs), lentivirus/adeno-associated virus gene therapies, cancer vaccines, cell therapies and beyond. With a dedicated BSL-2 facility and years of cell and tissue culture experience, our knowledgeable team can work with any cell type in both monolayer and suspension formats, including different immortalized cell lines (such as MDCK), primary cells, and tissue samples (such as brain, blood, milk and more).
Our end-to-end solutions support all stages of drug development from discovery, preclinical research and clinical trials, all the way to commercial manufacturing and post-market surveillance. Element’s complete suite of CMC testing services include 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. Our scientists are adept at rapidly executing stage-appropriate, custom cell-based bioassay development and validation, in addition to other more routine cellular assays to assess biologic drugs robustly and accurately, regardless of modality, mechanism of action and target.
Comprehensive bioassay capabilities
- Potency assays: Custom bioassay development and validation per ICH guidance, including biologic drug cellular uptake and 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 and apoptosis testing
- Cytotoxicity studies
- Drug target identification and isolation from tissue samples
- Biologic drug characterization
- Basic research and drug discovery
- Biologics License Application (BLA) submission support
- Routine lot testing
- Potency testing within a stability assessment
- Media qualification and characterization
The Element advantage
If you need advanced characterization of biologic drug molecules, potency assay development, cellular response data, lot release support, or more, Element’s cell culture expertise is at your disposal. Accelerate your program by leveraging our history of success and accumulated knowledge with our “off-the-shelf” bioassay solutions for various applications, also known as “platform methods,” saving precious time by eliminating the need to seek out and develop assays for specific purposes from scratch. With our depth and breadth of experience supporting biologic drug development programs, we understand the challenges unique to large molecule therapies and stand ready to provide tailor-made bioassay services and experienced regulatory consulting.
For more information about Element’s cell culture and cell-based bioassay services for biologic drug discovery and development programs, or to request a quote, contact us today.
Biopharmaceuticals and Biologics Analysis
Element’s significant expertise in all stages of biologics R&D, from in-house protein biochemistry and molecular biology to cellular biology and QC experience, supports the entire product development life cycle.
Establish a strong foundation for commercially successful therapies and advance from concept to candidate. Accelerate pre-clinical drug discovery with a large number of biochemical and cell-based assays.
Troubleshooting and Updating Analytical Methods
Element provides troubleshooting and updating analytical methods services to help you achieve more consistent product quality, more efficient manufacturing, reduce cost and save money.
Extractables and Leachables Studies
Our extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.