Biologics bring unique development challenges. Let us help you overcome them.
Unlike other types of therapeutics, biologics are complex formulations that can be difficult to characterize and identify. This makes it more difficult to generate the required scientific evidence to support drug submissions.
Custom Biologics is universally recognized for its expertise in assay design, attention to detail and scientific excellence in biologic, vaccine, and gene therapy drug development. Our assays are utilized in pre-clinical research and development programs or as validated GMP- compliant assays suitable for stability analysis, clinical analysis, and clinical/market lot release testing. By using state of the art bioanalytical laboratory equipment and sophisticated statistical software , the data we generate are used in submissions to regulatory agencies worldwide.
- Cell-based bioassays are designed and employed to assess the mechanism of action and potency of biologics, vaccines, oncolytic viruses, and gene therapy drug candidates. EC50 and relative potency values provide a measure of the functional activity of the test article.
- Different assay platforms, along with rigorous statistical analysis, are employed to
measure the different functional activities of biotherapeutic and gene therapy drug
candidates. These include: enzymatic/reporter-based assays, complement dependent
cytotoxicity (CDC), antibody dependent cellular cytotoxicity (ADCC), potency,
proliferation, migration, inhibition, apoptosis, cytokine release and
- Biolayer interferometry and ELISA are employed to measure the kinetics of
ligand/receptor interactions to characterize the receptor binding properties of
- These assays are routinely employed to deduce the pharmacokinetic and toxicokinetic
profiles of biotherapeutics and to quantify the levels of vaccine and gene therapy
vectors in biological matrices.
- Pk and Tk assays are employed to assess the pharmacokinetic and toxicity profiles (or
properties) of biotherapeutic drug products.
- Different biological matrices (human, non-human primate (NHP), mouse, rat, rabbit)
- Sensitive assay platforms and accurate measurements support pre-clinical testing
studies and clinical trials.
- The immunogenicity of a biotherapeutic must be evaluated for its capacity to induce
anti-drug antibodies (ADA) and neutralization antibodies (NAB) as these can impact the
therapeutic efficacy and safety and the drug candidate.
- ELISPOT assays are sensitive immunoassays to measure specific-cytokine secreting T-
cells at the single-cell level.
- Employed to monitor T and B cell immune responses during preclinical testing and
- ex- vivo stimulation of immune cells to measure frequency of cells specific to the
antigen of interest, and vaccine efficacy.
- Measure the expression levels of cytokines and other protein biomarkers to define the
host response to novel biotherapeutics and to support clinical immunotherapy trials.
- Characterize the immunophenotypic properties of cell populations. Measure viral
- Measure and image cellular response(s) to treatments and manipulations.
- Measure and image viral transduction efficiencies.
- Measure the enzymatic activity of expressed gene therapy products.
- Measure the agonistic and antagonistic properties of new chemical entities against their
- Measure the biochemical response (cytokine production, cellular proliferation/death) of
cells treated with test articles.
GMP-Lot & Market Release Testing
- Validated assays for GMP-compliant stability and clinical trial; lot release testing of
biologics can be performed according to fixed and controlled schedules that adhere to
stipulated testing requirements and turn-around times.
- Biologic-based drugs are tested for bioactivity, purity, concentration, cross reactivity,
degradation, and receptor binding. Certificates of Testing document all analytical
- Infectivity, viral placque forming unit titering, and quantification are routinely employed
to characterize the critical quality attributes of vaccines, oncolytic viruses, gene therapy
vectors (lipid nanoparticles, Adeno Associated virus, Lentivirus, exosomes, cellular
- Establish qualified and validated ligand binding assays and cell-based assay to support
the functional CMC characterization, comparability, clinical PK, lot release and
immunogenicity assessments of biotherapeutic monoclonal antibodies and their
- A full list of biosimilars and their associated assays can be found here
- A comprehensive set of bioanalytical and mass spectrometry-based assays is conducted
by our partner laboratory, BioPharmaSpec, to characterize the structure of
biotherapeutic monoclonal antibodies.