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.

Analytical Expertise

Cell-based bioassays (CBA)

• 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
  immunofluorescence.

Ligand/Receptor Binding Assays (LBA)/Enzyme Linked Immunosorbant Assays (ELISA)

• Biolayer interferometry and ELISA are employed to measure the kinetics of
  ligand/receptor interactions to characterize the receptor binding properties of
  biotherapeutics.
• 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.

Pharmacokinetic (Pk)/Toxicokinetic (Tk) Assays

• 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.

Immunogenicity assays

• 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.

Enzyme Linked Immunospot (ELISPOT) Analysis

• 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
  clinical trials.
• ex- vivo stimulation of immune cells to measure frequency of cells specific to the
  antigen of interest, and vaccine efficacy.

Biomarker/Multiplex Cytokine Assays

• Measure the expression levels of cytokines and other protein biomarkers to define the
  host response to novel biotherapeutics and to support clinical immunotherapy trials.

Flow cytometry assays

• Characterize the immunophenotypic properties of cell populations. Measure viral
  transduction efficiency.

Cellular Imaging/Microscopy

• Measure and image cellular response(s) to treatments and manipulations.
• Measure and image viral transduction efficiencies.

Enzymatic/Biochemical assays

• Measure the enzymatic activity of expressed gene therapy products.
• Measure the agonistic and antagonistic properties of new chemical entities against their
  biological target.
• Measure the biochemical response (cytokine production, cellular proliferation/death) of
  cells treated with test articles.

GMP-Lot & Market Release Testing

Stability/Lot 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.

Protein analytical characterization

• Biologic-based drugs are tested for bioactivity, purity, concentration, cross reactivity,
  degradation, and receptor binding. Certificates of Testing document all analytical
  procedures.

Drug-Specific Tests

Oncolytic Virus and Gene Therapy Products

• 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
  vesicles).

Biosimilars

• 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
  biosimilars.
• 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.