Case Study 1: Reagent Antibodies for Evaluation of Drug Levels and Activity in Patient Sera
Antibodies for Detection and Neutralization of Biotherapeutics
There is a need for antibodies in pre-clinical and clinical studies for the detection of potential biotherapeutic antibodies (Th-Mab) and also for the blocking of the therapeutic to its specific ligand target (anti-idiotypic/neutralizing (anti-ID Nab)).
As there is a potential for adverse effects on the animal’s immune system from either the active drug-antigen and/or resulting circulating antibody during the immunization phase, specifically designed immunization protocols are used to abrogate potential adverse effects.
Case Study 2: Reagent Antibodies for Evaluation of Drug Levels in Patient Sera
Antibodies Specific for Parent Small Molecule Drug Over Potential Metabolites
Mice were immunosuppressed with the metabolite (oxide form of the drug) and then challenged with the parent drug. Following fusion, clones producing specific antibody to the parent drug were selected over clones producing antibodies to the metabolite. An ELISA was then developed using the parent drug specific antibody to detect drug in patient sera samples.
Successful Green Mountain Antibodies Targets
- Small molecules (including drug candidates)
- Other small synthetic chemical entities (cGMP, cAMP, therapeutics, others)
- Biotherapeutics (Biosimilars)
- Proteins
- Peptides
- Ion channels/transporters
- GPCR’s
- Membrane targets
- Pre-clinical/Clinical
- Antibodies for PK/PD
- Antibodies for drug level measurements
- Antibodies for neutralization assays
- Antibodies for post marketing validation
- VLP’s, proteoliposomes, nanoparticles
- DNA/RNA
- Glycans/carbohydrates
- Drug delivery systems (CAR T, ADC, others)
Green Mountain Antibodies – Notable Successes
- Reagent antibodies for Pre-clinical and Clinical studies (ADA, PK, Tox, Neutralizing, functional evaluation)
- Small molecule therapeutic development studies (Zeljanz, Voriconazole, Azithromycin, Cortisol, cyclophosphamide)
- Functional antibodies (agonist, antagonist)
- Reagent antibodies for various assay platforms: immunohistochemistry, flow cytometry, Western analysis, immunoprecipitation, ELISA, MSD, Gyros, etc.
- Reagent antibodies for pharmacodynamics studies
- Reagent antibodies for evaluation of drug levels in sera (antibodies specific for parent drug over potential metabolites)
- Reagent antibodies that distinguish specific arms of bi-specific antibodies
- Antibodies for biotherapeutic candidate development
- Antibodies for diagnostic kit development
- Reagent antibodies for quality control evaluation of marketed drug products
- Internal product line development