New Service Offering Provides Same Day Results
Pharmacokinetic (PK) assays measure drug concentration in animals and humans, typically in serum or plasma samples. PK assays are normally associated with drug development and drug safety (toxicology) studies. Because PK assays are one of the most common and essential tests performed in drug development, sponsors often desire expedited delivery to meet development needs and project deadlines. To strengthen the value that we provide to our sponsors throughout the drug development process, we are now offering our sponsors an expedited approach to PK assays.
Some highlights of our expedited PK capabilities include:
- Human IgG drugs dosed in rat
- For non-regulated, non-GLP discovery and research applications
- Serum or plasma matrix (between and 2-25 uL per well required)
- 96-well Ligand Binding Assay (Immunoassay) format
- Approximate quantitation range of 2 ng/mL to 2,000 ng/mL
- Up to 250 samples run in 1 day (non-expedited service, samples in duplicate, 3 QC levels)
- Same day sample analysis:
- Data provided in a non-QA’d excel spreadsheet
- Up to 60 samples
- Manifest in excel format required
- Barcoded sample vials or 96 well plates required
- Method development completed in 2 days
- Establish range of standard curve, LLOQ, ULOQ, placement of QC’s, MRD
- Method qualification completed in 1 day
- 3 accuracy and precision runs, dilutional linearity
Our troubleshooting support can include establishing assays that are not derived in rat origin, biologic drug that is not human IgG, or other analytes specific challenges. No matter the issue, we are willing to work with you to meet your specific needs.
The table below provides an example of our expedited Discovery PK service measuring Humira® from rat serum.
Table 1. Representative discovery PK data. Humira® was dosed in rats. Conjugated anti-human IgG antibodies were diluted in assay buffer and pipetted into desired wells (master mix). Undiluted (neat) rat serum samples were added to the master mix at 25 uL per sample per well. The plate was placed on a shaker at 300 RPM for 30 minutes and was evaluated by a plate reader.