Protein concentration is an obligatory critical quality attribute that is necessary to determine total protein content in biopharmaceutical formulations. Concentration determination is also required before many other assays can be performed. A UV-based spectrophotometric assay utilizing the protein’s extinction coefficient is the most typical method used.

Using a conventional UV method with cuvettes, or specialized approach using variable pathlength slope spectroscopy, although very accurate and precise, would take one day to measure 15 samples in triplicate. Larger or multiple submissions would require more analysts for a single day turnaround time.

With large study submissions across various projects, protein concentration analysis becomes a key deliverable before all other methods can be performed; thus, efficient rapid concentration analysis with a minimal volume requirement is essential. 

The Lunatic (Unchained Labs, Pleasanton, CA) offers rapid, plate-based concentration measurement with minimal prep and sample volume requirements. The Lunatic utilizes only 2 microliters per sample and can analyze 96 wells in less than 12 minutes.

We have qualified the Lunatic with respect to accuracy, precision, linearity and specificity. Upon qualification, a wide range was determined, 0.03 mg/mL to 176 mg/mL. The Lunatic has shown to be fit-for-purpose and deemed a superior method with regard to range, sample throughput, and cost savings.

By deploying the Lunatic for protein concentration measurements, we achieved high-throughput and wide-range protein concentration analysis capability, while delivering a 20-fold improvement in time and budget savings.

In this webinar you’ll learn:

• How to counteract the increasing risk of missing deadlines due to slow one-at-a-time quantification on large numbers of samples
• How to save on increasing costs due to high sample requirements
• How GSK has qualified Lunatic for accuracy, precision, linearity and specificity 

• Scientists
• Directors of Assay/Analytical Development
• VPs of Protein/Biologics Products
• Directors of Quality Control