ESA Corona^® CAD™ Enables Critical Methods Development, Verification, and Global Transfer of Methods in Just Weeks for a Major Pharmaceutical Company

ESA Biosciences, a Magellan Biosciences company, announced that a top-ten pharmaceutical company has now standardized on the Corona CAD (Charged Aerosol Detector) for a number of critical pharmaceutical development and manufacturing QC applications.

The pharmaceutical company was in the final development and scale-up stage of its most-promising new drug and turned to the Corona universal detector after more-traditional technologies, such as ultraviolet detectors, proved inadequate to deliver the sensitivity, selectivity, robustness, and ease-of-use necessary to meet the exacting standards for product launch.

According to the customer’s associate director of analytical research and development, the formulation for the product is extremely complicated, with more than 80 individual components. Before trying Corona CAD, his team had already exhausted nine out of the 12 months allotted for final development and manufacturing scale-up of the therapeutic, attempting to develop a low-wavelength UV-detection-based method, without success.

“This therapeutic product is arguably the company’s most-important launch in nearly a decade, and we feared it was going to be delayed because the available analytical tools for final development and QC were not up to the task. When a scientist in our division saw a poster presentation at a tradeshow describing the Corona CAD and had a hunch it would work for our project, we immediately asked for and received a unit for evaluation in our New Jersey facility. We found to our relief and delight that it exceeded all expectations. We were able to develop and validate three critical methods (for impurity analysis, excipient and formulation characterization, and final product QC) in only a few weeks. We then successfully transferred the methods to our manufacturing facility in Ireland, and they are now in active use on the factory floor after only five days of training.”

As is typical in the pharmaceutical industry, methods development at this company takes place in one central facility. Once a method is validated, it is then transferred to other facilities for implementation around the world. Previous methods development and transfer has taken months, and often, extensive, long-term follow-up support is required from the development team. To date, the company has more than 15 Coronas in operation around the world in a variety of critical applications.

Said ESA’s Vice President of Sales and Marketing, John Christensen, “Corona is a robust, reliable, plug-and-play device, which requires no calibration or optimization – so even those with minimal training can run it. These are critical parameters for an instrument designed to have equal utility in an R&D lab and in the harsh environment of the factory floor. Operators need only inject the sample, turn on the nitrogen gas, and press one button to get results – we’ve put all the sophistication and complexity inside the box.”

Mr. Christensen continued, “Corona has been widely adopted by all the leading pharmaceutical companies worldwide because it solves analytical challenges that no other technology can. The ideal complement to UV detection, Corona delivers orders-of-magnitude advantages in sensitivity, dynamic range, consistency, reproducibility, and ease of use, providing universal high-performance liquid chromatography (HPLC) detection of virtually any non-volatile or semi-volatile compound, including proteins, lipids, carbohydrates, and small molecules. Since its introduction in late 2004, the Corona has proven essential for anyone who is focused on accelerating product development or ensuring the timely roll-out of products that meet quality specifications.”