CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, is pleased to announce the appointment of Brandon Zurawlow to the position of Chief Scientific Officer. In this role, Brandon will assume immediate responsibility for all aspects of client services and laboratory operations. He will be instrumental in aligning testing capabilities across platforms and standards including as USP, EP, ASTM, and custom testing procedures to deliver comprehensive solutions that exceed client expectations. In addition, he will specifically manage USP〈1207〉container closure integrity (CCI) functions from consultative strategy development, method development, validation, and implementation for all CCI Testing programs. Concurrently, through collaboration with industry partners, Brandon will oversee allocation of resources for research in this specialized field, ensuring CS Analytical remains at the forefront of innovative and customized solutions for package development and qualification.

“Brandon is one of the very few people in this world that has dedicated his life’s work to the field of container testing and qualification. With experience that spans hands-on and leadership roles in the contract laboratory setting, independent consulting on key regulatory issues, hosting training on USP 〈1207〉, and publishing relevant scientific documents on these topics, we are excited to have him on our team. He brings a level, depth, and breadth of knowledge to our company that is always delivered in a professional and passionate manner.” commented Brian Mulhall, CS Analytical CEO.

“Joining the experienced team at CS Analytical, a third-party solutions provider uniquely dedicated to container testing, is something I’m thoroughly excited about. Returning to the contract laboratory setting is the logical next step for me and something that the pharma, biotech and medical device industries have a demonstrable need for. CS Analytical will serve an unmet need in the marketplace, which my existing and future clients will benefit from,” added Brandon.

The advent of biologics and other complex formulations, along with unique distribution, storage, and dose delivery requirements, has resulted in container and package systems that are both more complex and regulated today. Whether a pre-filled syringe storing a biological drug product at -80°C or a multi-function, self-reconstituting autoinjection device system constructed of numerous components, the end requirement is the same: demonstrate suitability for intended use. However, tests required to demonstrate suitability can vary widely, including, for example, USP〈381〉, USP〈660〉, USP〈661〉and USP〈1207〉.

As regulations and best practices surrounding package testing continue to increase in complexity, volume, and demand, a custom-tailored test approach that closely considers internal and external requirements is key to success. Working with a custom-built contract laboratory, in tandem with experienced and passionate thought leaders dedicated to this specific set of issues, can be the difference between a deficiency-laden regulatory response and the smooth launch of a billion-dollar drug product.