As an example of an application use for Waters' technology, Craze foresees that biosimilars—identical copies of an original product— represent a growing demand for provision of sufficient analytical and biological evidence between innovator and biosimilar candidates. For biotech organizations challenged to deploy high-resolution analytics across the innovative biotherapeutic or biosimilar development process, Waters designed a progressive informatics platform called UNIFI®, which processes data from advanced and routine analyses to characterize sample compositions, using LC-MS technology. The platform enables a biotech laboratory to comprehensively and routinely acquire, process, and report LC and MS characterization data throughout the biotherapeutic development lifecycle.
“We have integrated our platform with solution kits and workflows, thus providing massive data integrity advantages to customers,” illustrates Craze. “UNIFI’s data mining and comparison capabilities enhance the ability to understand results, and to aggregate and manage data,” he adds. Furthermore, UNIFI provides organizations with the flexibility to deploy UNIFI-based systems within both regulated and non-regulated laboratory environments, while employing high resolution UPLC separations and high performance MS across the entire product lifecycle from discovery to development, and quality control.
UNIFI’s data mining and comparison capabilities enhance the ability to understand results with an unparalleled capability to aggregate and manage data
Since inception, Waters has become attuned to a culture of understanding and addressing client needs. For instance, one of their clients MacroGenics, Inc., a clinical-stage biopharmaceutical company, required a solution to reduce their risk of downstream failure, support their workflow, and provide highly accurate molecular weight information on intact molecules. Deploying the UNIFI platform in their environment helped the client to take their top-down analysis time from 1-3 weeks to 2-3 days. Waters scientists considered every aspect of peptide analysis—from chemistries, instrumentation, software, and methodology to usability, documentation, application support, and remote services—to create fit-for-purpose system solutions for peptide analysis and peptide mapping. As a result, MacroGenics reduced its peptide mapping cycle time from around 3-6 weeks to a single week.
Waters maintains a network of laboratories located around the globe so that customers can interact with the firm’s scientists and prototype implementations of their products. Moreover, Craze understands the need of planning Drug Metabolism and Pharmacokinetics (DMPK) (www.dmpk.waters.com) investments strategically to meet the future demands of laboratories that are expanding as organizations work to reinvigorate their drug product pipelines.
Waters is unique as a technology vendor in the pharmaceutical space, in that it has a very strong applied science base. A significant proportion of its global marketing team has previously worked directly within the pharmaceutical sector - some have even been personally responsible for running major DMPK functions. As such, Waters has a deep understanding of both the science involved in DMPK, the logistics associated with running an efficient operation, and a high degree of awareness towards innovation in the field, and industry dynamics.