Skyland Analytics announced recently that Histogenics has deployed Skyland’s Centralized Limit Management™ (CLM™) software to streamline management of critical data in its process development, product scale-up and commercial manufacturing operations.
“After evaluating several process data management tools, we not only believe that CLM meets our current data management needs, but that Skyland’s product roadmap will also meet our future needs. We are now moving our process data to Skyland’s Part 11-compliant CLM workspace which allows us to organize our data by product and process formulations, unit operations, market of sale and site of production without any customization or configuration,” said Histogenics’ Executive Vice President and COO, Steve Kennedy.
“As industry leaders and innovators in personalized medicine, the Histogenics team knew what features and functions were necessary to manage their data throughout the product lifecycle. They helped us refine our first release to not only meet their specific needs but those of peers across global and emerging pharmaceutical companies,” said Robert Di Scipio, CEO of Skyland Analytics.
Histogenics is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use. Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018. NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.
About Skyland Analytics
Skyland Analytics, Inc. develops data analytics and data management software for pharmaceutical, chemical, and food and beverage companies managing manufacturing processes and product quality across internal and external networks. CLM equips manufacturers with a simple, validatable, cloud-based repository of specification limits and target control values. This market-leading module enables access across the manufacturing network to essential data that supports monitoring, ad hoc investigations, process analysis, Continued Process Verification (CPV) management and other critical initiatives.
SOURCE: Skyland Analytics