BACKGROUND
Histogenics is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ technology platform has the potential to be used for a broad range of restorative cell therapy indications. The company’s 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 completed enrollment of its NeoCart Phase 3 clinical trial and reported top-line 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.
BUSINESS NEEDS
- Outgrew Excel database tools
- Process knowledge for commercial manufacturing
- FDA validatable tool
- Develop process control strategy
SOLUTIONS CONSIDERED
- Enterprise systems; too pricey, required heavy IT infrastructure and complex implementations
REQUIREMENTS MET
- Uses the process control strategy as the basis for manufacturing process data management
- Met user requirements
- Easily accommodates different types of manufacturing processes
- Interface is clean and straightforward for entering/viewing information
- Backend is logically organized
- Enables traceable data verification and maintains overall data integrity
- Affordable
“We are excited by the release of Skyland PIMS v3.0 and the capabilities of the newest module,” said Caroline Dugopolski, Histogenics’ Vice President of Technical Operations. “This release provides a comprehensive data management package that supports process knowledge management and CPV using robust data integrity controls within a centralized, validatable environment.”
“Skyland software development team truly understands manufacturing data management”
