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.”

Histogenics

“Skyland software development team truly understands manufacturing data management”

Histogenics