Therapeutic ChallengeRegulatory Hurdles
Manufacturability, consistency, and safety are central to successful regulatory approval. Likarda’s CSS® technology is designed with these principles in mind, leveraging starting materials that are FDA GRAS (Generally Recognized as Safe) and highly biocompatible, which reduces the burden of toxicology testing and accelerates the regulatory pathway. The platform is standardized, scalable, and closed-loop—supporting GMP production, consistent quality control, and streamlined approvals for both autologous and allogeneic therapies.
Two distinct regulatory pathways apply depending on use case:
LogisticsAegisCell™ & LiberaCell™
- Ancillary products in the manufacturing process
- Residual and degradation product analysis
- Toxicology range analysis for degradation enzyme
- GMP manufacturing requirements
TherapeuticEnduraCell™, VitaCell™, ViscoCell™
- Function as excipients, many already on GRAS or FDA’s Inactive Ingredient List
- Rigorous biocompatibility testing
- Demonstrated no effect on active ingredient
- Evaluated with the active ingredient for toxicology, efficacy, and PK/PD
By structuring regulatory pathways in this way, Likarda enables developers to align early with FDA expectations, streamline preclinical safety testing, and reduce risk in both logistics- and therapeutic-focused applications.
