FDA Emerging Technology Program
Broomfield Colorado 6/16/2022. Aktiv Pharma Group (Aktiv) announced today the acceptance of its novel glass-free, film-based flexible primary drug container (PDC) technology for sterile injectables named ARCH, into the US Food and Drug Administration (FDA) Emerging Technology Program (ETP). The ETP is a collaborative effort which supports the FDA’s mission to facilitate modernization in the pharmaceutical industry and helps pharmaceutical companies reduce the time and cost requirements of introducing new, innovative solutions.
The ETP will enable the FDA to establish better understanding of the unique aspects of film-based PDCs and use this insight to develop guidelines and regulations ahead of a broader adoption by the industry. It will also allow Aktiv to communicate with the FDA to create alignment on regulatory, technical, and scientific matters associated with gaining regulatory approvals for Aktiv’s products. “We are excited to participate in this important program and delighted that our technology was recognized by the Agency for its broad potential to improve quality and safety of sterile injectable products” said Patricia Brown, Aktiv’s VP of Quality and Regulatory.
ARCH uses high-barrier polymer films to provide superior performance and increased functionality over conventional glass packaging, either as substitute to vials or when incorporated into prefilled drug delivery systems. ARCH was developed by Aktiv to address potential interactions between biologics and glass-based containers, improve aseptic barriers, provide a superior solution for drugs that require reconstitution at the time of use, and create a foundation for more functional and user-friendly combination products.
The first products to feature the flexible ARCH containers are emergency-use autoinjectors currently being advanced to FDA approval. Aktiv’s autoinjector pipeline includes tranexamic acid (TXA), atropine, pralidoxime chloride (2-PAM), atropine/2-PAM dual-injection, and scopolamine. The flexible container is crucial for achieving the unprecedented ruggedness and reliability of the ARAI autoinjector platform. Aktiv is additionally developing a biologic combination product in collaboration with a leading biopharmaceutical company and planning new products with integrated reconstitution capability.