Aktiv Pharma Group to Participate in the FDA Emerging Technology…

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.

About Aktiv’s Emerging Technology

With the exception of ampules, conventional rigid containers necessitate drug contact materials other than glass, most commonly rubber in elastomeric stoppers/plungers. In prefilled syringes and autoinjectors, interior container walls are frequently coated with silicone to prevent plunger binding and to improve glide. These materials are especially problematic for biopharmaceuticals which are inherently unstable and prone to aggregation and adsorption. Headspace in rigid containers results in a liquid/gas interface that further reduces stability of biopharmaceutical products. By comparison, Aktiv’s flexible film containers do not rely on elastomeric stoppers or siliconized surfaces, reducing the number of drug contact materials to just one, and their headspace can be minimized or even eliminated. Instead of stoppers, Aktiv’s containers utilize permanent, physicochemically bonded film-film closure, which unlike physically mated closures maintains aseptic barrier integrity even at cryogenic temperatures.

One of the key features of Aktiv’s technology is that the flexible containers can be configured with multiple compartments to be merged at the time of use by peeling frangible seals separating them, which enables incorporating aseptic reconstitution/mixing capability into the container itself. This reduces the room for potential user errors and contamination associated with the practice of packaging lyophilized drugs and their diluents into separate vials. It also allows for significantly easier implementation of automated reconstitution/mixing in drug delivery devices.

About Aktiv’s ARAI Autoinjector Platform

The ARAI autoinjector has been developed by Aktiv as a next generation autoinjector platform to address the shortfalls of previous autoinjectors by improving usability, reliability, robustness, and drug stability. ARAI is a versatile platform that can deliver up to 5 ml dose volumes, perform intramuscular and subcutaneous injections, perform simultaneous injections of multiple separately contained drugs, and automatically reconstitute drugs formulated in dry form. Aktiv is currently expanding the ARAI platform to include a consumer market autoinjector for biologics that will feature the same reliability, robustness, and usability benefits in a smaller form factor and with added data connectivity.

About Aktiv

Aktiv is a vertically integrated specialty pharmaceutical company with combination products contract development and manufacturing organization (CDMO) capabilities, that is developing, manufacturing, and commercializing sterile injectable products in a portfolio of proprietary, value-added, glass-free prefilled delivery systems.

Aktiv continues establishing itself as a vertically integrated CDMO with unique combination product competencies specifically targeting biopharmaceuticals. The company’s facilities in Colorado include device development, chemistry, manufacturing and controls (CMC), and manufacturing equipment labs, as well as assembly rooms and sterile fill-finish suites operated under Good Manufacturing Practice (GMP).

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