A novel approach to wallet card design & manufacturing helps an innovator avoid costly Phase III study delays.

A global biopharmaceutical company sponsored a Phase III, randomized, double-blind study to gain approval for extending its commercially available therapeutic product to a new patient population.

While the biopharmaceutical company had conducted early phase trials in the US using a relatively simple clinical packaging approach, entering a global Phase III trial presented fresh challenges.

THE CHALLENGES

For the sponsor’s Phase I and II trials, a single-dose pill bottle format was used. However, regulatory and logistical hurdles forced an immediate alternate packaging design for the Phase III trial.

Following extensive consultation with CalCog, it was determined a wallet card system would be a more suitable approach. This presented further complexities, including:

  • The trial drug supply relied on drug product packaged in a commercial configuration rather than being designed explicitly for blinded clinical use.
  • The blister strips had identifying marks making them unsuitable for blinding and mixed dosing.

  • The drug product was brittle and heat sensitive, eliminating the option of utilizing a standard wallet card and sealing process.

    OUR SOLUTIONS

    CalCog’s ability to solve complex and unusual challenges lies in our extensive experience developing highly creative solutions within regulatory parameters. This project required considerable collaboration with packaging partners to facilitate the multiple design-test iterations and maintaining close vendor relationships was crucial.

    To overcome the wide-ranging packaging challenges of the trial, CalCog developed a novel design and manufacturing approach using a blister strip that was initially incompatible with a wallet card enclosure. CalCog’s solution included the following:

    • Designing a wallet card with a unique peel-and-drop lidding mechanism to protect the brittle tablet from excessive pressure when removing from the blister.
    • Masking of all identifiable markings from the blister strip, allowing the investigational drug product and placebo presentation to be indistinguishable.
    • Printing of unique graphics directly onto the wallet to provide patient-friendly dosing instructions.
    • Developing a blister card sealing process to accommodate the product’s heat sensitivity.
    • Implementing a bespoke wallet design validation process to ensure the drug product’s temperature remained within an acceptable range during wallet sealing.
    • Creating packaging to conform to country specific child-resistant packaging.

    PROGRAM OUTCOMES

    Advanced Phase III study within targeted timelines.

    Remained within client’s established study budget.

    Designed a bespoke wallet & manufacturing process.

    Maintained compliance with all global regulatory requirements.

    “We realized that devising a clinical packaging solution for this trial would require quite an effort. However, CalCog has worked within regulatory constructs to creatively solve many clinical supply problems for us in the past. I knew they would rise to the challenge, and they did.”

    –Executive Director, Clinical Supply Operations, Biopharmaceutical Innovator

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