Current trends & considerations for drug delivery device assembly of self-administered products

Current trends & considerations for drug delivery device assembly of self-administered products

04/18/2018, 3:15 PM - 4:00 PM

Technical Conference Stage 1, Booth 1076, Exhibit Hall

Language:
English

A) Post device selection POP (proof of principle) and process development considerations Once the delivery device(s) has been determined for the final delivery of the drug product itself, the suitability of processes and technologies chosen play a critical role in the success of the product once commercialized. However, proper planning and consideration at the earliest stage will ensure that the foundational criticalities are foreseen to ensure successful scale-up, from submission to clinical trials, to meeting the commercial volumes as the projections indicate. Assuring technologies can fulfill expectations from the onset are critical to establish the foundation of success. With a plethora of technical assets available, how to select the right technology partner that can fulfill expectations of knowns and unknowns, will be key to overall success. B) Scalability path to commercialization A sequential step regarding how to apply the process development, POP, and conforming strategies is imperative for proper risk mitigation, especially with interfaces with the regulatory agencies. Creating a strategy that encompasses the overall vision and direction from the onset can be scripted. Methods to avoid limiting flexibility and versatility can be avoided. C) How to maintain the scalability model when multiple device platforms are targeted Capital planning for commercialization are a significant part of the entire process, however dynamic capabilities can be accomplished if the correct philosophy is aligned early with similarly designed solutions. While philosophical discussions historically misaligned with real world "metal" solutions, the technology arena has been evolving towards more user-friendly and multi-product deployment capabilities. Such developments have arrived to utilize delivery device platforms within the same innovators' family or products or even across different innovator product lines. There are now solutions to realize the utmost flexibility and versatility.

Contributors

  • Anders Hermansen

    Speaker

    International Sales Manager, Drug Delivery Device Assembly Equipment

    Robert Bosch Packaging Technology

  • Erik Knight

    Speaker

    Drug Delivery Device Assembly Technology, North American Product Manager

    BOSCH/Robert Bosch Packaging Technology

    A bit of a rarity in the capital equipment space, Erik has a vast experience in pharma and biotech since the early 90's when he started in the...

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. Understanding the possible methods and approaches to perform POPs (proof of principle) and process development to ensure repeatability and conformance 2. Understanding the criteria to plan a scaleable commercial path for assembled drug delivery devices 3. How to plan a commercial launch of a drug delivery device when multiple devices are targetted

Categories

  1. Track
    Optimizing Facilities through Innovation & Technologies

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