For speed and flexibility in clinical trials

For speed and flexibility in clinical trials
Product Description

Haselmeier's D-Flex(TM) platform is the ideal choice for use in clinical trials and beyond, supporting you from drug development, through clinical trial, to commercial market launch. A complete solution offering for pharmaceutical companies and biotech start-ups To be deemed suitable for use in clinical trials, injection pens must be safe and simple to use, as well as supporting flexibility in the adjustment of the dose in phases 2 and 3. In addition, these devices must support continuous use with minimum adjustments for all phases of the clinical study up to drug approval. The D-Flex(TM) product platform can be configured for several fixed doses and values can be freely selected, making the device especially useful in dose-escalation studies, for example. The pen system does not allow any intermediate steps between the set doses, significantly reducing the risk of an incorrect dose and therefore supporting patient safety. Moreover, the D-Flex(TM) product platform pen can be quickly and cost-efficiently adjusted to meet customer requirements in terms of clinical-trial design, by replacing just one single part of the device. Modifications after phase 2 are possible and the drug delivery device can be adjusted to the requirements of other products in the drug development pipeline.

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Haselmeier GmbH

  • DE
  • 2021
    On CPHI since
  • 3
    Certificates
  • 250 - 499
    Employees
Company types
Drug delivery device Supplier/Manufacturer
Engineering
Manufacturer/Innovator
Primary activities
Medical Devices
Packaging & drug delivery
View company profile
Categories
more categories Show less

Haselmeier GmbH

  • DE
  • 2021
    On CPHI since
  • 3
    Certificates
  • 250 - 499
    Employees
Company types
Drug delivery device Supplier/Manufacturer
Engineering
Manufacturer/Innovator
Primary activities
Medical Devices
Packaging & drug delivery
View company profile

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Haselmeier GmbH resources (4)

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    In this webinar, originally broadcast as part of Pharmapack Europe 2022, Chris Muenzer, Vice President of Innovation & Development, Haselmeier, a medmix Brand discusses how development of an integrated drug delivery device is a complex exercise that requires expertise in medical device engineering and pharmaceutical science. Health authorities expect legal manufactures to have a strategy to control device performance through the entire supply. Modeling and simulation is an important tool to ensure robust and repeatable performance while maintaining time to market. This case study looks at how Haselmeier is applying these techniques during the creation of a new autoinjector platform. In addition, Chris will look at future opportunities for further improvements though expanded use of digital twins and other technologies.
    2023-01-24
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    PiccoJect™ is a highly compact, customizable and fully featured two-step autoinjector designed for subcutaneous delivery of drug products.Extremely low part counrtLarge wrap-around drug window with customizable sizeOptimized spring forcesFuture proofCommitted to sustainabilityErgonomic shape & small sizeColored status indicatorAudible clicks at the start and end of injectionAny standard 1 ml or 2.25 ml pre-filled syringeA full-service platform
    The products shown in this video are under development and some of them may not yet have been approved for sale under applicable medical device regulations. The concept provides general information about these products, their field of application and intended use, and their function, performance and specification are subject to customer specific development and may deviate from those shown herein. All information contained herein is directed at medical device manufacturers and pharmaceutical companies. This information shall not constitute a promotion for use in a way which conflicts with any applicable medical device regulations, nor is it directed at patients or intended to replace professional medical advice.
    2022-08-04
  • Sustainable Drug Delivery: The Device Supplier's Perspective

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    This session will explore: The role of the device supplier in overall product sustainability Benefits of lifecycle assessment (LCA) in device development Trade-offs between usability, cost of goods, and carbon footprint Challenging Pharma to close the circle and enable better solutions
    2024-02-02
  • Advanced Delivery Device Technology to Simplify the Reconstitution of Lyophilized Drugs

    Webinar Advanced Delivery Device Technology to Simplify the Reconstitution of Lyophilized Drugs

    Lyophilization (freeze drying) is a proven process for increasing the shelf life of vaccines, biologics and other injectables. But delivering these products requires several use steps that make them challenging to administer, particularly by patients and caregivers in non-clinical settings. To address these needs, Haselmeier has been developing several solutions for an easier and more convenient reconstitution and administration. This presentation will cover different types of primary drug containers such as vials and dual chamber cartridges for reconstitution along with the available device solutions to simplify delivery. The challenges and advantages of each solution, including vial to cartridge, out-of-pen reconstitution, and in-pen reconstitution will be discussed.
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