ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems

  Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.

• FAQs On The Revised EU GMP Annex 1: Volume 1

  The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, which aim to minimize contamination and ensure patient safety.

• MIDBA: A New Regulatory Approach To Clinical Device Bridging

  When devices evolve, evidence expectations can shift. Explore a risk-based clinical bridging approach to support regulatory decisions.

• Decoding the FDA Guidance on Essential Drug Delivery Outputs

  The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.

• Reducing Lead Time & Optimizing Costs

  Explore how the use of this component platform produces significant savings, reduces elastomer SKU complexity, and increases speed to market.

• Vials Vs. Cryobags For Cryopreservation Of Therapeutically Relevant T Cells

  Explore how COP 50 mL vials could serve as a basis for cell therapies and storage solution to help facilitate the manufacture and commercialization of cell products.

• Closing The Care Gap: Clinician Assistive Technologies

  This technology addresses workforce shortages and growing medical complexity by helping healthcare providers manage rising demands, improve efficiency, reduce errors, and extend care access.

• Scaling Safe, Consistent Drug Delivery in Modern Care

   Assistive drug delivery technologies, including wearable injectors, smart infusion systems, and guided delivery tools, help standardize dosing, reduce variability, and expand access across care settings.

• Nasal Inhalation Delivery – An Introduction Guide

  Unlock the potential of nasal inhalation for delivering active pharmaceutical ingredients by exploring the benefits of both liquid and dry powder formulations as companies drive innovation in the field.

• Formulation Research Strategy For Discovery- Stage New Drug Candidates

  Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.