ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Pediatric Dosage Form Development: Program Design And Formulation Development

  Explore key considerations to successfully bridge from initial concept of pediatric program design and formulation development strategies into later stages of development and through to commercialization.

• Off-The-Shelf Vs. Novel Devices: Selecting A Drug Delivery System

  Whether bringing a novel therapy to market or altering current devices, companies must determine the best selection for administration without impacting drug efficacy, quality, and safety.

• Strategies For Accelerating The Development Of Modified Release Oral Forms

  Careful selection of appropriate excipients and delivery technologies is key to the design of modified release (MR) formulations fulfilling specific performance requirements.

• Addressing Glass Particulates In Injectable Drug Formulations

  Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.

• FAQs On The Revised EU GMP Annex 1: Volume 8

  Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.

• Gliding Towards De-Risked Combination Product Development

  Learn about the critical role plunger stoppers play in determining a combination drug product's exposure to extractables and leachables.

• Device Design For Usability And Risk Reduction

  Growing use of large‑volume subcutaneous therapies is increasing demand for wearable injectors that reduce user error, simplify preparation, and enhance safety through human‑factors‑focused design.

• Steps To Overcome Challenges Associated With Biologic Formulation Development

  Explore guidance on the challenges posed by biologics, including overcoming degradation, establishing a stress test process, and the value of lipid nanoparticles (LNPs) and polymeric nanoparticles (NPs).

• Patient Adherence With A Novel Dosage Form

  A sprinkle formulation helps patients with tremors or dysphagia take medication more easily, improving adherence, comfort, and care through a novel, FDA-approved oral granule format.

• Meeting Annex 1: A Proactive Approach To Regulatory Compliance

  It was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.