ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Why 'Off-The-Shelf' Devices Do Not Circumvent Design Controls

  Utilizing off-the-shelf (OTS) devices for drug delivery can offer significant advantages to development programs in timeline and risk mitigation. Understand the design control responsibilities of a sponsor when using OTS devices.

• Finding The Ideal Balance — Where Risk And Cost Of Quality Meet

  It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.

• Responding To Trends In Prefilled Delivery: Component Assessment And Selection

  Existing plunger technology for PFS was developed for manual injection and does not meet the evolving requirements for drug delivery especially for consistency of injection rate.

• Developing An Effective Lipid Nanoparticle Formulation Process For Small Molecule And Biologicals Delivery

  Lipid nanoparticles (LNPs) are a versatile formulation technology used by drug development teams to deliver a variety of small/large molecules, peptides, and biologicals.

• Autoinjectors: A Revolutionary Leap In Drug Delivery

  Explore how the widespread adoption of autoinjectors is transforming the biopharmaceutical industry's approach to drug delivery, offering precise dosing, patient adherence, and safety.

• Is The Autoinjector Dead? The Future Of Patient-Centered Drug Delivery

  Autoinjectors revolutionized drug delivery, but innovation is shifting toward oral, wearable, and alternative platforms. Future focus emphasizes patient experience, sustainability, and broader drug delivery toolkits beyond the autoinjector.

• Unlocking A Patient Preference For Rapid Onset In Treating Migraines

  Examine the case study and learn how formulating an orally disintegrating tablet (ODT) created a convenient dosage form with a shorter T_max for the treatment of acute migraine.

• Packaging/Delivery System Integrity And Self-Sealing Capacity Of Vial Systems

  Review the scope and testing procedures required by General Chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems.

• Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations

  The study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.

• Integrated First-In-Human Services To Streamline End-To-End Development And Manufacturing

  Lonza’s SimpliFiH^®️ Solutions offering is designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.