ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• How To Leverage Modeling And Simulation In The Candidate Development Stage

  Modeling and simulation provides another way to predict the clinical performance of a molecule, based on a robust and holistic approach, before investing the required time and money.

• Seven Softgel Myths: Are You Missing Your Softgel Opportunity?

  Softgels are a popular dose format among consumers, thanks to their high swallowability and quick onset of action, yet pharmaceutical developers may not even consider them. Why the disconnect?

• A Smart, Data-Driven Approach To Formulate Biotherapeutics For PFS

  Explore a unique model to predict injection force designed to decorrelate factors linked to formulation development and the ones linked to container and delivery device selection.

• Enriching Sterile Fill/Finish Services With A Patient-Centric Approach

  Through early collaboration and advanced aseptic technology, organizations can overcome complex formulation challenges to ensure safe, effective treatments reach patients more efficiently than before.

• Gaps In Reconstitution Process Filled By Water-For-Injection Syringe

  The recent rise in biopharmaceutical drugs has sparked renewed interest in lyophilization as a way to bring injectable biologics and other drugs to market more quickly.

• Making A Case For A Fixed Dose Combination Drug Strategy

  As patient-centricity spurs innovation in drug delivery systems, examine the potential of FDCs to provide convenient dosing and how increased patient compliance is alleviating the cost of health care.

• High-Performing Ionizable Lipids For Controlled Nucleic Acid Delivery

  Ionizable lipids are central to effective mRNA delivery, influencing potency, biodistribution, and toxicity. See why advancing delivery beyond the liver will require stronger structure-function insights.

• Advances In Spray Drying For Enhanced Bioavailability And Improved Formulation Control

  In a recent webinar, Lonza discussed the process it uses to develop a spray dried powder formulation and scale from early feasibility studies to manufacturing.

• De-Risking Visible Particles Through Component Selection

  Explore a summary of the FDA’s recent draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components.

• Procuring Packaging And Delivery Systems: Single Versus Dual Sourcing

  In this article, Fran DeGrazio examines the trend toward dual sourcing of products, components, and materials for drug delivery packaging and systems. She outlines the key differences between single and dual sourcing and makes recommendations about using one versus the other while mitigating supply chain and product quality risk.