ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• The Largest LOE Event In US Pharma History

  Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.

• Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway

  Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.

• From Innovator To Partners In Cell Therapy: Our Evolution Into A CDMO

  Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

• Effects Of Annex 1 Revisions On Manufacturing Operations

  The revisions to EU Annex 1 set the stage for the future direction of the pharma/biotech industry. Explore some of the key takeaways and interesting changes for risk management and contamination control strategies.

• Functional Performance Of Stoppers To Support Multipuncture Use

  Multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight and can create efficiency and reduce packaging waste when vaccines are administered to large populations.

• Drug Formulation Development: Quick Reference Guide

  This guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.

• Rational Design Of Oral Nanosuspensions For Insoluble Drugs

  The advantages of nanosuspension dosage forms include improving bioavailability and API stability, increasing drug loading, better dose flexibility and accuracy, and easy swallowing for pediatric or geriatric populations.

• 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.

• Semi-Solid And Semi-Liquid Dosage Forms: What To Know

  Interest in semi-solid dose (SSD) forms has been on the rise. Learn more about the advantages of formulating medications into SSD forms as well as the challenges to consider.