ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• A Taste Masked And Easily Swallowed Malaria Drug For Elderly Patients

  Dysphagia impacts treatment compliance and disproportionately affects the elderly. Learn how microencapsulation enabled formulation of a water-soluble powder drives patient adherence.

• Container Closure Integrity: A Risk-Based Approach

  Container closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.

• Lyophilization: Protecting And Preserving Biologics

  Discover how lyophilization revolutionizes biologic drug manufacturing and ensures potent, stable treatments for complex diseases.

• Customized Release Through Dispersed Dosage Formats

  Typically, dosage format is based on the target product profile: how the developer envisions the product best addressing a clinical indication by maintaining population-wide efficacy.

• Developing A Multi-Drug Combination, Antiparasitic Drug For Dogs

  Discover how it worked to manufacture clinical supplies of flavored tablets with multiple APIs in just six months while ensuring content uniformity and stability.

• 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.

• Mitigating Hidden Risks: Extractables And Leachables

  Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.

• De-Risking The Transition From Vial To Drug-Device Combination Product

  When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.

• A Practical Packaging Components Checklist For Emerging Biotechs

  A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

• FAQs On The Revised EU GMP Annex 1: Volume 2

  Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.