ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• From Regulators To PUPSIT: Notes On Annex 1 Revision Implementation

  Kevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.

• Delivering Child-Friendly, Broad-Range Dosing For Toddlers

  A European-based pharmaceutical company wanted to improve their pancreatic enzyme product (PEP) delivery to patients who have difficulty swallowing several capsules a day – especially children with cystic fibrosis and other conditions.

• Selecting A CDMO For Custom Activated PEGs

  Custom-activated PEGs require thoughtful planning and precise analytical control. Discover key considerations for selecting a partner capable of supporting scalable, compliant PEGylation.

• Innovative ASD Technology Improves Abandoned Cancer Medication

  Review this case to learn how one solid dispersion technology lowered patients' pill burdens and demonstrated an improved therapeutic response for Galeterone.

• A Robust Extractables Data Package Helps Drive Patient Safety

  Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

• Safely Navigating The Transition From MDD To MDR

  If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

• Designing Delivery Devices For Older Adults With Cognitive Impairment

  Leverage our insights to improve your human factors studies and ensure the effective inclusion of older adults with mild cognitive impairment.

• A Step Change In Pharmaceutical Glass Packaging Innovation

  Valor Glass represents a significant, and much needed, step forward for glass innovation. Review the findings and learn how an aluminosilicate formulation can lower your glass vials' extractables profile.

• Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products

  As the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.

• Avoiding The Pitfalls Of LNPs And Complex Formulations

  Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.