ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Viral Vector Based Gene Therapy Drug Products: The Right Primary Container

  Explore the major considerations for an ideal primary container for viral vector-based gene therapy drug products and the existing and new solutions in this space.

• Selecting A Vial Container Closure System With The DeltaCube™ Modeling Platform

  Understand a system approach that facilitates data-driven selection and optimization of vial container closure system components.

• How To Find The Right Balance In Cell Therapy Manufacturing

  The choice between closed and open fill/finish for cell therapy drug products ultimately involves a careful balance between safety, accessibility, efficacy, and the type of cell type used.

• Reformulation Of A Complex, High-Drug-Load, Modified Release Dosage Form

  What if you could limit and position a formulation change as only a CMC prior approval supplement under the FDA’s scale-up and post-approval changes guidance?

• Single Source Partner: Seamless Approach To Deliver World-Class Treatment

  Growing demand for high-value, complex therapies requires the right containment and delivery systems: solutions that offer superior quality and patient comfort while meeting stringent regulatory requirements. 

• PHI And Medical Devices: What Device Manufacturers Need To Know

  Connected medical devices must treat Protected Health Information (PHI) protection as integral to patient safety and compliance. Understand the data flows and HIPAA requirements to design security.

• Analyzing Product Formulation Using Raman Microscopy

  Raman spectroscopy is used to compare the dissolution rates and pellet fine structure of branded Sporanox® with three similar generic products marketed across the world, all containing the same API.

• 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.

• Personalized Gene Therapy Is Here. The Next Challenge Is Manufacturing.

  By focusing on approved processes rather than products, the industry can deliver custom genetic therapies rapidly and reliably to patients with ultra-rare diseases.

• Solving The Silicone Challenge In Pre-Fillable Syringes

  Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.