ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Self-Injection Of Biologics Made Easy

  Ready-to-Use (RTU) 3mL cartridge-based, single-use Pen Devices are specifically designed to ensure consistency of delivery for high-volume, high-viscosity injectable drug delivery systems.

• Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics

  All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

• Less Mess, Less Stress, Best Expressed: An Alternative To Spray Drying

  Although well-established processes, spray drying and hot-melt extrusion can be outperformed in bioavailability, cost-savings, manufacturing speed, environmental impact, and more.

• Combining Gene Therapies, Carrier Systems, And Medical Devices

  Drug delivery is one of the most significant obstacles to advancing gene therapies. Examine the opportunities for success in combining novel medical devices to improve delivery of gene therapies.

• Using Advanced Technologies To Formulate Complex Molecules

  In this survey, 200+ people involved in the oral dose market shared their views on barriers to the development of oral formulations and technological responses to them.

• Zero-Stress Low Volume Aseptic Filling For Solids And Liquids

  Aseptic filling technology is of utmost importance. Explore in great detail an aseptic filling solution that has been specifically designed for laboratory and R&D applications in the pharmaceutical industry.

• Nanoparticle Engineering Addresses The Challenge Of Poor Aqueous Solubility

  As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.

• 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.

• Lyophilized Products Are On The Rise: What You Need To Know

  There is increased demand for lyophilization services in the manufacturing of new biologic drugs and injectable formulations as well as in change of formulation presentation.

• Crystallization Process Dev: Ramping Up Bench-Scale Control

  Since physical structure and biological activity are directly linked, controlling the physical form of a compound is paramount to a final drug product’s quality and effectiveness.