ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Key Considerations For Packaging Solutions For Cell And Gene Therapies

  Thinking of packaging and delivery factors early and often will minimize risks to the safety and efficacy of your cell and gene therapy drug product from the bench to the patient.

• Achieving EU GMP Annex 1 Compliance For Contamination Control

  Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.

• Overcoming Limitations To Achieve Uniform Dosing

  An immediate need for lower dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery.

• Navigating Regulatory Challenges In Oligonucleotide Therapeutics

  Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.

• Maximize Global Regulatory Collaboration

  When marketing a combination product globally, pharmaceutical manufacturers and drug delivery technology providers must have a collaborative infrastructure based on strategic alignment, proactive regulatory awareness, lifecycle support, and continuous improvement globally.

• How MedTech And Pharma Are Responding To Rising R&D Pressures

  MedTech accelerates innovation through acquisition and integration while pharma sustains research depth by distributing risk and cost. These distinct paths are reshaping product development.

• Supporting Complex Manufacturing For Liquid And Lyophilized Drug Products

  Aseptic fill and finish operations gain efficiency and precision with modular isolator technology, inline weight checks, and lyophilization, which are ideal for mRNA-LNPs and other sensitive modalities.

• Key Considerations When Filling Dual Chamber Syringes

  Dual-chamber syringes (DCSs) are in high demand across the pharmaceutical and hospital industries. Learn about the challenges of the DCS filling manufacturing market and how to overcome them.

• Developing And Manufacturing Drugs With HPAPIs

  Learn why companies must invest in specialized expertise to develop scalable, safe, and efficient manufacturing processes for highly potent oral solid dose products.

• Improved Biomanufacturing Processes And Drug Product Stability

  Improve upstream media for bioavailability and foam stability, downstream buffers for purification, and the formulation and final fill drug product stability with this highly interdisciplinary process.