ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Containment Solutions To Help Emerging Biologic Companies

  Set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.

• Applying Automation To The Manufacture Of Drug Delivery Devices

  Automated manufacturing is a powerful but often misunderstood tool available to produce drug delivery and other pharmaceutical devices — whether established designs or innovative new ideas.

• How To Protect A Modern Silicone Oil-Sensitive Biologic Drug For Self-Injection Of 2.25mL

  A customer experienced expensive project delays when they selected their “tried and tested” large volume, glass syringe system to package a drug to be used in an auto-injector for self-administration.

• 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.

• Is Your Combination Product Drug-Led Or Device-Led?

  The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• Navigating Large-Volume Subcutaneous Biologic Injections

  Large-volume subcutaneous delivery is bringing biologic treatments closer to patients. Learn how advances in dosing and device technology are shaping care.

• Gliding Towards De-Risked Combination Product Development

  Learn about the critical role plunger stoppers play in determining a combination drug product's exposure to extractables and leachables.

• 5 Novel Techniques For Solubility Enhancement

  Thanks to insoluble drug delivery technologies, the practice of reformulating poorly soluble drug products to improve efficacy, patient compliance and safety has now been widely adopted.

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  All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.