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.

• Overcoming Wet Injection Challenges With Human-Centric Design

  By understanding the causes of wet injections and employing effective mitigation strategies, we can design safer, more user-friendly, and more effective devices.

• Impact Of Post-Covid Literacy Decline On Medical Device Studies In Youth

  Examine the challenges of using traditional human factors methodology with young individuals whose literacy levels have declined compared to historical data.

• Decoding the FDA Guidance on Essential Drug Delivery Outputs

  The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.

• Considerations In Formulation Development Of Injectable Solutions

  Injectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.

• Strategies For Accelerating The Development Of Modified Release Oral Forms

  Careful selection of appropriate excipients and delivery technologies is key to the design of modified release (MR) formulations fulfilling specific performance requirements.

• Accelerate Development Of Enabled Formulations For Poorly Soluble Drugs

  Explore how a platform integrating drug substance, drug product, and clinical testing within a single organization accelerates development and reduces costs, helping deliver positive outcomes earlier.

• Annex 1 – The Brave New World Of Regulatory Compliance

  The revision to Annex 1 will become effective in August 2023. Explore the major changes and considerations along with the next steps to achieve Annex 1 Regulatory compliance.

• 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.

• FAQs On The Revised EU GMP Annex 1: Volume 3

  The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.