ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• Solid Form Screening, Rapid Formulation Selection To Meet Tight Timelines

  A comprehensive approach to evaluating drug molecules for the selection of a lead solid form and formulation can significantly accelerate development timelines and limit risks in later development.

• Meeting Annex 1: A Proactive Approach To Regulatory Compliance

  It was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.

• Is The Autoinjector Dead? The Future Of Patient-Centered Drug Delivery

  Autoinjectors revolutionized drug delivery, but innovation is shifting toward oral, wearable, and alternative platforms. Future focus emphasizes patient experience, sustainability, and broader drug delivery toolkits beyond the autoinjector.

• Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization

  While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.

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

  The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, which aim to minimize contamination and ensure patient safety.

• Elastomer Plungers With Barrier Film For COVID-19 Vaccines

  Minimize the risks of accelerated drug development processes and the potential use of new vaccine platform technologies with the use of an elastomer plunger laminated with FluroTec™ barrier film.

• The Challenges And Opportunities Of Real-World Evidence

  The FDA's Real-World Evidence framework addresses challenges in using Real-World Data for regulatory decisions, emphasizing data reliability, bias management, and successful case studies.

• Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

  This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.

• 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.