ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Formulation Considerations For Pediatric Populations

  By partnering with a CDMO with experience in pediatric formulation, pharmaceutical companies can increase acceptability of their drugs among pediatric patients.

• 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.

• Prioritize Safety And Mitigate Risk In HPAPI Manufacturing

  As highly potent active pharmaceutical ingredients become increasingly common across the industry, it is critical to work with partners who use a risk-based approach to ensure safety and quality.

• Plan For Your Extractables And Leachables Studies To Meet Submission Timelines

  Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.

• FAQs On The Revised EU GMP Annex 1: Volume 7

  Modernize your sterile manufacturing approach. Explore essential insights on contamination control strategies, risk management, and barrier technologies to ensure full regulatory alignment.

• An Insoluble Problem? Oral Drug Solubility With Functional Polymers

  Review the basics of solubility enhancement and the formulation and manufacture of products that enhance solubility and common questions on the topic.

• 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.

• De-Risking A Novel Valve Component For Use With Standard Syringe Systems

  A novel valve provides dual‑chamber functionality within standard syringes, keeping two liquid drugs separated until injection while reducing development risk through advanced modeling.

• Navigating PFAS In Medical Devices

  Review how an experienced partner can help you navigate the shifting regulatory landscape for your medical device.

• 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.