ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• How Devices, Instructions, And Packaging Work Together To Improve Safety

  A medical device's user interface is the entire product system: the device, labeling, packaging, and IFU. These elements are crucial for risk mitigation and must be tested holistically.

• The Algorithm Is In: 5 Ways AI Is Transforming Medicine

  AI is transforming the medical field, offering innovative solutions to complex problems. Explore the potential of AI in revolutionizing healthcare and leveraging data to improve patient experiences.

• Streamline Your Fill And Finish Process Of Ready-To-Use Cartridges

  An optimized nest design for pre-fillable cartridges was designed using numerical simulation and data analytics to improve efficiency in pharmaceutical production.

• How To Find The Right Balance In Cell Therapy Manufacturing

  The choice between closed and open fill/finish for cell therapy drug products ultimately involves a careful balance between safety, accessibility, efficacy, and the type of cell type used.

• 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.

• Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations

  The study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.

• Nanosuspension Dosage Forms: Product Development & Scale Up

  For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.

• Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products

  As the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.

• Rational Design Of Oral Nanosuspensions For Insoluble Drugs

  The advantages of nanosuspension dosage forms include improving bioavailability and API stability, increasing drug loading, better dose flexibility and accuracy, and easy swallowing for pediatric or geriatric populations.

• Vial Adapter Considerations For Cell And Gene Therapy Applications

  Review features that need to be considered to choose a vial adapter for cell and gene therapy drug products and a case study where vial adapter transfer devices have been used to extract lentiviruses.