ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1

  Managing chemical migration from packaging and process equipment is essential to protect patient safety, maintain drug stability, and ensure regulatory compliance.

• Exploring Lipid Nanoparticles For Drug Delivery

  Using lipid nanoparticles (LNP) for drug delivery is a promising area of research. Discover the benefits of LNP delivery, the different types of lipid nanoparticles, their safety for drug delivery, and more.

• 10 Ways To Align Your Medical Device With Human Factors Industry Best Practices

  Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.

• The Growth Of Sterile Injectables

  Learn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.

• 4031 Ready Methods Reduce E&L Timelines

  An established approach for executing extractables and leachables evaluations for individual drug products comprises understanding risks, developing and validating targeted leachables studies, and supporting drug products through stability testing.

• Crystallization Process Development: Peptide Crystallization

  Whether performed during formation of an API or as a means to purify intermediates, achieving control of nucleation and crystal growth is critical to designing a successful peptide crystallization process.

• Selecting An Alternative Coating Technology To Silicone Oil For Prefillable Syringes

  The challenges of silicone-oil lubrication and the growing trend for more viscous, protein-based drugs are now leading pharma and biotech companies to investigate alternative solutions.

• Expanding Opportunities For Inhaled Drug Delivery

  Review the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs.

• Implantable Drug Delivery: Are We There Yet?

  Implantable drug delivery offers precise, localized treatment, yet biological barriers and market complexities remain. Explore the factors determining if these systems are ready for broad adoption.

• FT-IR Identifies Contaminants And Helps Avoid Hazards And Product Loss

  Fourier Transform Infrared Spectroscopy (FT-IR) is a reliable method with multiple applications when it comes to identifying both intrinsic and extrinsic compounds in a drug product.