Articles, App Notes, Case Studies, & White Papers

  1. Using FT-IR To Identify Contaminants In Drug Delivery Systems & Combination Products 3/7/2024

    Learn how formulation, device, quality, and engineering teams can strengthen contamination-control strategies, improve delivery reliability, and reduce product-quality risk throughout the drug-delivery lifecycle.

  2. Maintaining Superior Viral Vector Recovery In Cell And Gene Therapy Applications 9/3/2024

    A study assessing the stability of vials aimed to determine if the vial material had any influence on the viral titer and particle counts of the AAV serotypes.

  3. The Algorithm Is In: 5 Ways AI Is Transforming Medicine 1/17/2024

    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.

  4. Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1 2/4/2026

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

  5. 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.

  6. Spray Drying: Advantages And Disadvantages 2/28/2022

    When it comes to formulation development, pharmaceutical spray drying is one of the most versatile solutions. Review a detailed look at the steps involved in spray drying and the benefits and downsides.

  7. Lyophilization vs. Liquid Formation: Why Lyo Offers Advantages 3/8/2022

    Lyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.

  8. Annex 1 – The Brave New World Of Regulatory Compliance 2/3/2023

    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.

  9. New Polymer Overcomes Limits In Sustained Drug Delivery In Ophthalmology 3/29/2023

    Challenges specific to eye physiology complicate the development of new therapies and necessitate innovative drug delivery methods. Biodegradable polymers show promise in addressing these challenges.

  10. Effects Of Annex 1 Revisions On Manufacturing Operations 12/1/2022

    The revisions to EU Annex 1 set the stage for the future direction of the pharma/biotech industry. Explore some of the key takeaways and interesting changes for risk management and contamination control strategies.