Outsourced Pharma White Papers

  1. Navigating CMC Regulation For Plasmid DNA In Gene Therapy 5/28/2025

    Explore how evolving regulatory pathways and CMC innovation are shaping the future of gene therapy and viral vector production, plus what to consider when selecting a CDMO partner.

  2. Stopper Migration In Frozen Pre-Filled Syringes 10/16/2024

    Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.

  3. Single-Use Innovation For The Future Of Therapeutic Manufacturing 1/28/2025

    Gain insight into these end-to-end plasmid DNA solutions, leveraging robust cGMP-compliant processes and single-use manufacturing platforms to accelerate your cell and gene therapy programs.

  4. Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing 8/22/2024

    Testing for nitrosamines is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.

  5. Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap 7/23/2025

    As biopharma complexity grows, flexible CDMOs are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.

  6. Preparing For Disease X: Effective Vaccine Development In The Face Of A Future Pandemic 5/8/2024

    CDMOs are playing a critical role in the global effort to prepare for future pandemics. Learn how innovative strategies and flexible platforms are helping to ensure a swift and effective response plan.

  7. How To Avoid Sticking And Picking In The Tableting Industry 9/23/2024

    Review strategies to mitigate sticking and picking risks in the tablet industry, and learn how you can foster improved tablet production processes, ensuring higher quality and consistency.

  8. Set Your Cell And Gene Therapy Program Up For Success From Day One 9/25/2024

    Partner with a specialized CDMO early in your CGT development to ensure a streamlined path from discovery to successful commercialization, avoiding costly pitfalls and delays.

  9. 5 Steps To Design A Microbiological Performance Qualification For Facilities 4/21/2025
    Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
  10. Cell Line Development: The Linchpin In Biotherapeutic Development 1/4/2024

    Review key factors for building a reliable CLD strategy, and learn how the right CDMO can help you achieve the high quality, high yield, and speed needed to successfully bring a biologic to market.