Outsourced Pharma White Papers

  1. Rational Design & Development Of Long-Acting Injectable Dosage Forms 1/26/2022

    The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.

  2. Bulletproof Supply Chain: Hope For The Best, Prepare For The Worst 8/3/2021

    How to incorporate flexibility in planning to overcome potential challenges, the value of having a contingency plan, and how a risk-based approach can determine where a contingency plan is needed.

  3. Annex 11: The EU’s New Expectations For Regulated Computerized Systems 8/27/2021

    The Annex 11 Guidance is for the lifecycle of computerized systems to reflect the increased use and complexity of automated systems in the pharmaceutical industry. In this paper we cover the Scope of Annex 11, it's impact on medical device companies and its role in inspection readiness.

  4. Placing Drug Strategies On A Solid Foundation For Success 4/21/2022

    Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.

  5. 9 Pitfalls To Avoid During The Document Control Process 8/23/2021

    In order for the document control process to be a smooth ride to a successful product launch, you need effective control in every phase of the life cycle of every important document. In this white paper, we discuss common issues in every phase of the life cycle of a document.

  6. Understanding Of Amorphous Solid Dispersions & Their Downstream Development 2/7/2022

    Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.

  7. Bridging The Gap: Manufacturing Software And The Paperless Imperative 9/2/2021

    Despite the many advantages of digitizing, automating and integrating manufacturing management systems, the truly paperless factory floor remains an elusive goal for most companies. This paper provides a summary and comparison of the leading manufacturing software solutions available today, discusses selection considerations given their strengths and shortcomings, and presents a vision of what manufacturers need to achieve a truly paperless production floor in their pursuit of manufacturing excellence.

  8. Outstanding Sensitivity For Confident SPR Interaction Analysis 7/20/2022

    Explore how surface plasmon resonance (SPR)-based analyses with a high sensitivity instrument can provide greater data precision and better confidence in your results interpretation.

  9. Navigating Regulatory And Development Milestones 9/17/2020

    This article addresses how early-stage biotherapeutic companies can avoid common pitfalls as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.

  10. Downstream Process Intensification For Virus Purification 9/9/2020

    An overview of the challenges presented by current approaches to virus production and a platform approach that can work across different viral modalities and accelerate process development.