Outsourced Pharma White Papers

  1. Secure The Cell Therapy Supply Chain From Bench To Bedside 10/4/2021

    While current approaches can manage the existing volume of cell therapy shipments, scaling these treatments up and out will increase pressure on cryogenic logistics networks. 

  2. 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.

  3. 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.

  4. Accelerating Cell Line And Process Development 8/27/2020

    This paper describes rapid identification of high-producing cell lines, media feed optimization, and a bioreactor scale-up approach for consistent, reliable upstream bioprocess development.

  5. 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.

  6. Enabling Perfusion Processes With Cell Retention Technologies 7/15/2020

    In this white paper, we explore various strategies for the intensification of upstream perfusion processes with cell retention technologies and the viability of each solution.

  7. Getting Your Investigational Drug Regulatory Ready 12/1/2020

    Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.

  8. A Molecule’s Journey: Break Down Roadblocks To Commercial Manufacturing Success 3/18/2022

    Our experts share key considerations for biopharmaceutical companies as they advance to commercial manufacturing and navigate complexities associated with business planning, process scale-up, optimization and validation, technology considerations and regulatory compliance.

  9. Top 8 Obstacles In Pharma & Biologics Products Registration & Submission Management 8/24/2021

    Life science organizations can’t afford any delays in product registrations and overall time to market. As with many industries, time is money. There are a variety of obstacles that result in delays to registrations, many of which can be avoided using sound business processes and leveraging technology to automate processes. Here we identify some of the most common problems below and share some insights on how best to address them.

  10. Quality By Design And Design Control Roadmap For Combination Products 11/30/2020

    Quality by design (QbD) principles help to facilitate design of products and processes that maximize the product’s efficacy and safety profile while enhancing product manufacturability.