Outsourced Pharma White Papers

  1. The Race to Phase III: A Cautionary Tale of Scalability
    10/30/2017

    Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.

  2. Insights And Tips When Addressing Bioburden Challenges
    8/30/2017

    This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

  3. Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing
    8/30/2017

    A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.

  4. Manufacturing Process Scale-Up For Phase III
    8/15/2017

    The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process may be.

  5. Managing Demand Uncertainty In Biologics Production
    8/9/2017

    How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.

  6. Improving Compliance And Manufacturing Efficiency In Life Sciences
    8/7/2017

    Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult. Read on to understand strategies, frameworks and recommendations to achieve these goals.

  7. Leverage The Internet Of Things Within The Laboratory
    8/1/2017

    As science-based organizations look to leverage the internet of things (IoT) within the laboratory, careful consideration must be given to available technologies, data formats, and platforms. 

  8. Pharma Production Technology Transfers: Reaping Rewards, Reducing Risks
    7/24/2017

    Transferring production – and the technologies that undergird it – can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections.

  9. Accelerate Flavivirus Vaccine Production With Modern Bioprocess Tools And Solutions
    6/11/2017

    This white paper gives an overview of modern tools and solutions, adding flexibility and speed to both upstream and downstream operations in flavivirus vaccine production.

  10. Managing Risk In Biomanufacturing
    6/6/2017

    Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.