Outsourced Pharma White Papers

  1. Buffer Management Solutions For Large-Scale Bioprocessing
    2/1/2018

    How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.

  2. Scalable Strategies For Parenteral Dosage Form Selection
    12/29/2017

    Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.

     

  3. Multiplexing: Managing Risk With Proven, Single-Use Solutions
    11/27/2017

    With many uncertainties when introducing a new drug to market, seeking manufacturing flexibility to accommodate diverse demands and production needs is key.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Pharma Production Tech 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.

  10. 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.