Outsourced Pharma App Notes & Case Studies

  1. The Right Biomanufacturing Partner Can Improve Flexibility And Mitigate Risks From Forecasting
    7/21/2016

    While forecasts can never be 100 percent accurate, the goal for biopharmaceutical forecasters should be to minimize the degree of inaccuracies as much as possible.

  2. How Biogen Integrated PAT With End-To-End Supply Chain Transparency
    10/2/2018

    To drive dependable critical process control requirements, Biogen explored novel strategies to increase process and raw material control and optimize communication of data throughout the supply chain.

  3. Downstream Process Development For Efficient Purification Of Adenovirus
    9/10/2018

    Here, we describe the development of two effective downstream processes for purification of adenovirus from cell culture harvest.

  4. Getting Ready For Phase 1 In Pharmaceutical Development
    4/11/2017

    At the early stages of product development, pharmaceutical development scientists are under increasing time pressure to select the right molecule form, the right formulation and the right final dose form.

  5. Is Selecting A CDMO Based On Contract Price Really Saving You Money In The Long Run?
    11/16/2017

    Before you sign on the dotted line, do a little digging to unearth potential costs that could turn your development program into a cash-burning exercise.

  6. Comparing Recombinant Protein Production With A Shake Flask And A Bioreactor
    10/26/2016

    This application note compares cell growth and recombinant protein production of multiple Chinese hamster ovary (CHO) cell clones when cultured in HyClone ActiPro basal medium and Cell Boost 7a and 7b feeding supplements.

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

    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 to avoid microbial contamination.

  8. Digital Manufacturing Of Biologics
    2/19/2019

    In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. 

  9. Embrace Quality Risk Management To Build A Strong Quality Culture
    6/3/2016

    Using QRM gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.

  10. Optimizing Elution Conditions On Capto MMC Using Design Of Experiments
    10/22/2007

    The multimodal ligand of Capto™ MMC generally requires elution conditions that diff er from those used with traditional ion exchangers. This application note describes how Design of Experiments (DoE) can be used to optimize elution conditions and thus recovery of a target protein