Outsourced Pharma App Notes & Case Studies

81. Automated High Throughput mAb Purification Using Fibro Technology 4/21/2020

    Biomanufacturing is trending towards higher numbers of monoclonal antibody (mAb) projects and smaller batch sizes, with production of most mAbs below 100 kg/yr. These trends are fueling demands to screen more clones faster and improve the efficiency of process development (PD). Read how the Fibro PrismA unit provides a time advantage with comparable recovery and product quality attributes to resin-based column.

82. Purifying Tagged Proteins Using ÄKTA Go Protein Purification System 2/3/2020

    ÄKTA go is a small and compact liquid chromatography system that allows researchers to perform routine protein purification with ease while allowing for efficient use of bench and cold cabinet space.

83. Technology Selection To Enhance Bioavailability 7/23/2020

    Bioavailability challenges are among the toughest problems faced by today’s formulators. Most of the prospective drugs in pharmaceutical pipelines today have low solubility, which means the active therapeutic ingredients can’t be absorbed when patients take them orally. This paper gives an overview of obstacles to bioavailability and summarizes the Lonza technology selection process.

84. Using Quality By Design For Process Development And Scale-Up Of A Novel ALS Drug Product 8/4/2020

    Thermo Fisher’s stepwise approach to Quality by Design (QbD), an approach that drives consistent quality into manufacturing, became integral to the success of Amylyx's AMX-0035 campaign. 

85. Minimizing Errors And Saving Time In Drug Receipt Processes 3/20/2019

    The speed-accuracy trade-off is a well-known phenomenon in psychology for processes requiring human input: the faster you go, the more likely it is that errors will be introduced into the system. 

86. Best Practices For A Successful Bioprocess Technology Transfer 9/10/2019

    A well-executed bioprocess technology transfer is critical to ensure smooth knowledge transfer and optimal process reproducibility. 

87. Optimizing Cell Culture Media: Increase Titer With Maintained Protein Quality 2/21/2020

    When evaluating media with the goal of increasing titers, it is important to ensure that protein quality is not negatively impacted. Here's how the process improvement can be performed reliably.

88. How Services Marketers Can Own Their Performance Measures 1/29/2019

    Service marketers can take control of their marketing performance by implementing credible marketing effectiveness measures and creating their own narrative.

89. An End-To-End, Semi-Continuous Process For mAb Production 9/22/2019

    See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.

90. Epitope Binning: A Critical Step In Antibody Selection 1/31/2020

    Epitope binning immunoassays using surface plasmon resonance (SPR) can and should be deployed in the development of new potential drug candidates. This article discusses how SPR is used to characterize closely related “bins” of mAbs targeting the same epitope of the target protein and how the selection process is used to develop new vaccines, therapeutic antibodies, and diagnostic tools.