Outsourced Pharma App Notes & Case Studies

  1. Quantitating Binding Similarities In IgG Fcγ Receptor Analysis 5/23/2019

    Critical quality attributes are fundamental to regulatory compliance in drug development and manufacturing. Learn how surface plasmon resonance has been applied for protein characterization of antibody effector function.

  2. How Biopharma Is Capitalizing On The Antibody Boom 10/10/2018

    Antibodies continue to dominate. Analyzing the strategies employed by successful players in the field could provide invaluable lessons for those hoping to enter it.

  3. Scaling The Advanced Therapy Supply Chain 2/13/2019

    Treating castration resistant prostate cancer means that failure within the advanced therapy supply chain has a catastrophic impact on patients. This case study describes the use of dispersed storage and cold chain logistics, around a central manufacturing facility to create a cost efficient and robust supply chain.

  4. Accelerated Manufacturing Of Subunit Vaccines For A Rapid Pandemic Response 8/3/2018

    This application note describes a process for rapid production of recombinant anthrax protective antigen (rPA) in short process time for the manufacture of an anthrax subunit vaccine.

  5. A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations 6/10/2019

    Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.

  6. Standardizing Process Characterization And Late Phase Development 11/18/2019

    Process characterization is an important step in the overall journey of product development. This case study proposes an approach for process characterization for the production of a monoclonal antibody, specifically at the drug substance biomanufacturing step.

  7. 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.

  8. Process Economy Of Using Cytodex Gamma Microcarriers 8/3/2018

    Microcarriers are commonly used in bioreactor cultures to provide a large growth surface for anchorage-dependent cells, and are typically provided either untreated or gamma-irradiated and ready for use.

  9. Doubling Up For Speed: Using Parallel Operations In Biopharma Manufacturing 6/21/2018

    One solution to drug development challenges is adopting a parallel operations business model. This article offers recommendations for how parallel operations can be leveraged in a biomanufacturing strategy.

  10. 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.