Outsourced Pharma App Notes & Case Studies

  1. Improve Throughput And Cost With Continuous Downstream mAb Processing

    In this study, periodic counter current chromatography and straight-through processing technologies were evaluated in a continuous three-step monoclonal antibody purification process.

  2. Ready-To-Use Fluid Management Solutions For Cross Flow Filtration Systems

    A selection of fluid management components from GE Healthcare’s ReadyToProcess platform of disposable and single-use equipment was used to arrange buffer and sample management solutions for two large-scale filtration setups.

  3. Capsule Dosing Techniques For Dry Powder Inhalers

    Dry powder inhaler (DPI) devices that utilize two-piece capsules as the dose-holding system can require specialized dosing equipment to fill the capsules. Such products are known as "premetered."

  4. Achieve Continuous Supply Of Drug Treatment For Study Requirements

    A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.

  5. Two-Step Purification Of Monoclonal IgG1 From CHO Cell Culture Supernatant

    The increasing demand for monoclonal antibodies (MAb) as biopharmaceuticals has promoted the development of cell cultures with increased expression levels. As a consequence, the demand for more effi cient purifi cation processes has increased. This application note describes a two-step process for MAb purifi cation based on MabSelect SuRe™ and Capto™ adhere, a strong multimodal anion exchanger. By GE Healthcare

  6. Application Note: Automated Cross Flow Filtration For Process Development, Filter Screening, And Process Optimization At Small Scales

    This application note focuses on microfiltration (pore sizes between 0.1 µm and 1 µm). Microfiltration is ideally suited for separation of cultured cells from the growth medium (broth), as well as for sterilization, and contaminant and particle removal in numerous biopharmaceutical processes

  7. A Single-Use, Stirred-tank Bioreactor System For Various Cell Culture Applications

    This application note describes the physical characteristics of the XDR-10 bioreactor system suitable for use in mammalian cell culture applications. The presented data can be useful in process transfer and comparison of different bioreactor systems.

  8. Are You Into Biosimilars?

    Biosimilars are considered to be one of the fastest growing sectors of the pharmaceutical industry.

  9. An Innovative Solution To Flexibly Meet Unique Primary Packaging Requirements

    A customer enlisted Catalent to support their child-resistant blister packaging requirements for a global Phase III study. A flexible design was created with an integrated blister card that could also support larger study requirements of 1.9 million monthly dosing cards. Through customized commercial blistering equipment a solution was provided that would accommodate the customer’s growing demands for clinical supplies.

  10. E. coli Growth Dab Expression In Single-Use And Stainless Steel Fermentors

    This application note describes the performance of the Xcellerex™ single-use XDR-50 MO stirred-tank fermentor in an E. coli domain antibody (Dab) production process developed for a stainless steel fermentor. Cell growth, cell density, and Dab expression levels were assessed and compared between the two production vessels. The results show that the performance of the XDR-50 MO fermentor is comparable with that of the reference stainless steel fermentor.