Bioprocessing Application Notes & Case Studies

  1. Optimizing Small Batch Size To Solve Formulation Challenges
    4/25/2017

    If current manufacturing practices are followed to handle small batches of API on industrial size machines, it results in handling difficulties and lower product yield.

  2. High-Density 50 L Perfusion Cell Culture Using A Single-Use System
    4/18/2017

    This study shows the integration of the Thermo Scientific HyPerforma Single-Use Bioreactor and the Repligen XCell ATF 6 Single-Use System to achieve a stable, high-density perfusion cell culture, at 40 x 106 cells/mL over 20 days, without modifying the standard systems.

  3. Efficient Operations Of The HyPerforma 5:1 Single-Use Bioreactor At Low Working Volume Application Note
    4/18/2017

    The Single-Use Bioreactor with a 5 to 1 turndown ratio was developed in response to end-user interest in operating Single-Use Bioreacors at lower working volumes in order to realize improved seed-train utilization and better mixing throughout drainage.

  4. Microcarrier Bead Separation And Cell Harvesting Using The Harvestainer Small-Scale System Application Note
    4/18/2017

    Current techniques used to separate adherent mammalian cells from microcarrier beads include: sedimentation using conical or inclined settlers, centrifugation, acoustic resonance, spin filtration, and microfiltration.

  5. Microcarrier Bead Separation And Cell Harvesting Using The Harvestainer Large-Scale System Application Note
    4/18/2017

    Current techniques used to separate adherent mammalian cells from microcarrier beads include: sedimentation using conical or inclined settlers, centrifugation, acoustic resonance, spin filtration, and microfiltration.

  6. Scalability Of Microcarrier Bead Separation Using The Harvestainer Systems Application Note
    4/18/2017

    Current techniques used to separate adherent mammalian cells from microcarrier beads include: sedimentation using conical or inclined settlers, centrifugation, acoustic resonance, spin filtration, and microfiltration.

  7. Optimizing Single-Use Bioreactor For Adherent Cell Culture On Microcarriers Application Note
    4/18/2017

    The scale-up of culture of adherent cells, such as Vero cells and fibroblasts, can be difficult. This study shows a process for scaling up Vero cell culture from static T-flasks and Thermo Scientific™ Nunc™ Cell Factory™ Systems to a stirred-tank system, utilizing Thermo Scientific™ HyPerforma™ Single-Use Bioreactors (S.U.B.s) and Cytodex™ 3 microcarriers (GE Healthcare).

  8. Avoid Packaging Errors, Headaches And Recall Costs On Multi-language Products
    4/13/2017

    Trust is arguably the lifeblood of the heavily regulated industry in which Russian biotechnology company GENERIUM operates. It’s paramount to success, both on the part of customers and in the quality-control software that serves as the last line of defense before products hit the market. It’s no small coincidence that GlobalVision has become that platform for GENERIUM.

  9. OptiForm® Solution Suite: Improved Bioavailability Of Trio Medicines TML-2 In 12 weeks
    4/11/2017

    Trio Medicines Ltd (Trio) is a London-based pharmaceutical company, founded in 2005. Trio is developing treatments for unmet medical needs, including rare diseases, with the aim of improving the health and quality of life of patients worldwide. Trio’s lead compound TML-2 is the acetyl prodrug of TML-1, a novel, well tolerated G-protein coupled receptor antagonist which shows clinical promise but has limited bioavailability owing to low solubility. The prodrug approach was only partially successful in increasing the solubility and bioavailability of TML-1, so Trio turned to Catalent for help. Utilizing OptiForm Solution Suite platform, Catalent’s experts screened 3 formulation technologies, and provided 4 formulation prototypes, in only 12 weeks. In 3 of the 4 prototypes, bioavailability of TML-2 was enhanced substantially.

  10. A DoE Approach To Liquid-Liquid Mixing
    4/10/2017

    This application note describes mixing and heating-cooling characterization data for the Xcellerex XDM/ XDUO 500 single-use mixer. A design of experiments (DoE) approach to liquid-liquid mixing was successfully applied to establish a statistical model to predict the mixing time throughout the working range.