Bioprocessing Application Notes & Case Studies

  1. Automation, Modularity Allow mAb Biotech To Cut Scale-Up Time

    Biomanufacturers, especially those facing the debut of biosimilars in core markets, have an urgent imperative to reduce manufacturing costs via increased productivity and yields. In turn, this drives a wide range of business decisions, including capital investment, process choices and design, and equipment selection. Learn how AlphaMab Co. Ltd, a fast-growing bio-developer and producer, cut scale-up time using a Quality by Design (QbD) approach.

  2. Simple Transfer Of An Itaconate Production Process

    The unsaturated dicarboxylic acid itaconate is used as a building block for the production of pharmaceuticals and adhesives, as a copolymer for synthetic resins, and is a promising starting material for biofuel production.

  3. Automatic Fermentation For Microbial And Mammalian Cultures

    The Auto Culture modes, standard on the BioFlo 120 bioprocess control station, offer push-button automatic process control for some of the most common microbial and mammalian (Chinese Hamster Ovary) cultures.

  4. Mixing Characterization For Buffer And Media Preparation: Mobius® Power MIX 2000

    Mixing of buffers (sinking powders) and media (floating powders), especially at high volume, presents substantial challenges in getting good dispersion and dissolution of particles. The creation of a vortex and abundant surface movement in the Mobius® Power MIX 2000 is key to the success in these processes. The axial and radial flow patterns allow for quick distribution of sinking powders, minimizing settling at the bottom of the vessel.

  5. Mixing Characterization For Buffer And Media Preparation

    This application note presents performance data from the Mobius® Power MIX 2000 for mixing of several sinking and floating powders. A characterization map of liquid-liquid mixing for a range of volumes and speeds is also included.

  6. A Strategy For Cost-Effective Capture Using Agarose-Based Protein A Resins

    Today, the majority of therapeutic antibodies are purified with agarose-based Protein A resins, and currently only one vendor on the market has the capacity to supply agarose-based resins in volumes required by the industry. But with the introduction of Purolite’s new Protein A resins — in combination with building a full-scale state-of- the-art manufacturing plant with the capacity to produce 100,000 L of agarose resin per year — this will soon change.

  7. Implementing Next-Generation Laboratory Informatics

    Electronic Lab Notebooks are a key component of an electronic lab environment that helps scientists execute faster, more informed, high-quality science. It’s a vision scientists have talked about for decades.

  8. How AstraZeneca Improved Validated Workflows In GMP API Manufacturing

    The reality is that paper is more of a habit than a requirement. AstraZeneca discovered this when they aimed to introduce ELNs to improve the efficiency of their validated workflows for GMP API (active pharmaceutical ingredient) manufacture. Paper and its associated workflows were standard only because they were familiar and had been defined over time to meet the needs of scientists, process engineers and quality control and assurance staffs.

  9. True Scientific Knowledge Management In R&D: Electronic Laboratory Notebooks (ELNs)

    One tool holds a unique position among R&D informatics systems. Unlike other systems, electronic laboratory notebooks (ELNs) both produce data and consume information. An ELN’s ability to capture data, observations, experiences, and context is particularly powerful when combined with other data pipelining tools. The ability to link key pieces of data and mine experiments captured in the ELN for insights fuels true scientific knowledge management. This use case describes the broad organizational benefits that BIOVIA Workbook made possible for a global pharmaceutical company, highlighting how the system is supporting efforts to gain predictive control over key processes in Research and Development.

  10. Biogen And Biovia: Answering Pharma Manufacturing’s Call

    Biogen’s Cambridge Manufacturing Facility leaders assessed their paper-based SOP delivery system. Their findings were that their procedures were inefficient and costly.