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. WuXi Biologics Installs New Vial Filling System To Increase Production And Capacity

    Contract development and manufacturing organizations (CDMOs) test, produce and fill highly diverse pharmaceutical products for different customers. Sensitive liquid biopharmaceuticals are especially demanding in terms of filling processes. Hence, not every system is suited for every application. For several customers’ new products, the largest Chinese CDMO – WuXi AppTec – needed an additional filling solution and contacted Bosch Packaging Services to support with a modification of its existing Bosch FLC 3040 filling machine. For the first time, Bosch implemented a movable peristaltic pump filling system in China.

  3. Warehouse Monitoring: Medical/Surgical Supply Distributor Improves Efficiency And Compliance

    Owens & Minor, Mechanicsville, VA, is a leading U.S. supplier of medical and surgical products to hospitals, integrated healthcare systems, alternate care locations, and the federal government. The company serves the medical community from 50 plus distribution centers nationwide, providing consumable goods such as disposable gloves, dressings, endoscopic products, needles and syringes, sterile procedure trays, surgical products and gowns, and urological and wound-closure products.

  4. Biokit Futureproofs Diagnostics Business And Maximizes R&D Spend Through Introduction Of E-WorkBook

    Biokit, part of the Werfen Group, specializes in the research & development (R&D) and manufacturing of reagents for clinical diagnostics. Investing over 15% of its annual turnover into R&D, Biokit is committed to both innovation and quality through its customer-driven R&D approach, ensuring it can research, develop and manufacture in vitro diagnostic (IVD) devices in a sustainable way.

  5. Determining The Rheological Properties Of Pharmaceutical Products

    The rheological characterisation of microemulsions with the Rotational Rheometer RheolabQC gives essential information about their properties and the customer’s evaluation of the end product.

  6. 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.

  7. 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.

  8. Performing Quality Checks On Glycerine To Meet Pharmacopoeia Regulations

    Check the quality of glycerine throughout the purification process using Anton Paar digital density meters and refractometers.

  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.