Application Notes & Case Studies

  1. Flow and Gradient Accuracy Are Key To Scale Up And Speed To Market

    Accurate flow is important for your chromatography step to provide reproducible results at different scales. For ÄKTA pilot 600 chromatography system, flow and gradient formation is controlled by the UNICORN™ system control software. In this work, flow accuracy was investigated at a combination of different backpressures, flow rates, temperatures, and liquid viscosities.

  2. System And Production Hygiene Method Using Sodium Hydroxide

    The ÄKTA pilot 600 chromatography system is designed to facilitate sanitization, with the high standards imposed by regulatory authorities for purity of the clinical products in mind. In this study, the predefined sanitization method developed for ÄKTA pilot 600 was assessed.

  3. Managing Risks To Time Critical Product Imports At Clinical Supply Depots

    A Catalent customer wanted to run a clinical trial in Israel and was arranging to ship their clinical trial product from a non-Catalent facility in Europe to a Catalent-managed and audited depot in Israel. With the protocol based in the US and the investigational medicinal product (IMP) approved in the EU, the customer incorrectly assumed and, without checking further requirements, that Israel had the same QP (qualified person) approval process as the EU. This case study outlines the steps that Catalent took to ensure the QP release process could quickly advance in Israel while simultaneously updating the warning labels to meet the QP requirements.

  4. Innovative Clinical Supply Solutions - Cold Chain

    With our team of packaging experts and extensive cold chain capabilities, this case study discusses the creation a custom packaging and distribution solution to meet this client’s unique needs. Through our partnership, the product was successfully packaged in sufficient quantity and on time for the Phase I trial.

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

    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. Comparing Continuous And Batch Processing in Downstream Purification

    Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.

  7. Smarter Flowmeters For Filling Applications

    RONCHI MARIO developed its new filler around Endress+Hauser's new Dosimag and Dosimass flowmeters. The new filling machine generation of RONCHI MARIO S.p.A. features major innovations. Endress+Hauser's Dosimag and Dosimass flowmeters with integrated batching functionality are key components of the new machine concept.

  8. Calibration Management Increases Plant Availability

    Thanks to the set-up of a result-based calibration contract with Endress+Hauser and to the simplification of the operation, this major biotechnology plant has significantly reduced overall effort and calibration costs. The calibration time has also decreased, with positive impact on the plant process’s availability rate.

  9. External Management Improves Operational Quality And Increases Reference Meters’ Availability

    A biotechnology plant was struggling with the management of the calibration of the more than 100 reference standards covered about 20 calibration service providers. Endress+Hauser took the responsibility to manage the whole calibration process of the reference standards resulting in a reduction of non-conformities achieved has led to better operational quality.

  10. Bioprocess Plant Reduces Down Time With Self-Calibrating Temperature Sensor

    To keep the risks in bioproduction as low as possible, an increase in calibration frequency is required. Read how the self-calibrating iTHERM TrustSens temperature sensor kept Plant downtime and calibration times to a minimum.