Outsourced Pharma App Notes & Case Studies

  1. Paediatric Drug Product Development Through To Commercialization

    Almac has developed a flexible paediatric dosage form consisting of minitablets filled into stickpacks using a robust manufacturing and filling process suitable for routine commercial manufacture.

  2. A Flexible Antibody Purification Process Based On ReadyToProcess™ Products
    We have developed and used an efficient monoclonal antibody (MAb) purification protocol to reduce the level of aggregates from 10% to 0.4% in a two-step chromatography process giving a monomer yield of 81%.
  3. Mixing And Heating-Cooling Characterization Data For The Xcellerex XDM 50 Single-Use Mixer

    This application note describes mixing and heating-cooling characterization data for the Xcellerex XDM 50 single-use mixer. A design of experiments (DoE) approach to liquid-liquid mixing was successfully applied to establish a model to predict the mixing time throughout the working range.

  4. Propagation Of Influenza Virus In Vero Cells

    The aim of this work was to establish a process to produce influenza virus in Vero cell culture using single-use equipment. The end result would be a fast and simple process enabling scale-up and adaptation to industrial production. The following parameters were evaluated: medium composition, cell detachment, medium supplements, agitation conditions, and infection conditions. 

  5. Improved Bioavailability Of Trio Medicines TML-2 In 12 Weeks

    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. Trio turned to Catalent for help.

  6. Efficiency Test Of ReadyToProcess™ Columns

    ReadyToProcess™ columns are prepacked, prequalified, and presanitized process chromatography columns suited for purification of biopharmaceuticals (e.g., proteins, vaccines, plasmids, and viruses) for clinical phase I and II studies. ReadyToProcess columns are available with several media at different volumes (1, 2.5, 10, and 20 L).

  7. White Paper: Introduction To Cross Flow Filtration

    The purification of biological therapeutics generally utilizes both membrane and chromatographic separations. Membrane separations are complementary to chromatography and offer a number of key benefits: they are fast, robust, and can bring greater effectiveness to the key stages of bioprocessing, for example, by concentrating and washing feedstreams prior to chromatography

  8. The Use Of Dynamic Control In Periodic Counter-Current Chromatography

    The ÄKTA™ pcc 75 chromatography system can be used for purification of target proteins in continuous downstream processes using periodic counter-current chromatography (PCC). PCC enables greater utilization of the chromatography medium (resin) capacity, allowing sample loading to much higher levels compared with what is possible in traditional batch chromatography.

  9. Stick Packaging Delivers Portability, Convenience

    A contact packaging leader outfits its new facility with a new stick packaging line, giving pharmaceutical and nutraceutical companies another way to ease product use. By Ropack, Inc.

  10. Polishing Of Monoclonal Antibodies Using Capto™ S ImpAct

    Capto S ImpAct chromatography medium (resin) is a strong cation exchanger (CIEX). The medium is designed for the polishing steps of monoclonal antibodies (MAbs) and a wide range of other biomolecules.