Outsourced Pharma App Notes & Case Studies

61. Scaling The Advanced Therapy Supply Chain 2/13/2019

    This case study describes the use of dispersed storage and cold chain logistics, around a central manufacturing facility to create a cost efficient and robust supply chain.

62. Modular Bioprocessing Alleviates Drug Manufacturing Woes 4/4/2019

    Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in various industries.

63. Automated High Throughput mAb Purification Using Fibro Technology 4/21/2020

    Biomanufacturing is trending towards higher numbers of monoclonal antibody (mAb) projects and smaller batch sizes, with production of most mAbs below 100 kg/yr. These trends are fueling demands to screen more clones faster and improve the efficiency of process development (PD). Read how the Fibro PrismA unit provides a time advantage with comparable recovery and product quality attributes to resin-based column.

64. A GMP Strategy For ADC Synthesis Using Site-Specific Chemical Conjugation 3/10/2020

    Learn about the establishment and application of a GMP strategy for site-specific ADCs production using AJICAP technology, a chemical conjugation platform that employs IgG Fc-affinity peptides.

65. Multidimensional Scale-Up Of A mAb Capture Step Contributes To Shortened Time To Market 10/10/2018

    This application note demonstrates a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system.

66. Use Of Sodium Hydroxide For Cleaning And Sanitization Of Chromatography Resins And Systems 10/2/2018

    This application note examines these aspects of using sodium hydroxide as a cleaning and sanitizing agent.

67. Validating The Stability And Durability Of Labels After Thawing From Cryogenic Temperatures 2/26/2019

    One important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.

68. Technology Selection To Enhance Bioavailability 7/23/2020

    Bioavailability challenges are among the toughest problems faced by today’s formulators. Most of the prospective drugs in pharmaceutical pipelines today have low solubility, which means the active therapeutic ingredients can’t be absorbed when patients take them orally. This paper gives an overview of obstacles to bioavailability and summarizes the Lonza technology selection process.

69. Manage Risks In Development And Manufacture Of Potent Pharma Products 6/17/2019

    Given the variety of potent drugs in development, outsourcing the development and manufacturing to a CDMO experienced in handling a range of products, in a multi-use facility, is an effective strategy.

70. Best Practices For A Successful Bioprocess Technology Transfer 9/10/2019

    A well-executed bioprocess technology transfer is critical to ensure smooth knowledge transfer and optimal process reproducibility.