Outsourced Pharma App Notes & Case Studies

51. Regulatory Challenges For Viral Vectors For Cell And Gene Therapy 7/24/2020

    Frost & Sullivan's Virtual Think Tank series brought together leading minds in the cell & gene space to discuss current regulatory issues and key challenges in viral vector manufacturing.

52. Purifying Infectious Virus Particles Using ÄKTA™ Start 5/20/2021

    This application note demonstrates a chromatography method for purifying reovirus RNA virus particles using a benchtop chromatography system, HiTrap brand columns, and Capto brand Core 700 resin.

53. What Big CROs Don’t Want You To Know About Staffing Scalability For Phase III Studies 10/1/2021

    Don’t settle for recycled employees poached from other studies when therapeutically-aligned, passionate, and accountable personnel — eager to work on your specific study — are available.

54. Finding Impurities And Controlling Formations At Release 10/27/2020

    An imperative factor during the manufacturing process is to keep the introduction or generation of impurities to a minimum. Discover how LC/MS within a systematic approach can be used to reveal the sources of impurities.

55. Advanced Formulation Development By Design: Holistic Drug Production 4/15/2021

    Drug substance/drug product biomanufacturing complexity is increasing. Solving challenges calls for innovative mindsets, advanced technology, and proficient and complementary expertise.

56. Solving Capacity Shortages In The Cell And Gene Therapy Space 12/23/2021

    Creating new manufacturing capacity requires finding the right CDMO with a global footprint, large-scale capacities and resources, and technical expertise in developing and bringing treatments to market.

57. Outsourcing Process Dev: Key Considerations For Biopharma 3/14/2022

    In Best Practices for Outsourcing Process Development, a panel of experts discussed four themes that may help drive the best outcomes when vetting process development service providers.

58. A Compliant-Ready Workflow For Peptide-Based Multiple Attribute Method 2/22/2022

    Here, we demonstrate an end-to-end analytical workflow developed for the peptide-based multiple attribute method (MAM). This platform provides a compliant-ready environment for automated data acquisition, processing, and reporting of product quality attributes (PQAs) for a monoclonal antibody (mAb) standard.

59. Crystallization Process Dev: Ramping Up Bench-Scale Control 1/20/2022

    Since physical structure and biological activity are directly linked, controlling the physical form of a compound is paramount to a final drug product’s quality and effectiveness.

60. The Changing Dynamics Of The Pharma/Biotech Supply Chain – A Packaging And Clinical Supply Perspective 3/29/2021

    Perhaps more than any other industry, pharma and biotech have undergone radical change over the past year, as a result of the COVID-19 pandemic. From supply chain security and capacity to clinical trial operations and site auditing, almost every aspect has been affected. Experts explore how these trends are shaping the industry and offer an outlook.