Outsourced Pharma App Notes & Case Studies

41. Genome Editing of Human Primary T Cells With Lipid Nanoparticles 4/18/2022

    We show CRISPR/Cas9-mediated knockouts of the T cell receptor and explore multi-step LNP engineering to produce TCRɑβ KO CAR T cells, a promising approach towards allogeneic CAR T cell therapy.

42. Fundamentals Of Size Exclusion Chromatography 5/20/2021

    SEC, also known as gel filtration, can be used for preparative and analytical studies of your protein. But how do you know which parameters give you the best resolution of your protein mixture?

43. Method Transfer Of A USP Organic Impurities Method To An Arc HPLC 10/7/2022

    Learn about a global interlaboratory method transfer study of a USP impurities method that was conducted at eight participating sites.

44. 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.

45. Overcoming Biopharma's Top 6 Quality And Compliance Oversights 8/25/2021

    This article presents six common quality and compliance missteps that pharma companies either inadvertently enable or unknowingly perpetuate over time, with recommendations for mitigation.

46. Automating Document Control Processes To Comply With FDA And ISO Requirements 8/25/2021

    Your document control system should be agile and scalable to keep up with the changing regulatory landscape. Here, we detail the guidelines and standards that apply, and illustrate how digitizing document control processes is essential for ongoing compliance.

47. Biosimilars: Evolving Challenges And Considerations 1/11/2021

    Evolution of the biosimilar regulatory pathway will require manufacturers to ask critical questions about the implementation of legacy and novel technologies and procedures in downstream processing.

48. Improving Workflow Automation And Process Control 10/17/2022

    Learn about optimizing your T cell manufacturing process and reducing operating costs with rocking bioreactors using CTS OpTmizer T Cell Expansion SFM.

49. Intensified, Improved Fed-Batch Production Process 5/13/2021

    The method described here allows you to intensify your fed-batch process through reduced production duration without affecting the growth or titer profile.

50. Leveraging An Integrated Network To Accelerate Spray Drying And Tableting Scale-Up 3/4/2022

    A biopharmaceutical company sought to develop a commercially-viable tablet formulation for use in phase 2 studies, utilizing spray drying for solubility enhancement.