Industry Insights

51. Building AAV Manufacturing Capacity For Large Patient Diseases 11/15/2023

    AAV-based gene therapies are poised to treat larger patient populations with diseases like cardiovascular and neurological conditions. But scaling poses safety and manufacturing challenges. This deep dive into the issues could help companies clear away some of those obstacles. 

52. Cell & Gene Therapy Financing: What Is The Role For Private Equity And SPACS? 8/26/2021

    This article explains how SPACs help cell and gene companies go public with some advantages.

53. The 'Champagne' Of Human Umbilical Cord Cells? 2/23/2023

    Learn about a novel method to obtain unique HUCPVs and how premium quality hUC-MSCs drive innovative translational research.

54. Mitigating Risk In IND And Drug Product Development 1/22/2026

    Early CMC planning, a focus on manufacturability, and timely data generation help drug candidates cross the Valley of Death by reducing regulatory risk and easing clinical transition.

55. Nitrosamine Impurities In Medicines: What Have We Learned? 7/8/2020

    This article discusses the new EMA report "Lessons Learnt from Presence of N-nitrosamine Impurities in Sartan Medicines," sharing recommendations and the path forward suggested by the European regulators, as well as lessons learned from the GMP sampling, testing, and inspection processes.

56. Quintessential Role Of Apheresis In Gene-Modified T-Cell Therapy 6/20/2023

    Learn more about process standardization and comprehensive quality management programs as it relates to leukapheresis and cell therapy manufacturers.

57. Comment On Biopharmaceutical Classification System And Formulation Development 10/26/2012

    This is the first installment in a series of articles that will provide an overview of an area of potential interest to the readers of Pharmaceutical Online and Outsourced Pharma. By Mark Mitchnick, MD, and Robert W. Lee, PhD

58. AI's Potential To Aid Multispecific Analytical Characterization 5/16/2025

    Orthogonal analytical techniques are essential to characterize CQAs, support regulatory submissions, and validate AI-predicted formulation strategies.

     

59. Establishing A Resilient cGMP Chemical Supply Chain 4/6/2022

    The entirety of your supply chain should be considered before building resilience into your workflow. Review the most important considerations to make.

60. ITC For Binding Characterization In Pharmaceutical Research 4/24/2025

    Discover an Isothermal Titration Calorimetry tool that is precise for characterizing molecular interactions, which is crucial for drug discovery and lead optimization in pharmaceutical research.