Industry Insights

41. 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. 

42. How 'Explainable ML' Can Improve Process Performance 1/23/2025

    In a case study, chromatography process data converted into "images" equipped artificial intelligence to help manage dynamic binding capacity degradation.

43. ICH Guidelines: Challenges And Solutions For Pharma Manufacturers 10/8/2024

    Take the next step in enhancing your pharmaceutical manufacturing processes by investing in a robust quality management system (QMS) designed for ICH compliance and operational excellence.

44. Transitioning From A Vial To PFS Or Cartridge In An Auto-Injector Device 12/2/2022

    Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.

45. In Silico Approaches Towards Automated Biomanufacturing 11/6/2023

    As part of MSAT, in silico approaches such as mechanistic modeling can be used to support and facilitate several activities in the production of biopharmaceuticals at all scales.

46. Tackling Pharmacovigilance Issues In The Clinical Trial Stage Of Product Development 9/24/2019

    Pharmaceutical and device manufacturing companies often outsource their pharmacovigilance (PV) activities to vendors and consultants to meet their safety, medical information, and regulatory needs. When doing so, these companies have a regulatory obligation to oversee the activities and quality of their vendors. However, vendor audits conducted by these companies can yield a wide range of results due to differences in auditors, scope, and understanding of PV principles and operations.

47. New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings 1/15/2025

    To understand biotech companies’ evolving geographic strategies and perceptions, Arriello recently commissioned a transatlantic survey among regulatory, safety, and quality directors at small/medium biotechs, with respondents in Ireland and North America.

48. Keys To Achieving Unparalleled Flexibility In CHO Based Bioproduction 8/16/2025

    The dynamic growth and pace of change observed in novel mAb formats and cell and gene therapies emphasizes that biomanufacturing innovation is essential to deliver scale, speed, and sustainability.

49. 3 Key Bottlenecks In Cell Therapy Supply Chains 6/10/2025

    Ensure your cell therapy program is prepared for the future by learning how to effectively navigate sourcing, logistics, and manufacturing challenges with confidence.

50. A New Paradigm In T-Cell Lymphoma Treatment: CD5 CAR-NK 4/14/2025

    T-cell lymphomas are a complex and increasingly prevalent group of cancers with poor survival outcomes and limited effective treatments, underscoring an urgent need for innovative therapies and novel targets.