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Monoclonal Antibody Manufacturing for BioPharma: To Build or Outsource?

As the global biologics market continues to grow, securing speed with scale has never been a greater priority. Here we demonstrate important factors to consider in making optimal outsourcing decisions…

Setting The Right Goals: Go Digital, Not Paperless

Digital transformation initiatives can often times result in false starts and inefficiencies by overemphasizing “paperless” environments. Such endeavors focus on identifying and converting paper-based forms and procedures to electronic means,…

N-nitrosamines in Drug Products: Overview, Challenges and Lessons Learned from an API Manufacturer’s Perspective

By Karina Boszko, Head of API Regulatory Affairs and Customer Technical Support Department, Polpharma API Nitrosamines—how has it all started?In July 2018, the pharmaceutical industry was surprised by the unexpected…

Planning for Success, Addressing Quality Early for Gene Therapies

The approvals of Roche’s Luxturna® (2017) for inherited retinal disease and Novartis’ Zolgensma® (2019) for spinal muscular atrophy are indicative of a resurgence in the gene therapy field after a…

Exploring Ultra-Low Temperature Packaging Solutions for Gene Therapies

With the industry moving to more personalized medicine and delivering genetic material to patients to treat conditions resulting from genetic mutations, we speak to Sean Canavan, Operations Manager at Almac’s…

Managing Manufacturing in Times of Uncertainty

Virtual pharmaceutical companies often have strong regulatory and clinical teams, but lack the resources needed to address the complexities of the complete product development and commercialization cycle. Partnering with a…

Drug Manufacturing and Development in the Age of Precision Medicine

Growing demand for patient-centered healthcare presents fresh challenges for pharmaceutical product development and manufacturing. As precision medicine gains traction in research and development pipelines and the pharmaceutical marketplace, specialist providers…

Why Governments Need to Invest in Local Pharmaceutical Manufacturing, Research and Development

With much of the world now reliant on China and India for pharmaceuticals and the raw materials needed to make them, the risks of this reliance are now coming into…

Advanced ODT Technologies for Drug Development in Japan and the US

Since its introduction in the 1980s, the market for orally disintegrating tablets (ODTs) has grown annually, and ODTs are now available in a variety of therapeutic areas, both over-the-counter and…