Critical Considerations About The Future Of Global Cell Culture Bioprocessing

With the rising number of patients and the growing presence of noncommunicable diseases creating a need for both existing treatment options and advanced strategies, it is critical to consider the impact of cell culture bioprocessing on the future of patient treatment.

6 Regulatory Changes Affecting Bioprocessing In China

Recent reports about the Chinese pharmaceutical industry estimate its worth at $122.5 billion, making it the world’s second-largest national pharmaceutical market, with growth anticipated to reach up to $175 billion by 2022. This article outlines six regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

A Common Sense Approach To Sustainability In The Biosimilar Business

Biosimilars can be an important market opportunity, reaching new global customers in emerging markets that are increasing spend on healthcare fueled by the rise of the middle classes. Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in biosimilars.

The Use Of Cell-Free Synthesis In The Future Of Modern Medicine

Cell-free synthesis systems are well suited to manufacture at the point of treatment, improving patient access, particularly to communities without established distribution networks. Yet, transitioning to a more efficient model for the future of medicine faces several challenges due to restrictions in today’s regulatory, development, and manufacturing environments.

Developing A Scalable Process For Adenovirus Manufacturing

As a growing number of approvals inspire more companies to explore and invest in viral vector manufacturing, increasing speed and efficiency in the current methods is critical. Learn how a new process for adenovirus manufacturing not only meets regulatory requirements but is also scalable.

ICH Q12 Updates: Increasing Predictability And Efficiency Of Post-Approval Changes

Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharmaceutical quality system with less need for extensive regulatory oversight prior to implementation.