Newsletter | November 14, 2019

11.14.19 -- cGMP Bioprocessing Regulatory Roadmap: Changes, Challenges, And Considerations

 
Developing A New Biologic Drug: Regulatory Challenges And Considerations
 

The journey from research lab to market is a long one, and most drug candidates do not make it. For those that do progress to market there are many regulatory milestones and hurdles. Following are some tips to assist with up-front planning to prevent headaches down the road.

6 Regulatory Changes Affecting Bioprocessing In China
 

Challenges with regulatory policies in China that make entry difficult and costly are causing outside pharma companies to hesitate to expand their global footprint into the country, despite strong government support for innovation. This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes
 

Through proper implementation of ICH Q12 tools and enablers, the industry could manage chemistry, manufacturing, and controls (CMC) changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective
 

Advanced therapy medicinal products (ATMPs) are medical products for human use, often used in regenerative medicine. There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

BioProcessing Asia Conference In Review
 

This e-book provides an illustration of the cutting-edge presentations from BioProcessing Asia 2018, from the sustainability of biosimilars to the regulatory climate in Asia, the challenges facing the international bioprocessing community, and the latest technologies for viral vector/vaccine production.


Fast Trak: Services from molecule to market

GE's Fast Trak services will help you to increase productivity, reduce costs, and bring your products to market faster. With a comprehensive portfolio of services including cGMP manufacturing, process development, and training, Fast Trak gives you the tools and know-how you need to solve biomanufacturing challenges and optimize your process.

 

Check out GE Fast Trak services around the globe.