INSIGHTS ON DRUG DEVELOPMENT

• 6 Regulatory Changes Affecting Bioprocessing In China

  This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

• Key Considerations For A Successful EU Orphan Drug Launch

  During this interactive webinar, the speakers involved will utilize their experience to guide you through the EU product launch process, from submitting your Marketing Application (MA) to final distribution of drug product to the end-user.

• A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand

  An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.

• Integrated Tools For Upstream Process Intensification: Part II

  Changes to bioprocessing methodologies in the biopharmaceutical industry are being driven by the need for increased speed, a lower cost of goods (COGs) and greater flexibility. Faster development times are required to progress biologics and vaccines more rapidly into clinical development and then to market to improve worldwide accessibility. Continue reading in part 2 of this series how in order for intensified and continuous bioprocessing to deliver on these quality and productivity promises, there is a requirement for intelligently designed products.

• Critical Considerations About The Future Of Global Cell Culture Bioprocessing

  In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.

• Build Efficiency Through Continuous Characterization

  Bioprocessing development is a long and costly process. Building in continuous characterization and connected bioprocessing cuts timelines and increases the available information through real-time analytics.

• Viral Clearance: 7 Chromatography Column Considerations

  Viral clearance studies are a critical part of the production of biologics. Here are seven things to consider while performing your next chromatography viral clearance study.

• Optimize Manufacturing Using Comprehensive Powder Characterization

  Understanding the range of powder behavior characteristics through measurement of the most appropriate properties is essential for efficient processing and consistently high-quality finished products.

• Optimizing Process Efficiency In Upstream Manufacturing

  Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.