Is Continuous Biomanufacturing a Good Fit for Your Process? – Continuous Biomanufacturing Implementation – Frequently Asked Questions
WuXi Biologics’ Hang Zhou, Ph.D, Director of Cell Culture Process Development addressed questions in a Q&A forum regarding the implementation of continuous manufacturing strategies for protein therapeutics. The session covered several common questions related to continuous biomanufacturing, including PAT initiatives, expected timelines, potential cost savings, optimization, process parameters, and lot release and how it compares with traditional fed-batch processes. (Read more)
Scale-Out Biomanufacturing – A Paradigm Change to Scale-Up – Summary of Webinar provided by Dr. Jie Chen, Vice President of CMC Management
In biomanufacturing, a production scale change is required to either meet the market growth demand or when a product moves from clinical to commercial manufacturing. How that volume is increased depends on whether a scale up or scale out philosophy is used. The industry standard has been to scale up, which translates to increasing the size of the bioreactors used in manufacturing runs. However, due to the recent availability and ease of single-use technologies, coupled with improvements in cell culture productivity; scale out may soon create a shift in the way biologics are manufactured. (Read more)
As China is the largest developing country with a dramatically aging population, the need for new medicines to treat cancer and other diseases is becoming urgent. Regulators, the pharmaceutical industry, and policy makers are working together to address both affordability and availability of these new medicines—especially mAbs. In this article the authors discussed the newly published CFDA guidelines on biosimilars and major regulatory reforms to drive innovation in China. Additionally the authors also reviewed the current landscape of biologics development in china. (Read more)
Overcoming Challenges in Developing Antibody Drugs Against Immune Check Point Targets – An Interview with Dr. Jing Li, Vice President of Biologics Discovery
In May, Dr. Jing Li, Vice President of WuXi Biologics, presented to approximately 175 attendees at the Cambridge Healthtech Institute’s (CHI) 11th Annual PEGS Essential Protein Engineering Summit at the Seaport World Trade Center in Boston, MA. This week we sat down with Jing to continue the discussion on the topic of overcoming challenges in developing antibody drugs against immune check point targets. (Read more)
Steve Kuehn of Pharma’s Almanac interviews Steve Farmer, Senior Director at WuXi Biologics about the real advantages of a streamlined single-source approach and how WuXi Biologic’s open access technology platform and extensive expertise delivers a right-first-time approach to support clients from early development to clinical trials.
Interview with Steve Farmer, Senior Director at WuXi Biologics, where he discusses with Bio-Rad, approaches to continuous manufacturing and the risks associated with scaling-up biologics manufacturing from clinical scale to commercial scale.
WuXi Biologics expands its biosafety testing capacities by adding a new facility in Suzhou, China. The 38,000 sq. ft. facility has been operational since December 2014 and provides viral clearance studies, cell line characterization and lot release testing services. (Read more)
Developing a Novel ADC for Global Market via Innovative Three-party Collaboration – An interview with Dr. Jiawen Han
Recently, Dr. Jiawen Han, Vice President of ADC Technology at WuXi Biologics, presented at the 1st DIA China Drug Discovery and Innovation Conference. This week we sat down with Dr. Han to provide a synopsis of his talk and discussion on the various challenges and approaches to developing novel ADCs for the global healthcare markets and to gain further insight on the case study he presented. (Read more)