Interview with David Radspinner, PhD, General Manager of Bioprocess Cell Culture at GE Healthcare’s Life Sciences business
In March 2016, David was appointed as the General Manager for the GE Healthcare Life Sciences newly created BioPark business. In addition, he will continue in his current role as General Manager, Life Sciences, for the Cell Culture business.
Previously, in January of 2014, GE acquired the HyClone Cell Culture business and subsequently David was appointed as its Hold Separate Manager.
David earned a PhD in Analytical Chemistry from the University of Arizona and has spent over 14 years working within the areas of developing, manufacturing and characterizing pharmaceuticals. David has over 10 years experience in business development, product management, sales, marketing and cross-functional leadership.
GE Healthcare's Life Sciences business is now producing high quality powdered media at its new Cell Culture Media facility. Located at Tuas, Singapore, the facility aims to supply cell culture media to meet the growing demand from the local region and worldwide.
The following interview with GE Healthcare’s Life Sciences business was conducted to better understand the roles played by GE’s Cell Culture Media facility in Singapore.
1. When did GE’s Cell Culture Media Facility in Singapore start to operate? How long have you been producing cell culture media?
We began production of our powdered media for commercial supply at the Singapore facility in December 2014. Since then, we have supplied our media to customers in the Asia region. Several customers have now validated the quality of our media and the equivalence with products manufactured in our Logan, Utah, U.S. facility.
The facility also serves an important role as an additional source of media to other parts of the world in the event of incidents that might halt supply from other manufacturing sites.
2. How many staff do you have in GE’s Cell Culture Media Facility in Singapore? Who is handling (and leading) the in-house media production?
The site currently has 18 employees, and we are actively recruiting for more. Current positions are posted on the GE ASEAN Careers Page on LinkedIn: https://www.linkedin.com/groups/4633394/profile.
We have a highly qualified team of cell culture media experts to oversee the production of the cell culture media at the Singapore facility. The leadership team has decades of experience working in a cGMP environment.
3. The facility mirrors the site in Logan, U.S. Why has GE set up a cell culture media facility in Singapore despite having climate/weather concerns?
There is a shift in the geographical demand for in-market biologics and a promising new generation of drugs. A thriving middle-income population, and a rising tide of ageing-related and lifestyle diseases, are driving an increased demand for biosimilars, insulin and vaccines across Asia. Cell culture media is a crucial component used in the discovery and manufacture of medicines to treat these kinds of diseases. Examples of products manufactured with cell cultures include medicines against cancer and rheumatoid arthritis, as well as a new generation of vaccines.
The Singapore facility is an integral part of our global manufacturing capacity. It increases our global cell culture media production capacity, complementing our existing facilities in Europe and North America, and provides a local supply source for the Asian market. The Singapore site enables us to offer our local customers faster delivery of products and gives us redundant global capacity for enhanced security of supply for all our customers.
4. What are the critical considerations in order to produce high quality powdered media?
The cell culture media supplied from this facility is used in many different parts of the drug development lifecycle; from life science research to the production of biopharmaceuticals and vaccines. Hence, product quality, traceability and performance are critical. We monitor site metrics in real-time, with a daily schedule of meetings to review performance, and efficiently escalate and resolve any potential issues. All our production technicians are extensively trained to ensure full competency in the handling of the manufacturing equipment, as well as compliance to cGMP.
5. What steps do you take to overcome the challenges in maintaining quality of the products manufactured in Singapore?
In order for us to produce media for commercial supply, our engineers and technical experts initially needed to overcome some challenges of operating in the Singapore environment. The biggest hurdle was the constant high humidity compared to our U.S. operation in Logan, Utah. Since December 2014, we have supplied powdered media from Singapore and we now have results from customer audits consistent with our site qualification and validation tests to verify the high quality of our media.
6. Besides U.S. and Singapore, does GE have other media production facilities in Asia Pacific region?
Currently this is our only cell culture media production facility in Asia Pacific.
7. What is the demand for the media in Singapore or in the Southeast Asia region (or who are you supplying the media) after the production?
The global cell culture media market was valued at $2B in 2015 with a 5% Compound Annual Growth Rate (CAGR) predicted between year 2014-2019. According to a report published by BCC Research in 2015, the Asia media market is predicted to grow at 10% over the same period, reaching $394M in 2019. For powdered media in Asia alone, the market is estimated to grow to $220m by 2019, representing a 10.7% CAGR.
As our commercial relationships are confidential, we are unable to disclose the names of any of our customers.
8. What other services does your facility render than producing cell culture media?
Currently the facility is set up only to produce powdered cell culture media in order to meet the biggest demand of the anticipated market growth. However, we are closely monitoring the market and the needs of our customers to understand if additional capabilities could better support local biomanufacturing in the Asia region.
All images are provided by GE Healthcare