Cell Therapy Industry: What’s in it for Singapore?
This article is reproduced courtesy of Biotechin.Asia.
Biotech Connection Singapore organized a panel discussion and Networking Reception on Feb 12th. The topic of discussion was‘Cell therapy Industry: What’s in it for Singapore?’
Biotech Connection Singapore is a non-profit organization which is part of an international network consisting of 8 chapters in different countries that aims to promote the transfer of ideas from theory to real world applications by providing a platform for fostering interaction between academia, industry and businesses. It is a fast growing organization, and currently the Singapore chapter has over 800 members.
The invited speakers were Prof James Hui, Head & Senior Consultant, Division of Paediatric Orthopaedics and Director, Cartilage Repair Program, National University Health System, Mr Kim David Raineri, Business Director, Lonza Bioscience Singapore and Dr Steve Oh, Senior Principal Scientist, Bioprocessing Technology Institute, A*STAR, Singapore and Vice President, International Society of Cell Therapy (ISCT) Asia.
The moderator, Dr. Christine Cheung, IMCB Junior Investigator, A*STAR, Singapore and Event Lead, Biotech Connection Singapore put forward few questions and thoughts on Cell Therapy and the three speakers were extremely happy to answer and engage the audience. Various topics including stem cell therapy, scalability, industry regulations, potency assays for stem cells and bioprocess technology for stem cells were discussed in the 100 minutes of Panel discussion.
The topics discussed were:
- Are our technologies ready to develop the ideal candidate for cell-based therapy possessing characteristics such as accessibility, ease of scaling up, long term safety profile and autologous in nature, etc?
- Japan, Korea and China have emerged as the strong contenders in the development of cell therapy. Is our regulatory framework sufficiently established to administer cell therapy trials locally?
- How do we prevent non-compliant clinical practices which put desperate patients at risks?
- Patient-to-patient variability in stem cell therapy
- Autologous vs. Allogenic cell therapy
The session was extremely interactive with numerous questions from the audience and a networking session followed the panel discussion. The event was sponsored by StemCell Technologies.
Few bytes from the Panel Discussion are as follows:
Dr Steve Oh said, “It has taken us 5 years for the transition from petridish-grown stem cells to manufacturing them in a large scale in bioreactors. We are trying to grow adult mesenchymal stem cells (MSCs) in 3D format and were quite successful at the neural progenitor level. We are moving towards bone and cartilage regeneration now.”
“Nowadays, most researchers and industries are looking into serum-free media for growing stem cells since all the animals in the world will not be enough to obtain serum for growing cells in bioreactors. Chemically-defined media is the way to go and we have been working with a lot of companies to derive such media.”
When asked about regulations on cell therapy, Dr. Steve said that regulators are definitely bothered about safety and side effects. There is definitely a need to lay down rules for patient-specific treatment. He also added that the immediate need was to develop potency assays for cells. The doubling time of cells is a huge worry and it needs to be checked periodically for each cell line grown in bioreactors over time. The advantage of using fetal MSCs is their growth rate, life span and also because they generally do not cause tumors. However, the switch of the cells’ cytokines profiles is unknown and we do not know if it good or bad for the cells as such. He said that dental pulp stem cells are the new ‘hot topic’ now in the field of stem cells.
“Cell therapy is the most cutting edge technology discovered by scientists. However the first hurdle is that in stem cell culture, cells are adherent and hence scaling up is difficult, thus it is important that the 3D format of cell culture needs to be accelerated”, Mr. KimRaineri from Lonza said.
He also added that all the regulations regarding stem cell therapy is all in place, however there is a grey area that needs to be explored. He explained that early characterization of stem cells to check their efficacy is the need of the hour. Generally for every 3 donors only 1 is a ‘good one’. There are still a lot of unknowns in cell therapy and he stressed the need for the scientific community to step up and elucidate the paracrine factors responsible for the cells to grow. According to him, that would be the next step and the key question in the evolution of cell therapy ; to identify what are the cells doing, what therapeutic effect they provide.
When asked on cell therapy industry in Singapore, he said that Singapore cannot become the clinical trial hub since the population is less. It is and will be the manufacturing and scientific hub for stem cells. But he felt that scientists, clinicians, doctors and industries in Singapore have to push themselves more to get a footprint in Cell therapy.
Prof James Hui has been performing cell therapy on patients for the past 15 years since the first health service grant was awarded by MOH to NUH. His success rate had been good; an example he gave was of a patient who has been undergoing cell therapy instead of total knee replacement for 15 years now. He gave a very interesting perspective to the whole issue as he was well-versed with the clinical treatments available. He said, “Cell therapy is a magic bullet, it just needs to reach its destination safely. But there is no way of knowing where the injected stem cells go in the human body. Local regulations in Singapore take cues from FDA in case of cell therapy. However, this does not apply to therapy conducted in Japan and small private clinics in the USA. It is a cultural thing, as in Japan, patients revere doctors as semi-Gods and implicitly trust their decisions when it comes to experimental therapy. Hence it is not that easy to apply stem cell treatment in Singapore.”
It is interesting to note that around the same time there was news of a doctor in Japan who carried out a cartilage regeneration procedure successfully using stem cells. The Japanese doctor and his team from Hiroshima University Hospital injected stem cells laced with iron powder into the knee joint of an 18-year-old girl. Then they used a magnet to concentrate the stem cells in the affected area and this they hope will help repair the damaged cartilage.”
Dr. James Hui and his team have been performing autologous stem cell therapy and he says they are the safest and have a highest percentage of success. He stressed that people need to understand that Cell therapy is not drug therapy.
Due to the recent surge in the field of regenerative medicine using patient’s own cells for therapeutics, the panel discussion organized by Biotech connection Singapore was very informative and the discussion gave a clear perspective about the opportunities and challenges of translating stem cell research into clinical applications in the present times.
Prof. James Hui
Head & Senior Consultant, Division of Paediatric Orthopaedics
Director, Cartilage Repair Program
National University Health System, Singapore
Prof. James Hui specializes in the management of orthopaedic problems in children, as well as general orthopaedics. His special areas of interest are the care, rehabilitation and surgical treatment of musculoskeletal problems occurring in infants and children, such as hip dysplasia and dislocation, foot deformities, spinal deformities, limb length discrepancies and neuromuscular disorders such as Cerebral Palsy, Spina Bifida and Muscular Dystrophy.
Prof. Hui completed his medical degree at the National University of Singapore. He subsequently completed his surgical and orthopaedic training at the National University Hospital, Singapore. He is a fellowship-trained paediatric orthopaedic surgeon, having spent a year in Australia on a paediatric orthopaedic fellowship. Prof Hui is actively involved in undergraduate and postgraduate teaching at NUS. He is a member of numerous professional societies including the Paediatric Orthopaedic Society of North America, the Asia Pacific Orthopaedic Association and the Singapore Medical Association. Prof Hui is actively involved in clinical and basic science research.
Mr Kim David Raineri
Business Director, Lonza Bioscience Singapore
Kim David Raineri is the Business Director for Lonza Bioscience Singapore Pte Ltd. He is currently responsible for the ongoing operations of Lonza’s Cell Therapy contract manufacturing operation in Singapore Prior to this position, he was the Director of Operations for Lonza Walkersville (Maryland USA), where he managed multiple operations at the site including Cell Therapy contract manufacturing, manufacturing of Endotoxin detection (LAL) testing kits, powdered and liquid cell culture media, and other research products marketed under brand names Biowhittaker™, Clonetics™, and Poietics™. Prior to Lonza, he was with CryoLife Inc. (Georgia USA) as the Senior Manager of the Tissue Processing Lab. In this role, he was responsible for daily operations of human allograft manufacturing including human heart valves, vascular and orthopedic grafts. Kim Raineri has a Master’s of Business Administration from Kennesaw State University and Bachelors of Science from University of Miami.
Dr. Steve Oh
Senior Principal Scientist, Bioprocessing Technology Institute
Vice President, International Society of Cell Therapy (ISCT) Asia
Steve Oh, Ph.D. is the Senior Principal Scientist of the Stem Cell Group at the Bioprocessing Technology Institute (BTI), A*STAR. He has devoted his career to transforming stem cell bioprocesses from the petri dish to controlled bioreactors. The team now has a broad range of expertise in the production of human stem cells as therapeutic medicines; these include mesenchymal stem cells, pluripotent (induced and embryonic) stem cells, neuroprogenitors, cardiomyocytes, bone and cartilage differentiation and red blood cells. Current issues include creating robust serum free media for microcarrier cultures of these stem and differentiated cells; fashioning biodegradable microcarriers for transplantation and integrating the cell expansion process with complex multi-stage differentiation. He is also the Vice President Elect of the International Society of Cell Therapy (ISCT) Asia where he is involved in growing the society’s influence through educational technical webinars, policy making, conference organisation and increased participation of Asian scientists in cell therapy research and applications. Steve is also the Director of the Bioprocess Internship Programme which trains a cadre of highly skilled staff for the Biologics & Cell Therapy industry in Singapore.