Innovative vaccine manufacturing enables the delivery of vaccines to the developing world



In this podcast, we interviewed Dr. Alex Chatel, Product Manager, Viral Applications, Univercells about the biggest challenges facing vaccine manufacturing today, why it is so difficult to manufacture and deliver vaccines to the developing world and how a novel technology with the support of the Gates Foundation is poised to address these challenges.

I began the interview by asking Dr. Chatel what he sees as the biggest challenges facing vaccine manufacturing today. He stated that the main challenge is manufacturing capacity and as a result, vaccine supply is too low compared to what is needed. Another big problem is that vaccines are being manufactured today using technologies that are outdated. These inefficient vaccine manufacturing methods cause both captial expenditure and operating expenses to be higher than necessary. Unfortunately the cost of production of vaccines will remain too high unless a change in manufacturing is implemented.

Next, I asked him why it is difficult to manufacture and distribute vaccines to the developing world? He explained that the capacity and outdated technology problems are issues in both the developed and developing world. However, the developing world has the additional challenge of distribution, specifically cold chain. Maintaining product stability is obviously important to maintaining efficacy, but cold chain distribution is often hard to maintain from manufacture to delivery in some of these areas. Some companies are working on developing more stable formulations for travel and other solutions. Administration of the vaccine and managing the proper handling and disposal of syringes is also difficult and presents the risk of spreading infectious disease.

We then discussed how Univercells’ Scale-X technology helps enable vaccines delivery worldwide? He explained that most viral vaccines are manufactured using adherent cells and thus they need a point of anchorage for production. Currently support matrices used in vaccine manufacturing include microcarriers in bioreactors or static systems such as roller bottles or stacked plate equipment. Scale-X couples the advantage of having the environmental culture control found in bioreactors with the gentle growth environment of static systems. In this system, the cells adhere to the support matrix, while nutrients in the culture media are circulated around the cells gently. On of the key advantages of this approach is that a high level of production can be achieved in a small footprint of equipment. This enables better facility design and utilization, plus capital expenditures are much less than traditional manufacturing technologies where more facility space and environmental controls are necessary.

Another advantage that Alex shared is that the equipment is small and fully automated with only a small number of operations required to run the system. This provides a much less risky and less costly alternative to traditional manufacturing where more manual operations increase risk of error and require more labor to operate. In addition, the Scale-X technology is highly scalable and permits easy and quick scale up to larger volumes. Cells receive a consistent experience at both small and large scales, so scale up is quite simple.

Alex then explained how Univercells has demonstrate success of the platform through hundreds of experiments using vero cells to produce polio vaccine. Through a grant given by the Bill and Melinda Gates foundation, they have looked at improving the manufacturing of the polio vaccine from R&D to pilot scale and are now ready to scale up to large scale production. They plan to manufacture their first lot of clinical material and have also been gathering experience with other cell types and viruses for vaccine manufacturing and the manufacturing of viral vectors for cell and gene therapy applications.

I then asked if Alex could tell me a little more about their work with the Gates Foundation. He said that one of the goals of the Gates Foundation is a focus on eradication of polio from the planet and they fund programs to achieve this goal. One area of their funding is aimed at disruptive manufacturing technologies, which Scale-X represents. The goal here being to bring new technologies to vaccine manufacturing that will drive down the cost of vaccine manufacturing and furthermore make it more commercially interesting for companies to develop and produce new vaccines. Also, there is a need to fill the current supply gap for existing vaccines of interest in order to reach worldwide vaccination targets. Univercells received their grant in 2016 and will have the first lot of clinical material with the ultimate goal of manufacturing polio vaccine at large scale.

I went on to ask Alex how he envisions Scale-X being employed in the developing world. He said one of the key features of the technology is its ability to integrate with another product to create a micro facility. In this micro facility both cell culture production of viral material and also purification could occur within a small environment. This would cause a drastic reduction in required manufacturing footprint and the entire system could be quickly installed in countries where there might not be the existing manufacturing structure that exists in the developed world. The main barrier to entry for developing world that wants to manufacture its own vaccines is the cost of building a manufacturing facility. With the micro facility, these countries could consider manufacturing their own vaccines rather than purchasing from pharmaceutical companies.

Last, I asked Alex if he had anything to add for listeners. He said that one of the cool things about this technology is that it represents a step change in how vaccines are manufactured now and in the future. Once implemented it would be completely different to what we are used to and presents the opportunity to bring more modern technologies to vaccine manufacturing -an industrial revolution of vaccine manufacturing. Ultimately though the main benefit is that disease eradication targets through vaccination can be more easily met.


Optimizing Fed Batch Culture – Developing New Tools and Methods to Improve Production



We interviewed Dr. Aline Zimmer, Head of R&D, Advanced Cell Culture Technologies at Merck about the importance of optimizing fed batch cell culture for successful biomanufacturing. Aline discussed how her team has developing new tools and methods for optimizing fed batch culture and the impact this has had on productivity and product quality.


Using cell culture models of endocrine resistance to improve triple positive breast cancer treatment options.



Cell Culture Hero, Dr. Hillary Stires discusses her work researching better treatment options for triple positive breast cancer patients. She explains how the use of cell culture modeling helps drive her research. She also talks about her experience as a cell culture hero and her passion for the scicomm movement on social media platforms. 


Integrating bioprocessing steps to improve efficiency and reduce cost



In this podcast, we interviewed Dr. Rick Morris, Senior Vice President, R&D, Biotech, Pall Life Sciences, about integrating bioprocessing steps to improve efficiency, reduce cost and address current challenges in the industry.  Specifically, we looked at how upstream and downstream can be more integrated and how to increase integration in existing facilities.

View show notes at cellculturedish.com/integrating-bioprocessing-steps-to-improve-efficiency-and-reduce-cost/


Expediting cell and gene therapy workflows



In this podcast, we interviewed Mr. Dave Eansor President of the Protein Sciences Segment at Bio-Techne and Dr. Sean Kevlahan, Senior Director of Cell and Gene Therapy at Bio-Techne about new technologies that can be implemented to expedite cell and gene therapy workflows and facilitate the path from bench to clinic.

View show notes at cellculturedish.com/expediting-cell-and-gene-therapy-workflows/


A Road Map for Efficient Fed-Batch Cell Culture Optimization



In this podcast, we interviewed Dr. Andreas Castan, Principal Scientist at GE Healthcare Life Sciences about the most efficient ways to optimize fed-batch cell culture production for CHO-based antibodies. This included a discussion of media vs. feed strategies, incorporating critical quality attributes, evaluating the impact of optimizing on downstream processing and more.

View show notes at cellculturedish.com/efficient-fed-batch-cell-culture-optimization/


Viral Vector Manufacturing for Gene Therapy



In this podcast, we interviewed Dr. Mats Lundgren, Ph.D. Customer Applications Director, Life Sciences, GE Healthcare, Sweden about developing platform processes for viral vector manufacturing and Mats describes a recently developed platform process for adenovirus production. 

View show notes at cellculturedish.com/viral-vector-manufacturing-for-gene-therapy-developing-a-platform-process/


Key Considerations in Gene Therapy Manufacturing for Commercialization – A panel discussion



This podcast is a recording from the panel discussion that I moderated at this year’s Cell and Gene Therapy Bioprocessing and Commercialization Conference. The discussion covers the latest in gene therapy manufacturing strategies, analytical analysis, cost of goods and key regulatory considerations.

View show notes at cellculturedish.com/key-considerations-gene-therapy-manufacturing-commercialization-panel-discussion/


Closed System Cell Therapy Manufacturing – Moving from the lab to clinical and commercial production



In this podcast, we conducted a panel discussion on key considerations for moving cell therapies from lab to commercial manufacturing, including the benefits of manufacturing in a closed system. We also discussed what were some of the key hurdles and possible solutions associated with transitioning to clinical and commercial cell therapy manufacturing.

View show notes at cellculturedish.com/closed-system-cell-therapy-manufacturing-moving-lab-clinical-commercial-production/


Start With The End In Mind. How to facilitate transfer from non-GMP to GMP



In this podcast, we interviewed Avril Vermunt, bioprocess hardware specialist at GE healthcare about transferring a process from a non-GMP to a GMP environment, particularly how resource-intensive it is for process development and manufacturing groups. Avril has several years of experience working in the technology transfer group at a large pharmaceutical company. We discussed with her best practices and how being proactive and one step ahead can make the process more seamless.

View show notes at downstreamcolumn.com/podcast/facilitate-transfer-from-non-gmp-to-gmp-manufacturing/