Commentary

Perspectives of Vaccine Development and Manufacture

By Tia Byer |
01 November 2021
What does the future of the vaccine look like? Tony D’Amore and Yan-Ping Yang of Sanofi Pasteur take us through the ever-evolving vaccine development and manufacturing landscape.

By Tony D’Amore, Vice President of Product Research and Development, and Yan-Ping Yang, Associate VP, Head of Bioprocess R&D North America at Sanofi Pasteur

Transcribed by Tia Byer

The growing demand for vaccines in the global market has skyrocketed in 2021. In addition to the ground- breaking COVID-19 vaccines to fight against the pandemic, there are currently well over 120 new products in the development pipeline. The vaccine market is steadily growing at a CAGR (Compound annual growth rate) of 11.02%, and it is expected to reach a value of over 100 billion USD by 2028. Over the years, the number of large pharmaceutical companies that have acquired vaccine divisions has and will continue to increase exponentially. Vaccines have become a growth engine for the pharmaceutical industry.

The Vaccine Industry: Diversity and Complexity

Unlike monoclonal antibodies, vaccines are highly diverse, with wide variations in properties and few established platform processes. Examples of the different types of vaccines include live attenuated, inactivated, subunit, recombinant, polysaccharide, toxoid, and conjugate vaccines, all of which require different levels of product characterisation. Vaccines are manufactured via a wide variety of cell substrates, and the industry is increasingly finding that novel antigens often require novel substrates, which was evident during the development of COVID-19 vaccines. Some of the most common cell substrates used for vaccine development and manufacture includes mammalian, insect, microbial, fungal, and avian cell lines. The recent success of using the mRNA platform to produce COVID-19 vaccines has added one more tool to this list for new vaccine development and manufacturing technologies.

Development Challenges and Drives for Change:

When it comes to developing new vaccines or improving the existing vaccines, several industry and manufacturing challenges require consideration. Time and investment pressure is especially important and, on average, can take up to 10 to 12 years to bring a vaccine to the market (Covid-19 vaccine aside), while there is only a 15 to 20% success rate in taking a product from discovery to successful launch. The industry continues to face increasing pressure on the “return of investment”, as manufacturing costs represent around 15 to 25% of the total cost of goods. Supply and regulatory pressure also continue to grow, with the need for complex processes to meet the diversity of market demands plus increased regulatory scrutiny. Financial considerations present a particular challenge as the cost of vaccine development can be up to 1 billion USD from start to finish. Going forward, the search for new cost-effective techniques to accelerate new vaccines is the key driver in a global initiative to produce more and improved vaccines for a changing infectious disease landscape. 

Advancement of Development Technologies:

The implementation of innovative bioprocess technology has improved the rate of vaccine development over the past decades and advances in process analytical technology (PAT) facilitated vaccine development. When 70% of a vaccine’s production time is dedicated to testing and process monitoring, PAT enables on-line and in-line functioning to measure key product attributes in real-time. Another promising technology is the high-throughput downstream process development and analytical capability. Examples include the TECAN Freedom EVO Liquid handling robot, the Zephyr Compact liquid handling, Microfluidic electrophoresis Caliper LabChip GXII, and the ForteBio Octet RED96 System. All use high-throughput technology to increase the productivity and efficiency of product development. Additionally, these platforms provide significant savings on materials and build broader process knowledge.

Single-use disposable technology has now been fully embraced by the vaccine industry and entered the mainstream of bioprocessing. What makes disposable technology so attractive is its ability to enable rapid process development. With a shortened installation time and less technical complexity, disposable technology allows for reduced cleaning and preparation work and expands the number of new tools available to users. A further benefit is that it provides customisation and a fit-for-purpose need. Advanced analytical methods have also brought new light to vaccine development. Analytics is a core and emerging activity that contributes to the understanding of the product. New analytical technologies are divided into four main areas: nucleic acid detection, antigenicity and affinity, mass spectrometry, and particle sizing. Such technologies improve product understanding and provide rapid analytical results which enable timely feedback to process development.

Integrated continuous bioprocesses, although still in their infancy, show encouraging promise for vaccine manufacturing. They possess the advantage of minimum downtime combined with low cycle time and a high plant utilisation rate. With a decreased facility footprint and smaller equipment, these technologies ensure consistent product quality due to their steady-state operation. Integrated continuous bioprocesses additionally provide an increased degree of process control and automation while reducing COGs and CAPEX.

Look into the Future:

Overcoming vaccine development challenges shortens the time for proof of concept, allowing manufacturers to get vaccine products to the market faster. The recent examples of Covid-19 vaccine development to address the pandemic is an example of how technology can drive faster vaccine development. Other opportunities include a better understanding of legacy vaccine products, increasing process robustness to ensure product quality and supply. Not only will the next generation of cutting-edge technologies increase speed and reduce complexity, but they will significantly improve efficacy and flexibility. Accelerating new vaccine development will increase R&D productivity and embracing technological innovation will prepare the vaccine industry for the future.

Speaker Biographies

Tony D’Amore, Vice President of Product Research and Development at Sanofi Pasteur – Dr. Tony D’Amore holds a PhD in Biochemistry from the University of Windsor and an MBA from Wilfred Laurier University. D’Amore joined Sanofi Pasteur in 1994 as a Purification Scientist and has taken on a number of leadership roles within the Company. Since July 2015, D’Amore is in the role of Vice-President, Global Product Research & Development, responsible for process and analytical development, the manufacture of clinical trial material and the delivery of clinical supplies to the clinical trial sites. D’Amore leads a global group of over 500 staff.

Yan-Ping Yang, Associate VP, Head of Bioprocess R&D North America at Sanofi Pasteur Dr. Yan-ping Yang received PhD in Biochemistry from the University of Missouri-Columbia, USA, and joined Sanofi Pasteur in 1989 with increasing roles and responsibilities. She has been involved in various bacterial and viral vaccine development projects with numerous patents and publications. Since 2014, Yang has been the Head of Bioprocess R&D in North America, overseeing a department of ~100 staff in its efforts to develop vaccine manufacturing processes (upstream, downstream, formulation and stability, and cGMP production of DS and DP) to provide materials for preclinical and clinical studies up to phase III.

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