The global Covid-19 pandemic has forced us to put our lives on hold, and a vaccine is the most likely route back to normality. Vaccine development is in the limelight, and our need for one has led us to search for ways to speed up the process.
The UK was the first European country to approve a Covid-19 vaccine in December 2020. However, it took almost a year to reach this point, as vaccine development is a long and complex process. Typically, each pathogen needs its own vaccine manufacturing process. Stringent regulations and the lack of incentives make the process even more challenging.
Various approaches could drive the industry forward. New and improved technologies have the potential to speed up and simplify vaccine development. The creativity and expertise of biotechs have led to their prominent role in the development of many vaccines, including those for Covid-19.
Implementing new technologies
Improved platforms and rapid testing that streamlines safety and quality assessments could transform vaccine development. I spoke with experts at Merck to find out more.
mRNA technology is a novel vaccine platform that has been used for the first two Covid-19 vaccines to be approved. A cell-free system produces mRNA by in vitro transcription, which is delivered into our cells in lipid nanoparticles and works as a vaccine by mimicking mature mRNA. According to Nargisse El Hajjami, Associate Director of the Cell and Gene Therapy Segment at Merck, “mRNA could become the most promising option to overcome pandemics.”
The speed at which an mRNA vaccine can be designed could make it vital to pandemic responses. “Just two months after identifying the coronavirus (Sars-Cov-2) sequence, the first mRNA vaccine was designed and entered human clinical trials,” El Hajjami highlighted. Other benefits include production without cell culture, fewer safety concerns vs DNA technology, and the potential to be more cost-effective than current approaches.
Anissa Boumlic, Director and Head of the Global Vaccine and Plasma Segments at Merck, described the issues yet to be resolved. “The industry needs to improve the formulations to increase mRNA stability. The optimization and industrialization of mRNA processes are still in progress ⎼ most previous work has been done at a relatively small scale.” Merck is well-positioned to support, with over 20 years’ experience working on mRNA therapies, and expertise in lipid formulations.
Challenges remain for the scale-up, transportation, and storage of mRNA vaccines. However, an mRNA Covid-19 vaccine could be the case study needed to change vaccine development and manufacturing in the future.
Optimizing current technologies
Viral vectors have been around for decades. They were originally used to transfer genes, but the Ebola outbreak in 2014 accelerated their establishment as a vaccine platform. Several companies are adopting the technology for a Covid-19 vaccine. However, “viral vectors are yet to be optimized to increase their process robustness, efficiency, and scalability,” Boumlic explained.
Merck has first-hand experience in supporting companies using viral vectors through early-stage development and GMP manufacturing. It offers single-use, purification, and biosafety technologies, and trains scientists in developing processes and solving scale-up bottlenecks. This was demonstrated by a vaccine development collaboration with the Jenner Institute.
Speeding up biosafety testing
One bottleneck during vaccine development is meeting stringent safety regulations. An important part of the regulations is biosafety testing, which ensures that the cell lines, virus banks, biological raw materials, and process intermediates used to produce a new vaccine are free of contamination.
Kathryn Remington, Technical Consultant at Merck, described what goes into testing a new vaccine. “GMP cell and virus bank manufacturing, cell line and virus bank characterization, raw material testing, bulk harvest lot release testing, final product release testing, and viral clearance studies.” Experience in conducting compliant studies and access to appropriate technologies are important for meeting regulatory requirements.
Merck has developed the Blazar™ platform, which screens for a broader range of viral contaminants than more traditional approaches. “The Blazar™ platform couples the speed and sensitivity of traditional PCR with the breadth of detection of next-generation sequencing,” explained Adam Inche, Strategy Manager at Merck.
The first application of the platform, the Blazar™ Rodent Virus Panel, replaces in vivo mouse, hamster, and rat antibody production assays. “Substituting the antibody production assays during cell line characterization can reduce testing time by up to 80%, accelerating entry into Phase I. Additionally, this platform helps companies fulfill their ethical obligations by reducing the use of animal models,” Inche said.
Collaborating with biotechs
Biotechs have the qualities to respond quickly to a pandemic, but they may lack regulatory, commercial, and industrial experience. Merck guides biotechs from very early development to the commercialization and industrialization of a new vaccine, with state-of-the-art technologies, services, and expert advice.
Early-stage biotechs may not have interacted with regulatory authorities, but the Life Science industry is likely to have supported many regulatory submissions. “We can provide guidance according to the most recent regulatory guidance documents, and we understand the testing that is required,” Remington explained.
Additionally, the Life Science industry can give biotechs access to technologies that help them move through vaccine development more quickly. “Speed to the clinic is of critical importance for biotechs developing vaccines; therefore, any means to accelerate timelines will be of enormous benefit,” Inche highlighted.
Merck’s Advanced Biotech Grant Program has offered products, services, consultation, and training to early-stage biotechs around the world for over six years. It has provided over €2M in development goods to US, European, and Asian companies. The program is open to all biotechs, including vaccine developers.
A greater focus on vaccines
Vaccines have not received as much attention as other fields, but pandemics are changing that. Traditional vaccine development methods won’t go away, but new platforms and technologies are becoming available. Increased investment and leadership should boost research, modernize processes, and decentralize manufacturing, facilitating a pandemic response that is quicker and easier to deploy.
Find out more about vaccine development at merckmillipore.com/vaccines.
*The life science business of Merck operates as MilliporeSigma in the US and Canada. Merck is a trademark of Merck KGaA, Darmstadt, Germany.
Images via Shutterstock.com and Merck.