Recipharm: Combatting Future Viral Threats with Vaccine Advances

Since the beginning of the COVID-19 pandemic, pharmaceutical organizations have experienced major changes, a prime example of which has been the rising requirement for collaborations on multiple different fronts across the industry. In some cases, companies have turned to doubling down on building more digital capabilities to enable virtual connectivity with healthcare professionals and patients rather than focusing on restructuring business units (1).

Many of the bio/pharma innovations that have been driven by the pandemic look like they are here for the long term, with a particular emphasis on vaccines that are being developed at the highest quality and astonishing production speeds. The future of vaccine development and the acceleration of novel delivery methods for these innovative therapies will be the most effective only if the industry manages to stay abreast of the rapid changes in technology. Some efficient tactics that will be brought into focus include improving manufacturing processes for quick vaccine delivery, reducing the need for multiple doses of a vaccine through boosting body immune response, and bettering transportation and storage of vaccines to reduce waste and improve access (2).

Pharmaceutical Technology spoke with experts at Recipharm and Kai Lipinski, Vibalogics (a Recipharm company), in this online exclusive about the impact of the pandemic on vaccine development.

Preparation and cohesion in vaccine development is a must

PharmTech: Since the start of the COVID-19 pandemic, how has vaccine development changed or improved for pharmaceutical companies?

Recipharm/Lipinski: COVID-19 highlighted that CDMOs (contract development manufacturing organizations) can provide immediate access to specialist sterile processing infrastructure and expertise to deliver rapid vaccine development.

Post-pandemic, pharma companies are more willing to work with CDMOs to speed up drug development. In fact, the global pharma outsourcing market—which includes CDMOs—is expected to be worth $108 billion by 2030, up from $70.5 billion in 2022 (3).

COVID-19 also provided proof-of-concept that mRNA and lipid nanoparticle (LNP)-based vaccines work and can be commercialized rapidly. Future vaccine development will show whether these technologies can be harnessed for other viruses, and whether they can contribute to optimizing global pandemic readiness.

Tech transfer and CDMOs

PharmTech: How have CDMOs changed since the pandemic, and is their focus still on technology transfer?

Recipharm/Lipinski: During the pandemic, many CDMOs invested heavily in their aseptic processing and sterile fill and finish capacity to support high-volume vaccine manufacturing. Harnessing novel prefabricated production line techniques, and single-use technologies, advanced CDMOs provided high-volume manufacture within a matter of months rather than years.

Many CDMOs also invested in expanding their integrated service offering for mRNA [messenger RNA] vaccines and other cutting-edge technologies, to provide comprehensive support across a product’s development journey to streamline the commercialization process.

Post-pandemic, technology transfer will continue to be a crucial part of the support CDMOs provide clients–clients will always need to hand over their project for it to progress.

Delivering new modalities

PharmTech: Are there any updates or new processes in DNA and mRNA vaccines for COVID-19/other vaccines?

Recipharm/Lipinski: For mRNA vaccines, there are new lyophilization techniques for vaccine formulations that offer better storage stability to minimize the need for specialist cryostorage capability. This reduces the cost and complexity of transit and storage, enabling wider distribution of vaccines to low-income countries.

Multivalent vaccines are being developed that target multiple variants of COVID-19 or other viruses—and can even target multiple viruses at the same time.

In 2022, we saw the emergence of circular RNA into the vaccine field with the aim of reducing vaccine cost. Different delivery routes are under investigation, such as intranasal delivery of mRNA vaccines.

Vaccine curation using different technologies

PharmTech: Have inhaled vaccines or vaccines in pills been discussed in recent days, and if not, are vaccines able to be curated into these types of technology?

Recipharm/Lipinski: Inhaled vaccines will certainly play a significant role when developing vaccines against airborne-transmissible infections. Offering the advantage of rapid and potentially pain-free administration, oral and nasal inhalation are being actively explored for vaccine delivery.

Recent studies suggest that the mucosal delivery of vaccines provides a better, longer-lasting effect than the traditional injection route, and can trigger robust protective immune responses at the predominant sites of pathogen infection (4). Inducing adaptive immunity at mucosal sites, involving secretory antibody responses and tissue-resident T cells can prevent an infection, particularly from coronavirus and influenza viruses, from establishing itself in the first place, protecting against primary infection as well as inter-human spread of disease.

The future of vaccine development

PharmTech: What do you hope for the future of vaccine development as we move past the height of the COVID-19 pandemic?

Recipharm/Lipinski: The pandemic highlighted the importance of easily modifiable vaccine technology platforms—such as mRNA—for speeding up future development and manufacturing. Not only can this approach allow large volumes of vaccine to be manufactured in the shortest timelines possible, it can also reduce regulatory burdens and timelines due to proven safety and stability data.

Post-COVID, we can also expect new delivery routes to be explored to speed up our future mass vaccination campaigns. Inhaled vaccines, for instance, can be easily self-administered by the patient in their home, potentially increasing the number of people vaccinated each day, as patients can treat themselves.

References

1. McKinsey & Company. A New Operating Model for Pharma: How the Pandemic Has Influenced Priorities. McKinsey & Company (accessed 2023-1-10).

2. ABPI. The Future of Vaccines. https://www.abpi.org.uk/value-and-access/vaccines/the-future-of-vaccines/ (accessed 2023-1-10).

3. Research and Markets. Biotechnology & Pharmaceutical Services Outsourcing Market Size, Share & Trends Analysis Report by Services (Consulting, Auditing And Assessment, Regulatory Affairs) by End Use (Pharma, Biotech), by Region and Segment Forecasts, 2022-2030. Researchandmarkets.com. https://www.researchandmarkets.com/reports/5505273/biotechnology-and-pharmaceutical-services?gclid=CjwKCAiAnZCdBhBmEiwA8nDQxbxFHasaU4DYOa0NYBOLxyBjxWRKt9nhGcp56a9p5T3EzrOFos1oXBoCGRUQAvD_BwE

4. Lavelle, C. and Ward, R.W. Mucosal Vaccines-fortifying the Frontiers. Nature Reviews Immunology 2022, 236-250 https://www.nature.com/articles/s41577-021-00583-2