AFRY AB The Covid-19 pandemic continues, and the situation remains serious, both in Europe and globally. The world's population is waiting for more vaccines to be approved. Lena Fälting and Christina Olausson, Life Science consultants at AFRY, are two people who are highly involved in this process.
AFRY's client Novavax is a biotech company based in the United States. The company's main purpose is to develop new vaccines against emerging infectious diseases. They have now come a long way: their candidate vaccine for COVID-19 has been tested on humans on a large scale in several ongoing clinical studies. The vaccine has shown a high protective effect, even against the newer British and South African strains of the virus.
Most likely, the vaccine can be reviewed by European Medicines Agency this spring and be ready for launch by summer 2021. Then the world will have access to another effective Covid 19-vaccine, which can be compared to Pfizer's and Moderna's.
This is truly exciting, and possibly the most important assignment we've ever been involved in," says Lena Fälting, pharmacist and project manager. "We act as so-called Tech Transfer Project Managers at Novavax in Uppsala, Sweden. This means that we support the client with the transfer of technical and analytical know-how for the production of adjuvant, which needs to be produced on a larger scale to be added to Novavax' Covid-19 vaccine.
The adjuvant is a central ingredient in the vaccine. Its purpose is to increase the immune system's ability to recognise and fight the virus.
Lena's and Christina's assignment is to run the transfer activities that are done internally at Novavax, and to coordinate this work with contract manufacturers across Europe and the USA. The recipient must be able to produce the same product, with the same quality, as the sender.
"The collaboration with all the contract manufacturers in the world is extensive and complex, so it's a big challenge to tackle, but at the same time such an exciting process to be a part of,2 says Christina Olausson, project manager, AFRY.
The production is complicated, and all parts of the process must be coordinated and controlled - which makes the project organisationally challenging. As a number of different countries are involved, it's important to keep track of the different requirements that apply to pharmaceutical manufacturing in each nation. They can be designed in various ways, but the purpose remains the same: guaranteeing patient safety.
Technical transfer contains a lot of analysis and validation work, which consumes a lot of time and resources. To avoid doing the same work twice, you need to be able to interpret the different regulations and identify which requirements correspond to each other.
Lena and Christina have already had long careers in the pharmaceutical industry to lean on; careers that have given them the right expertise and experience to succeed in the important assignment at Novavax. Coordinating is largely about getting the right information to the right person, hence speaking the language of the pharmaceutical industry is a great advantage.
"The combination of our experiences has paved the way for a good collaboration, which is key to success in this assignment," says Lena.
Christina adds:
"It feels really good to get to be a part of this: helping the world get access to another vaccine against Covid-19. It's super intense and exciting to communicate with the different manufacturers around the world. Both the pandemic and the fight against it is a global mission. Together, we are working for a healthy and strong population."
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ÅF Pöyry AB published this content on 11 February 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 11 February 2021 09:14:01 UTC.
