Case
Experience and expertise in the fight against COVID-19
The COVID-19 pandemic has created a high-pressure situation and new approaches for all the pharmaceutical companies that are developing COVID-19 vaccines. One of these companies is Novavax, which Semcon has supported in the work of, among other things, scaling up production, so that the company will be ready to deliver the vaccine, assuming it is approved by regulators.
CustomerNovavax
IndustryLife Science
CompetencesQuality ManagementProject ManagementValidation
Background
Novavax is an American biotechnology company specialising in developing vaccines and vaccine adjuvants. In January 2020, the company announced that it had begun work on developing a vaccine against SARS-CoV2, the virus that causes COVID-19. One year later, in January 2021, Novavax published data from one of its Phase III studies.
Experienced life science consultants
Developing a vaccine is normally an extensive task that takes several years, but a pandemic means a fight against the clock and requires new approaches. For Novavax, which has a facility in Uppsala, the development of its COVID-19 vaccine candidate meant an increased and greater need for support. Semcon’s collaboration with Novavax goes back many years and has enabled experienced consultants in our life science group to quickly provide support to Novavax. One of the consultants is Sara Petrell, who started supporting Novavax in May 2020. Sara came in as project manager and has worked to scale up production so that Novavax is ready to produce large amounts of the vaccine’s adjuvant component to be ready on the day it is approved.
“I am very happy to be part of and contribute to an organisation that is doing its utmost to contain the pandemic with the goal of saving lives. Despite the fact that Novavax AB has almost doubled its staff in one year, it has managed to onboard everyone well. Novavax has a strong team spirit and every single team member shows an enormous commitment and willingness to solve all the challenges that such an extensive and rapid upscaling entails”, said Sara Petrell, Project Manager in life science at Semcon.
Production, validation and documentation
Around the work on the vaccine itself, there is feverish activity to prepare large-scale production and at the same time an intensive work with validation and documentation. In parallel with everything related to the COVID-19 vaccine candidate, Novavax’s other projects need to run according to plan. The outcome of all of this is a large increase in the workforce in a very short time, which places demands on the organisation. Novavax has recruited both employees and consultants, several of whom are from Semcon. Semcon’s experience and practice of quickly getting acquainted with a new organisation is valuable when time is short.
Elin Sins is an Area Manager at Semcon in Uppsala. She has worked with Novavax for five years and has matched their rapidly increasing needs with the right people at Semcon. This has involved competence in validation, project management, analytical chemistry, quality control and production.
Novavax’s’ COVID-19 vaccine candidate is currently (April 2021 ed. note) in Phase III trials, one in the United Kingdom and one combined in the USA and Mexico. The vaccine was the first COVID-19 vaccine candidate to have data against both the British and South African variants of COVID-19 in addition to the original strain.
