Croda, Novasep part of key COVID vaccines

Both Croda International and Novasep are involved in some of the vaccines nearing approval for use in the treatment of COVID-19 it has emerged. This follows on from many other announcements of development agreements involving other fine chemical companies earlier in the year.

Via its newly acquired subsidiary, Avanti Polar Lipids, Croda has agreed to supply novel excipients used in the manufacture of Pfizer’s mRNA COVID-19 vaccine candidate, for which 90% effectiveness has been claimed in human tests. The five-year deal includes an initial supply contract for four component excipients for the first three years.

Croda said that it had been working with Avanti before and since the acquisition “to refine the complex processes involved in achieving the volumes of high-purity excipients required by its pharmaceutical customers”. It has reprioritised investment, resources and other projects over the last few months to focus on the delivery of this project.

Meanwhile, Novasep has signed a multi-year master supply and development agreement with AstraZeneca to support large-scale production of the active substance of the adenovirus vector-based COVID-19 vaccine candidate, AZD1222. This follows an initial agreement signed in June. Novasep will produce the active substance at its site in Seneffe, Belgium. The company expects to increase its workforce from 280 to close to 400 by 2021 to support this project. The project is also supported by the Inclusive Alliance for Vaccines, comprising France, Germany, Italy and the Netherlands.

Another candidate that has moved closer to fruition following highly promising interim Phase III clinical trial data is that developed by Moderna’s mRNA-1273. Nearly 95% effectiveness has been claimed for it in recent trials. Under a ten-year strategic collaboration agreement that was agreed in May, Lonza is carrying out large-scale manufacture at Portsmouth, New Hampshire, and expects to begin production at its main site in Visp, Switzerland, by 2021. This will amount to 400 million doses/year. CordenPharma is supplying the lipid excipients.

During the summer, Sterling Pharma Solutions agreed to carry out final purification of drug product for Moleculin Biotech’s WP1122 drug candidate from its site in Cary, North Carolina; while, Novavax reached separate agreements with Fujifilm Diosynth Biotechnologies and AGC Biologics to manufacture the drug bulk substance and the saponin-based Matrix-M adjuvant respectively for its COVID-19 vaccine candidate, NVX-CoV2373.

In addition, AMRI was named as the second US API supplier for ViralClear Pharmaceuticals, which is investigating the potential of merimepodib to fight COVID-19, either as a stand-alone treatment or in combination with other antiviral agents or immune modulators. Merimepodib was previously developed for chronic hepatitis C and psoriasis by Vertex.