RE: A2P37 Oct 2021 00:58
I don't think so Fruits from teh RNS.
WManufacturing pharmaceutical products has been very challenging due to COVID-19, with shortages in key ingredients, components, equipment and manufacturing slots. Despite these challenges, during 2021, Synairgen has undertaken the following activities:
· Process qualification commercial scale manufacturing batches of the drug substance (the raw ingredient IFN-beta) have been made with our partner Akron Biotechnology;
· Drug product in pre-filled glass syringes (the finished format, ready-to-use) has been made in partnership with Catalent at commercial supportive scale;
· Completed a drug product manufacturing commercial scale batch (currently under testing) using polyethylener blow-fill-seal container technology to mitigate against the global supply chain shortages of medical grade glass and the reduction of available syringe filling manufacturing slots caused by the number of vaccines and therapeutics in development for COVID-19;
· Long term stability studies ongoing for both drug substance and drug product to support regulatory submissions; and
· Built inventory of certain specific long-lead time items needed to administer the drug to patients."
The stability studies are to support regulatory approval.