Stablepharma has achieved a milestone in its Td-StablevaX-M project, the company says, having demonstrated stability of the reformulated Td vaccine for up to 10 months at 45ºC, in collaboration with strategic partner BB–NCIPD.
Td-StablevaX-M is a pre-filled disposable syringe containing dry stabilised tetanus diptheria vaccine for administration by injection following rehydration. The company has been able to demonstrate long-term stability at high temperatures, addressing a significant problem in vaccine distribution and the cold-chain.
Td-StablevaX-M is a reformulation of BB–NCIPD Tetadif vaccine, which is one of the five WHO pre-qualified Td vaccines, distributed across many countries. Currently Tetadif is in liquid form and indicated to be kept between 2ºC and 8ºC and to avoid freezing.
“Results of the animal potency tests are ground-breaking, showing that StablevaX-M™ Td vaccine remains thermostable and as potent as the reference vaccine after exposure to 45°C for up to 10 months,” Özgür Tuncer, CEO & Executive Chair, Stablepharma.
Arcadio G. de Castro PhD, CSO, Stablepharma, explained: “We designed an accelerated stability study with our European partner BB–NCIPD Ltd, to evaluate stability after 10 months at +45ºC of Td vaccine, which was reformulated as StablevaX-M. We have evaluated adjuvant and toxoid integrity as well as in vivo potency. Potency tests were carried out under a fully qualified quality system following Pharmacopeia guidelines, and involved evaluation of the protection confered to animals by the vaccine against a lethal dose of the tetanus and diptheria toxins. The potency tests are the same as those used for batch release of commercial liquid vaccine, which under the same conditions, were found to completely lose effectiveness.”
“We are very happy with the observed results, as they exceed the current European Medicines Agency (EMA) requirement set for a ‘fridge-free’ pharmaceutical product, which is to demonstrate stability at 40°C for 6 months”.
Vaccine structural integrity was demonstrated by enzyme linked immunoassay (ELISA) tests developed in collaboration with UK’s NIBSC showing that after 10 months at +45°C, tetanus and diphtheria toxoids in the control liquid vaccine were fully degraded while they remained unchanged in Td-StablevaX-M.
