Critical Pharmaceuticals Ltd., BioCity Nottingham, Pennyfoot Street, Nottingham NG1 1GF, UK.
Int J Pharm. 2011 Jul 15;413(1-2):147-54. doi: 10.1016/j.ijpharm.2011.04.053. Epub 2011 Apr 28.
Single shot vaccines of tetanus toxoid (TT) were manufactured using the NanoMix process - a low temperature solvent free encapsulation technology using supercritical fluids. The formulations were injected into mice, and compared to multiple injections of a commercially available alum adsorbed TT vaccine. After 5 months the antibody titres were found to be similar for both the alum adsorbed and microparticle formulations, demonstrating for the first time the potential of formulating antigens in PLA microparticles using the supercritical fluid (NanoMix) technique to produce single shot vaccines. The results are likely to be due to the maintenance of toxoid bioactivity and some degree of sustained release of the encapsulated antigens, resulting in repeated stimulation of antigen presenting cells eliminating the need for multiple immunisations. This demonstrates the potential of this supercritical fluid processing technique to reduce the need for booster doses in a vaccine regimen.
破伤风类毒素(TT)的单剂疫苗是使用 NanoMix 工艺制造的 - 这是一种使用超临界流体的低温无溶剂封装技术。将这些配方注入小鼠体内,并与市售的吸附在明矾上的 TT 疫苗进行多次注射进行比较。五个月后,发现明矾吸附和微粒制剂的抗体效价相似,首次证明了使用超临界流体(NanoMix)技术在 PLA 微粒中配制抗原以生产单剂疫苗的潜力。结果可能是由于类毒素生物活性的维持和封装抗原的某种程度的持续释放,导致抗原呈递细胞的反复刺激,从而消除了多次免疫的需要。这表明这种超临界流体处理技术有可能减少疫苗方案中加强剂量的需求。