Novartis Vaccines and Diagnostics, Cambridge, MA 02139, USA.
Expert Rev Vaccines. 2011 Dec;10(12):1731-42. doi: 10.1586/erv.11.126.
Biodegradable polymeric microparticles of poly(lactide-co-glycolide) (PLG) have been extensively evaluated for drug delivery and vaccine applications over the last three decades. Despite a wealth of studies on the use of PLG microparticles in vaccines through controlled release of antigens, there is no commercial PLG-based vaccine as yet. The key challenge that prevented the development of PLG microparticles as commercial vaccines was the instability of encapsulated antigen. Over the years, advancements were made towards maintaining antigen integrity during PLG microparticle preparation and sterilization. In parallel and independently, development of PLG microparticles as therapeutic commercial products established PLG with an excellent safety record in humans, and as a suitable candidate for next-generation vaccines. Through the combination of Toll-like receptor agonist encapsulation and surface adsorption of antigen, PLG microparticles can be used as a vaccine adjuvant to address unmet medical needs, such as vaccines against HIV, malaria and TB. With strategic development of PLG-based vaccines, PLG microparticles can offer advantages over the conventional vaccine adjuvants allowing commercial development of this adjuvant.
在过去的三十年中，聚（乳酸-共-乙醇酸）（PLG）的可生物降解聚合物微球已被广泛评估用于药物输送和疫苗应用。尽管已有大量关于通过控制抗原释放将 PLG 微球用于疫苗的研究，但目前尚无基于 PLG 的商业疫苗。阻止 PLG 微球作为商业疫苗开发的关键挑战是包封抗原的不稳定性。多年来，在 PLG 微球制备和灭菌过程中保持抗原完整性方面取得了进展。与此同时，作为治疗性商业产品的 PLG 微球的开发在人类中确立了 PLG 极佳的安全性记录，并成为下一代疫苗的合适候选者。通过 TLR 激动剂包封和抗原表面吸附的结合，PLG 微球可用作疫苗佐剂，以解决未满足的医疗需求，如针对 HIV、疟疾和结核病的疫苗。通过战略性地开发基于 PLG 的疫苗，PLG 微球可以提供优于传统疫苗佐剂的优势，从而促进这种佐剂的商业开发。
