Advanced dosage forms of biologic medicines, the demands,innovation and business models in the chang

来源 :第二届全国生物颗粒学术研讨会、第三届国际工业药学和临床药学研讨会暨第一届岭南国际药学大会 | 被引量 : 0次 | 上传用户:yy4733
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  To meet the urgent unmet needs in advanced dosage forms of increasing biologic medicines,we developed two platform technologies for formulating proteins and peptides,sustained-release microspheres and phase-transition microneedle patch.The former offers a simplified process to microencapsulate proteins and peptides by a self-consistent design for which the produced microspheres are uniform in size and the number of unit operations is reduced from five (5) to two (2).This simplified process may easily be incorporated in a sterile hood for aseptic production.Moreover, this formulation process is free of the dynamic breaking and re-fusing of embryonic microspheres involved in conventional microencapsulation, for which delicate proteins will not contact with the water-oil interface, a factor known to denature proteins.The phase-transition microneedle (PTM) patch overcomes the limitations of previously reported systems such as the lack of drug loading capacity of solid microneedles, the easiness of breaking and blocking of hollow microneedles, and the polymer deposition to the skin from soluble microneedles.Preclinical efficacy and PK studies in animal models indicate that PTM may be an idea dosage form for non-injection administration of insulin, a medicine requiring multiple doses per day.While the recent reform in food and drug regulation policy in China has offered a bullish climate for pharmaceutical innovation, people seem to have not recognized the hint that the market for developing technologies is still far from maturity.Any technology, no matter how great it is, is worthless in China before it has reached the final step.People in the industry and related government departments do not understand that pharmaceutical innovation is a relay race in which the first runner (university research teams) cannot reach the fourth one (pharmaceutical manufacturer).The critical shortage in Chinese pharmaceutical industry is the second rurmer (VC for earlier stage technologies) and the third player (R&D start-ups funded by he earlier stage VCs).
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