New Research Revealed on a Promising Functional Alternative to Surfactants within Biologic Formulations
Webinar

New Research Revealed on a Promising Functional Alternative to Surfactants within Biologic Formulations

The issues surrounding the use of polysorbates within liquid biologic formulations are well known within the industry. What isn’t so well understood are the alternatives to this technology. This webcast will explore an exciting excipient, Kleptose® BioPharma, and its application within biologic formulations as a potential functional alternative to polysorbates.

ENGLISH and CHINESE versions are both available.

English version

webinar

Overview

The issues surrounding the use of polysorbates within liquid biologic formulations are well known within the industry. What isn’t so well understood are the alternatives to this technology. This webcast will explore an exciting excipient, KLEPTOSE® BioPharma, and its application within biologic formulations as a potential functional alternative to polysorbates.

The webcast discussion will:

  • Demonstrate the promise of this excipient in the development of biosimilars.
  • Present data on how polysorbates can be functionally replaced in liquid dosage forms.
  • Provide data-driven insights into the mechanism of action for HP-beta-cyclodextrins in protein formulations.

Key Learning Objectives

  • Understand how cyclodextrins can be used in the formulation of biosimilars, especially those where the reference formulation contains polysorbates.
  • Understand the basic mechanism of action for cyclodextrins within protein formulations.
  • Learn how to tackle a new formulation challenge using cyclodextrins as an excipient tool.

中文版

webinar

罗盖特KLEPTOSE® BIOPHARMA — 生物制剂中表面活性剂的新型替代解决方案

来自罗盖特新加坡研发中心资深科学家 彭韬博士,将为您带来聚山梨酯的替代解决方案,并展示一系列罗盖特新加坡生物制药创新实验室的最新成果,欢迎各生物制药企业(尤其是单克隆抗体类药品企业)的研发/生产/质控人员莅临,和罗盖特一起,探索生物制药开发的更多可能。

市场背景

单克隆抗体药物是通过淋巴细胞杂交瘤技术或基因工程技术制备而得,目前已成为生物制药领域的一个重要方面,单克隆抗体药物作为一种大分子蛋白类药物,其理化性能及结构特点等均与小分子化学药品存在一定的差异。其高特异性、有效性和安全性正发展成为全球新型诊断和治疗药。尤其是治疗性抗体药物,作为一种具有独特优势的生物靶向治疗药物,已成为目前全球药物研发的热点。

热点话题

蛋白质具有天然的不稳定特性,当外部条件变化,例如温度,剪应力,震动,溶剂,和制剂离子强度等的变动,以及蛋白质制剂本身纯度和浓度的变化,都可能会造成蛋白质制剂的性质发生改变。而在所有蛋白质变性降解的问题中,蛋白质聚集的问题尤为普遍和令人头疼。 一个优化的下游制剂方案对维持蛋白质制剂的稳定性和药效性至关重要。 众多药用辅料被应用于下游制剂中,其中就包括非离子型的表面活性剂聚山梨酯(吐温20/80),由于其在保护许多蛋白质中有效,聚山梨酯普遍存在于蛋白质制剂中。事实上,特别是对于单克隆抗体(Mab),超过70%的市售制剂含有聚山梨酯20或聚山梨酯80 (PS20或PS80)。

解决方案

然而,原料形式的和水溶液形式的聚山梨酯均会随时间推移而降解,在实际使用中效果并不令人满意,且降解后的聚山梨酯可能会对蛋白质制剂本身带来影响。作为吐温20/80的替代解决方案,当罗盖特KLEPTOSE® BIOPHARMA被应用于制剂中时,在延缓和阻止蛋白质聚集问题上表现出了优异的性能,为蛋白质稳定提供了新的解决方案。

会议主要议题

  •  羟丙基-ß-环糊精用于生物药制剂方案优越性案例分析;
  •  通过实例了解和证明吐温20/80的替代解决方案;
  •  了解和分析羟丙基-ß-环糊精用于生物类似药制剂的作用机制