Scholarlink

<p>A shift towards the subcutaneous (S.C.) delivery of protein therapeutics is enabling patient-centric at-home self-administration. To circumvent the volume constraints of the S.C. route of delivery, protein therapeutics are required to achieve ever higher concentrations to administer doses beyond 1&#xa0;g. Aqueous technologies rarely concentrate above 175&#xa0;mg/mL and endure syringability and stability complications. Elektrofi’s novel non-aqueous microparticle suspensions enable such ultra-high concentration delivery of protein therapeutics subcutaneously. In this work, we demonstrate the bioequivalence of high-concentration suspensions compared to their aqueous counterparts in a rodent model. The 500&#xa0;mg/mL concentration iteration of the injection was injectable in 20&#xa0;s with forces below 20&#xa0;N. We also demonstrate comparable subcutaneous clearance of the suspension test articles to the aqueous comparator. To the best of our knowledge, this work is the first to report comparable efficacy and immunogenicity of microparticle suspensions to the aqueous comparator formulation. The model commercially available reagents serve as a glimpse into the performance of the Elektrofi technology which is in the process of advancing into the clinic with a multitude of biopharma partnerships.</p> Graphical Abstract <p></p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

S.C. delivery of ultra-high concentration (up to 500 mg/mL) protein microparticle suspensions: pharmacokinetics, efficacy, biodistribution, and immunogenicity

  • 期刊论文

  • 发表日期：

    2025年5月2日

查看全文
  • Sadiqua Shadbar,
  • Lisa Liu,
  • Yi Tang,
  • Farah Kabir,
  • Shankul Vartak,
  • Zishu Gui,
  • Margaret Huck,
  • Eric Weinstein,
  • Moin Khwaja,
  • Aniket Dehadrai,
  • Tyler Carter,
  • James Ivey,
  • Chaitanya Sudrik,
  • Paul Brown,
  • Lyndon Charles,
  • Daniel Dadon

摘要

A shift towards the subcutaneous (S.C.) delivery of protein therapeutics is enabling patient-centric at-home self-administration. To circumvent the volume constraints of the S.C. route of delivery, protein therapeutics are required to achieve ever higher concentrations to administer doses beyond 1 g. Aqueous technologies rarely concentrate above 175 mg/mL and endure syringability and stability complications. Elektrofi’s novel non-aqueous microparticle suspensions enable such ultra-high concentration delivery of protein therapeutics subcutaneously. In this work, we demonstrate the bioequivalence of high-concentration suspensions compared to their aqueous counterparts in a rodent model. The 500 mg/mL concentration iteration of the injection was injectable in 20 s with forces below 20 N. We also demonstrate comparable subcutaneous clearance of the suspension test articles to the aqueous comparator. To the best of our knowledge, this work is the first to report comparable efficacy and immunogenicity of microparticle suspensions to the aqueous comparator formulation. The model commercially available reagents serve as a glimpse into the performance of the Elektrofi technology which is in the process of advancing into the clinic with a multitude of biopharma partnerships.

Graphical Abstract