MVT-100 Manufacturing and Commercialization.

MVT-100 制造和商业化。

基本信息

批准号：
10596070
负责人：
Wyatt Daniel Unger
金额：
$ 20.61万
依托单位：
MICROVASCULAR THERAPEUTICS, LLC
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-08-17 至 2024-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10596070
关键词：
Acceleration Affect Agreement Albumins Back Pain Blood Vessels COVID-19 Capital Charge Clinical Research Contracts Contrast Media Definity Development Dose Echocardiography Electrostatics Ensure Experimental Designs Funding Goals Grant Growth Guidelines Healthcare Image Infusion procedures Label Legal patent Market Research Marketing Methods Microbubbles Microbubbles Ultrasound Contrast Medium National Heart, Lung, and Blood Institute Optison Outcome Parents Pathway interactions Patients Performance Pharmacologic Substance Phase Policies Probability Procedures Production Publications Radiology Specialty Refrigeration Reporting Sales Site Small Business Innovation Research Grant Statistical Data Interpretation Sulfur Hexafluoride System Temperature Therapeutic Ultrasonography Vial device Vision Visualization Water commercialization commercialization readiness data submission design foot improved industrial production manufacture manufacturing capabilities manufacturing process manufacturing scale-up molecular imaging pandemic disease primary endpoint programs quality assurance scale up side effect theranostics ultrasound

项目摘要

PROJECT SUMMARY / ABSTRACT This Commercialization Readiness Program, CRP, (SB1) proposal is directed towards the commercialization of the MVT-100 product as funded by the parent SBIR Phase II grant (NHLBI Phase II SBIR, R44HL137447-01). This CRP will fund finalization of the Quality system to support commercialization and scale-up manufacturing suitable for initial product launch as well as finalization of regulatory strategy to yield commercially viable label claims for MVT-100. This specific proposal is directed towards development of Microvascular Therapeutics’ new, patented, improved, electrostatically neutral, MB USCA, MVT-100, which will firstly be developed for echocardiography via the accelerated 505(b)(2) pathway for development as designated by the FDA. Definity® is an anionic MB (net negative charge) and requires refrigerated storage while MVT-100 is designed for room temperature storage. Our goals are to develop and fully implement a Quality System with upscale manufacturing of our product that will be approved for echocardiography, subsequently developed for radiology ultrasound imaging, and as a platform for therapeutic/theranostic applications. Thus, the Specific Aims are as follows: 1) To finalize and implement a Quality System Control. The goal is to have a Quality System Control in place and ready for full upscale manufacturing of MVT-100. 2) To develop and optimize industrial production methods necessary to ensure consistent and controlled scale-up GMP manufacturing of MVT-100. Milestones are to obtain consistent and controlled scale-up manufacturing processes. And finally, 3) To finalize our regulatory strategy and obtain technical assistance for market research. We will obtain a defined regulatory strategy with a ready-to-launch vision for MVT-100. Successful completion of the proposed aims and subsequent pivotal study will result in a new, room temperature stable MB for echocardiography yielding not only an improved product for echocardiography with less bioeffects but also a platform for development of radiology, molecular imaging and theranostic products. After MVT-100 is approved for echocardiography, and with commercial scale manufacturing in place, our plan is to raise additional capital to build a sales force and launch the product.

项目概要/摘要该商业化准备计划（CRP）（SB1）提案旨在商业化 MVT-100 产品由母公司 SBIR 第二阶段拨款（NHLBI 第二阶段 SBIR，R44HL137447-01）资助。该 CRP 将资助质量体系的最终确定，以支持商业化和扩大生产规模适用于初始产品发布以及监管策略的最终确定，以产生商业上可行的标签 MVT-100 的索赔。该具体提案旨在开发微血管治疗学的新型、专利、改进、静电中性，MB USCA，MVT-100，将首先通过 FDA 指定的加速 505(b)(2) 开发途径 Definity® 是一种阴离子 MB（净值）。负电荷）并且需要冷藏储存，而 MVT-100 设计用于室温储存。我们的目标是开发并全面实施质量体系，对我们的产品进行高档制造，将被批准用于超声心动图检查，随后开发用于放射超声成像，并作为治疗/治疗诊断应用平台。因此，具体目标如下： 1) 最终确定并实施质量体系控制目标是：拥有适当的质量体系控制并为 MVT-100 的全面升级做好准备 2) 开发和开发。优化必要的工业生产方法，以确保一致且受控的 GMP 规模扩大 MVT-100 的生产里程碑是获得一致且受控的放大生产。最后，3) 确定我们的监管策略并获得市场研究的技术援助。我们将获得明确的监管策略以及 MVT-100 即将推出的愿景。成功完成拟议目标和随后的关键研究将产生新的室温用于超声心动图的稳定 MB 不仅是一种改进的超声心动图产品，且生物效应更小也是继MVT-100之后放射学、分子成像和治疗诊断产品的开发平台。批准用于超声心动图检查，并且随着商业规模生产的到位，我们的计划是筹集额外的资金建立销售队伍和推出产品的资金。