MVT-100 Manufacturing and Commercialization.

MVT-100 制造和商业化。

• 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
• 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

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.

项目摘要/摘要