Manufacturing Process for Albumin-ICG Solder & Denatured Albumin Scaffold

描述(申请人提供)：长期目标：激光组织焊接公司专注于创新的无缝合激光组织焊接领域的研究和产品开发，使用可生物降解和生物兼容的生物材料，在涉及创伤、癌症和移植的固体内脏器官(如肝、脾和肾脏)表面连接、修复和止血，并在存在稀释凝血疾病或治疗性抗凝的情况下进行移植。具体目标：为激光组织焊接(LTW)所需的两种生物材料‘白蛋白-吲哚青氨酸焊料’(AIS)和‘变性白蛋白支架’(DAS)开发新的制造工艺。该项目将在原型基础上解决制造过程及其验证、设计控制、生物兼容性、伽马辐射灭菌验证、包装强度和完整性、用于监管目的的加速老化等问题。研究设计和方法：开发和验证AIS和DAS生物材料的制造工艺，工艺可以放大和自动化。(每种产品约400个样品)潜在的技术创新：这项技术的成功因素是开发了一种由生物相容的变性人血清白蛋白制成的可激光焊接的卓越支撑结构。预期结果：在成功制造和验证原型后，我们将扩大制造流程，使其符合cGMP规范，并开始监管审批程序，以开始人体临床试验。潜在的商业应用：肝、脾和肾的创伤修复(200,000例/年)；肝肿瘤：原发性肝癌(22,000例/年)和转移性肝肿瘤(65,000例/年)；分离式肝移植(17,300名患者在等待名单上)；良性病变的肾部分切除术(500例/年)；尿路修复：对于尿道下裂、尿路狭窄、尿路憩室和尿瘘(每年600次)和皮肤修复(目前使用缝线的所有外科手术)相关：1)LTW将挽救生命，因为它能够快速修复(分钟)并控制脾、肝和肾等器官表面的出血，同时最大限度地减少热损伤。2)在创伤病例中帮助保存和挽救肝、脾、肾等器官。3)通过减少输血来保护血液。4)可用于择期肝、肾手术。

DESCRIPTION (provided by applicant): Long term objectives: Laser Tissue Welding, Inc. focuses its research and product development in areas of innovative sutureless laser tissue welding using biodegradable and biocompatible biomaterials to join, repair and create hemostasis on surfaces of solid visceral organs such as the liver, spleen and kidney involved in trauma, cancer, and transplantation in the presence of dilutional coagulopathies or therapeutic anticoagulation. Specific Aims: Develop new manufacturing processes for 'Albumin-lndocyanine Solder' (AIS) and 'Denatured Albumin Scaffold' (DAS) two biomaterials required for laser tissue welding (LTW). This project will address the manufacturing process and its validation, design control, biocompatibility, gamma radiation sterilization validation, package strength and integrity, accelerated aging for regulatory purposes on a prototype basis. Research design and Methods: Develop and validate the manufacturing process for AIS and DAS biomaterials with processes that can be scaled up and automated. (Approximately 400 samples per product) Potential Technology innovation: The success factor for this technology is the development of a superior support structure made of biocompatible denatured human albumin that can be laser soldered. Anticipated outcomes: After successful prototype manufacturing and validation, we will scale up the manufacturing process to cGMP specifications and begin the regulatory approval process to begin human clinical trials. Potential commercial applications: These are trauma repair of the liver, spleen and kidney (200,000 case/year); liver tumors: primary hepatomas (22,000/yr), and rietastatic liver tumors (65,000/yr); split liver transplant (17,300 patients on the waiting list); partial nephrectomy for benign lesions (500/year); Urethral repair: for hypospadias, urethral stricture, urethral diverticulum, and urethral fistulae (600/yr) and skin approximation (all surgical procedures that currently use sutures) Relevance: 1) LTW will save lives due to its ability to quickly repair (minutes) and control hemorrhage from the surfaces of organs such as the spleen, liver, and kidney with minimal thermal injury. 2) Helps preserves and salvages organs such as liver, spleen, and kidney in trauma cases. 3) Blood conservation by reducing transfusion requirements. 4) Can be used laparoscopically for elective surgeries on liver and kidney.