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Optimization of Protein Therapeutic Formulations

蛋白质治疗配方的优化

基本信息

批准号：
7915062
负责人：
Lawrence J Delucas
金额：
$ 21.5万
依托单位：
SOLUBLE THERAPEUTICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-06-15 至 2012-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7915062
关键词：
Academia Address Agreement Biological Neural Networks Biological Products Biotechnology Buffers Businesses Chromatography Chronic Disease Client Communities Computer Simulation Contracts Data Development Drug Formulations Excipients Foundations Future Government Industry Institution Ionic Strengths Lead Legal patent Letters Licensing Marketing Measures Membrane Proteins Miniaturization Monitor Monoclonal Antibodies Osteoporosis Patients Pharmaceutical Preparations Pharmacologic Substance Phase Physiologic calcification Process Proteins Publishing Reporting Research Research Contracts Research Personnel Resources Sales Services Sodium Chloride Solubility Solutions System Techniques Technology Temperature Therapeutic Time Training Tumor necrosis factor receptor 11b Update Vaccines Validation aqueous base cost design drug development drug discovery enthalpy high throughput technology improved light scattering new technology novel novel strategies novel vaccines programs protein expression public health relevance therapeutic protein vaccine candidate

项目摘要

DESCRIPTION (provided by applicant): This proposal involves the development and validation of a novel approach to improve and accelerate the discovery of biopharmaceuticals (i.e. vaccines, monoclonal antibodies and other therapeutic proteins). Biopharmaceuticals are used to treat a variety of infectious and chronic diseases. The proposed research is intended to establish a new paradigm for rapidly improving the solubility and physical stability of biopharmaceuticals. The paradigm will be evaluated using one or more vaccine candidates obtained from a pharmaceutical company as well as the protein osteoprotegerin (OPG), which is involved in bone mineralization and osteoporosis. According to the latest Data-Monitor Report published in June, 2008, protein therapeutics represents the second largest segment in pharmaceutical drug discovery. Since 2000, more than 25% of all new drugs approved have been biopharmaceuticals but there development is a time-consuming and costly endeavor. The development of biopharmaceuticals requires that the protein therapeutic is highly soluble since a substantial amount of the protein must be injected in patients via a small volume of solution. Pharmaceutical and biotechnology companies devote significant time and resources developing suitable formulations that allow the desired protein to be concentrated to high levels without inducing instability in the protein. This process of formulation development is often the major bottleneck in the protein therapeutic discovery process. This proposal involves the use of existing technologies and a novel high-throughput technology to provide information regarding a protein's solubility and stability in different solution conditions (formulations). The information will be used to train an artificial neural network program to predict totally new solution conditions that provide improved protein solubility and stability. If successful, this capability will accelerate and improve the ability to develop clinically useful formulations for biopharmaceuticals being developed by pharmaceutical, biotechnology, government and academic communities. It will also benefit any protein expression research organization (expressing aqueous or membrane proteins) that desires improved solubility and physical stability of expressed protein. It will reduce the cost and time required to develop new vaccines, monoclonal antibodies and other protein therapeutics. Soluble Therapeutics, LLC intends to support biopharmaceutical research as a CRO by establishing collaborative relationships with researchers from industry, academia and the government. It is expected that as industrial partners realize the advantages the company's novel technology it will lead to non-exclusive licenses and strategic partnerships. PUBLIC HEALTH RELEVANCE: This proposal involves the development and validation of a novel approach to improve and accelerate the discovery of biopharmaceuticals (i.e. vaccines, monoclonal antibodies and other therapeutic proteins). Biopharmaceuticals are used to treat a variety of infectious and chronic diseases. The proposed research is intended to establish a new paradigm for rapidly improving the solubility and physical stability of biopharmaceuticals. The paradigm will be evaluated using one or more vaccine candidates obtained from a pharmaceutical company as well as the protein osteoprotegerin (OPG), which is involved in bone mineralization and osteoporosis. According to the latest Data-Monitor Report published in June, 2008, protein therapeutics represents the second largest segment in pharmaceutical drug discovery. Since 2000, more than 25% of all new drugs approved have been biopharmaceuticals but there development is a time-consuming and costly endeavor. The development of biopharmaceuticals requires that the protein therapeutic is highly soluble since a substantial amount of the protein must be injected in patients via a small volume of solution. Pharmaceutical and biotechnology companies devote significant time and resources developing suitable formulations that allow the desired protein to be concentrated to high levels without inducing instability in the protein. This process of formulation development is often the major bottleneck in the protein therapeutic discovery process. This proposal involves the use of existing technologies and a novel high-throughput technology to provide information regarding a protein's solubility and stability in different solution conditions (formulations). If successful, this capability will accelerate and improve the ability to develop clinically useful formulations for biopharmaceuticals being developed by pharmaceutical, biotechnology, government and academic communities. Soluble Therapeutics, LLC intends to support biopharmaceutical research as via contract research by establishing collaborative relationships with researchers from industry, academia and the government. It is expected that as industrial partners realize the advantages the company's novel technology it will lead to non-exclusive licenses and strategic partnerships.

描述（由申请人提供）：该提案涉及开发和验证一种新方法，以改善和加速生物药物（即疫苗、单克隆抗体和其他治疗性蛋白质）的发现。生物制药用于治疗各种传染病和慢性疾病。该研究旨在建立一种新的范式，以快速提高生物药物的溶解性和物理稳定性。将使用从制药公司获得的一种或多种候选疫苗以及参与骨矿化和骨质疏松症的蛋白质骨保护素（OPG）对该范例进行评价。根据2008年6月发布的最新数据监测报告，蛋白质治疗是药物发现的第二大部分。自2000年以来，超过25%的新药批准已被生物制药，但有开发是一个耗时和昂贵的奋进。生物制药的发展要求蛋白质治疗剂是高度可溶的，因为大量的蛋白质必须通过小体积的溶液注射到患者体内。制药和生物技术公司投入大量的时间和资源开发合适的制剂，使所需的蛋白质浓缩到高水平，而不会引起蛋白质的不稳定性。这种制剂开发过程通常是蛋白质治疗发现过程中的主要瓶颈。该提案涉及使用现有技术和新的高通量技术，以提供有关蛋白质在不同溶液条件（制剂）下的溶解度和稳定性的信息。这些信息将用于训练人工神经网络程序，以预测提供改善蛋白质溶解度和稳定性的全新溶液条件。如果成功，这一能力将加快和提高为制药、生物技术、政府和学术界正在开发的生物药物开发临床有用配方的能力。它也将有益于任何蛋白质表达研究组织（表达水性或膜蛋白），其期望表达的蛋白质的改善的溶解性和物理稳定性。它将减少开发新疫苗、单克隆抗体和其他蛋白质治疗剂所需的成本和时间。Soluble Therapeutics，LLC打算通过与工业界、学术界和政府的研究人员建立合作关系，作为CRO支持生物制药研究。预计随着工业合作伙伴意识到该公司新技术的优势，将导致非独家许可和战略合作伙伴关系。公共卫生相关性：该提案涉及开发和验证一种新方法，以改善和加速生物药物（即疫苗，单克隆抗体和其他治疗性蛋白质）的发现。生物制药用于治疗各种传染病和慢性疾病。该研究旨在建立一种新的范式，以快速提高生物药物的溶解性和物理稳定性。将使用从制药公司获得的一种或多种候选疫苗以及参与骨矿化和骨质疏松症的蛋白质骨保护素（OPG）对该范例进行评价。根据2008年6月发布的最新数据监测报告，蛋白质治疗是药物发现的第二大部分。自2000年以来，超过25%的新药批准已被生物制药，但有开发是一个耗时和昂贵的奋进。生物制药的发展要求蛋白质治疗剂是高度可溶的，因为大量的蛋白质必须通过小体积的溶液注射到患者体内。制药和生物技术公司投入大量的时间和资源开发合适的制剂，使所需的蛋白质浓缩到高水平，而不会引起蛋白质的不稳定性。这种制剂开发过程通常是蛋白质治疗发现过程中的主要瓶颈。该提案涉及使用现有技术和新的高通量技术，以提供有关蛋白质在不同溶液条件（制剂）下的溶解度和稳定性的信息。如果成功，这一能力将加快和提高为制药、生物技术、政府和学术界正在开发的生物药物开发临床有用配方的能力。Soluble Therapeutics，LLC打算通过与工业界、学术界和政府的研究人员建立合作关系，通过合同研究支持生物制药研究。预计随着工业合作伙伴意识到该公司新技术的优势，将导致非独家许可和战略合作伙伴关系。