A Novel Inexpensive Process for Preparation of Polymeric Microspheres

spheritage专利技术不仅新颖，而且为制造聚合物微球提供了一种廉价、高效的方法。最重要的目标是为三个目标市场确定一系列聚合物和连接技术。确定具体的协议和技术诀窍对于这项工作的成功至关重要。最终，这将导致为每个选定的市场部门大规模生产专业聚合物微球。在生物催化领域，竞争技术的全球市场规模约为250亿美元（Biocombinatorial Approaches for DrugFinding，施普林格Berlin Heidelberg）。国际标准图书编号978-3-540-22092-3)。在全球8000亿美元的商品、特种和精细化学品市场中，有500亿美元已经可以通过生物工艺解决。在未来的10到20年里，生物应用程序的潜在价值将达到2000亿美元（化学与工程新闻，第79卷，第21期）。基于肽的药物已经是药物组合的一个主要部分。前十大肽类药物的年销售额总计超过2000美元，其中排名前五的药物正处于专利保护的后期阶段。多肽最有价值的市场领域是前列腺癌治疗领域，由于这些多肽几乎是由主要制药公司同时开发的，它们都接近专利寿命的终点。Leuprolide（拜耳公司，赛诺菲-安万特和其他公司）在2005年获得专利，已经有5-6家仿制药制造商表现出兴趣。sphereech的创始人兼首席执行官don Wellings博士曾为三家公司就Leuprolide的合成提供咨询，出于保密原因，这三家公司不能透露其名称。亲和层析，用于纯化生物制药是制造成本的最高贡献者。例如，固定化蛋白A（一种能够与各种类型的免疫球蛋白[lg]分子结合的天然蛋白，由各种细菌菌株排泄）用于纯化单克隆抗体。蛋白A培养基在2007年的市场规模估计为4900万美元，2013年的市场规模估计为7000万美元，基于抗体生产的平均年增长率为6%。本应用程序的C部分将介绍更详细的市场研究。sphereech计划在3-4年内在每个市场领域获得显著的市场份额。

The technology patented by SpheriTech and described in this application isnot only novel but provides an inexpensive and efficient means formanufacture of polymeric microspheres.Page 3 of44The most important objective is to identify a range of polymers and linkagetechnologies for the three target markets. Identification of specific protocolsand technical know how is essential for the success of this work. Ultimatelythis will lead to large scale production of specialist polymeric microspheres foreach chosen market sector.In biocatalysis the worldwide market for the competing technology ismeasured in the region of $25 billion (Biocombinatorial Approaches for DrugFinding, Springer Berlin Heidelberg. ISBN 978-3-540-22092-3). $50 billion ofthe $800 billion global commodity, specialty, and fine chemicals markets arereadily addressable by bioprocesses. Another $200 billion has been identifiedas potentially addressable by biological app~oaches in the next 1 0 to 20 years(Chemical & Engineering News, Volume 79, Number 21).Peptide based drugs are already a major section of the pharmaceuticalportfolio. Sales of the top ten peptide based drugs total over $2000mannually and the top five of these are in the late stages of patent protection.The highest value market sector in peptides is in the area of prostate cancertherapy and since these were developed almost concurrently by majorpharmaceutical companies they are all nearing the end of their patent life.Leuprolide (Bayer AG, Sanofi-Aventis and others) came off patent in 2005and already there are 5-6 generic drug manufacturers showing interest. DrDon Wellings, the founder and CEO of SpheriTech has consulted on thesynthesis of Leuprolide for three individual companies that cannot be namedfor reasons of confidentiality.Affinity chromatography, used in the purification of biopharmaceuticals is thehighest contributor to the cost of manufacture. lmmobilised Protein A (anatural protein capable of binding to various classes of immunoglobulin [lg]molecules, excreted by various bacterial strains) for example is used for thepurification of monoclonal antibodies. The market size for Protein A media in2007 was estimated to be $49 million and the market size in 2013 isestimated to be $70 million based on an average annual growth rate of 6% inantibody production.More detailed market research is covered in Part C of this application.SpheriTech plans to obtain a significant market share within each marketsector in 3-4 years.