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Meeting large-scale HPAPI production needs

机译:满足大规模HPAPI生产需求

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New generation molecules are the focus of much of the research and development efforts of the global pharmaceutical market. The general industry trend has been to steer the development of therapies towards increasingly selective, and therefore increasingly potent, molecules, with the possibility of extending to additional therapeutic areas (oncology in particular). Olon Group, a CDMO which has more than doubled its growth in strategic investments during the last five years, is building capabilities to provide support for pharmaceutical partners throughout all stages of the development process. Target therapies - drugs that are selective and therefore better tolerated by the patient - have an action that targets only the mechanism underlying development of the disease. They are finding increasingly broad application in treating the world's most widespread oncological diseases (primarily breast cancer), but also rheumatic and respiratory diseases and other major therapeutic categories with unmet needs. Improvements in treatment selectivity result in demand for increasingly potent active pharmaceutical ingredients. These ingredients require highly specific technologies, systems and skills to meet the appropriate standard of containment and guarantee there has been no contamination of operators and products. "We have built large-volume containment facilities," says Giorgio Bertolini, VP RD Olon Group, "to support the production of new drug classes, in particular oncology drugs. Despite containing a very small quantity of highly potent active ingredient, these have to be made available to a large number of patients worldwide. This requires large batch sizes of product, so as to allow pharmaceutical companies to guarantee access to therapies for all patients who need it."
机译:新一代分子是全球制药市场大部分研发工作的重点。总的行业趋势是引导疗法的发展,使其具有越来越强的选择性,因此越来越有效,并有可能扩展到其他治疗领域(尤其是肿瘤学)。Olon Group是一家CDMO公司,在过去五年中,其战略投资增长了一倍多,正在建立在开发过程的各个阶段为制药合作伙伴提供支持的能力。靶向治疗 - 具有选择性的药物,因此患者耐受性更好 - 具有仅针对疾病发展机制的作用。它们在治疗世界上最广泛的肿瘤疾病(主要是乳腺癌)以及风湿病和呼吸系统疾病以及其他需求未得到满足的主要治疗类别方面得到了越来越广泛的应用。治疗选择性的提高导致对更有效的活性药物成分的需求越来越大。这些成分需要高度特定的技术、系统和技能,以满足适当的遏制标准,并保证操作人员和产品没有受到污染。“我们已经建立了大量的密闭设施,”奥隆集团研发副总裁Giorgio Bertolini说,“以支持新药物类别的生产,特别是肿瘤药物。尽管含有极少量的高效活性成分,但这些成分必须提供给全世界的大量患者。这需要大批量的产品,以便制药公司能够保证所有需要治疗的患者都能获得治疗。

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    《Cleanroom technology》 |2022年第5期|33-34|共2页
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