科瑞思特(Crystec)是一家英国高科技公司,掌握全球最先进的超临界流体结晶产业化平台技术(mSAS®),一种高效、稳定,可放大的药物递送技术,并得到了药监部门的认可。该技术应用面广,适用于小分子化学药和大分子生物药,通过优化各种药物剂型(例如吸入,口服,鼻内,皮下,舌下),增强体内给药效率,提高临床疗效。公司创始人于九十年代中期在全球率先将超临界结晶技术应用于药物结晶和微粒设计领域,并带领团队发明了一系列工艺专利,成为全球公认的该领域领军人。科瑞思特建立了完整的超临界结晶技术(mSAS®)产业化设施和工艺开发能力,包括小试,中试到cGMP生产。同时,该公司根据临床需求及其技术优势,在某些重要领域开发了一系列自主创新产品管线,包括妇女健康,偏头痛,呼吸疾病,感染类等领域。科瑞思特的技术平台得到了中英两国政府的支持,公司先后获得英国科技部资助的高端生产技术链奖,创新部技术创新奖,和中英联合资助的中英牛顿基金奖,以及欧洲CPHI药物制剂和合同服务外包卓越奖。
科瑞思特(Crystec)与全球许多医药企业建立了合作,为他们提供优化的制剂解决方案,开发差异化产品。利用mSAS®平台技术的独特能力,开发更高质量(例如,提高药物稳定性和产品批次间一致性),更直接的给药靶点(例如,准确的局部给药),和更方便的使用(例如,吸入给药代替针剂),以提高临床疗效(例如,提高生物利用度和快速起效),造福患者。
CrystecPharma is a crystal and particle engineering company applying proprietary modified supercritical fluid (SCF) technologies to improve the performance of medicines. The technology enables drug molecules to be crystallised in new forms and novel particles to be manufactured in ways that greatly enhance their therapeutic performance. Crystec has an enabling platform which can be applied to small and large molecules, to optimise a range of medicine dosage forms (e.g. oral, inhaled, intranasal, subcutaneous, sublingual).
Crystec works with the global pharmaceutical and health care industry to solve drug particle formation, formulation and process challenges. They are also developing their own innovative therapies in important areas of unmet clinical need, including women’s health, urology and treating respiratory disease. Crystec’s proprietary ‘mSAS®’ (modified Supercritical Anti-Solvent) drug delivery technology is enabled by a highly efficient, stable and fully scalable manufacturing process and is approved by regulatory authorities. This award winning mSAS® platform creates unique opportunities to improve medicines in ways that can transform the quality of life for many patients.
The Crystec team is multi-disciplinary with extensive experience in pharmaceutical development. The team have pioneered the application of SCF to pharmaceuticals and consists of acknowledged leaders in relevant fields of science, drug delivery, engineering, scale-up, manufacturing and medicine, underpinned by senior-level pharmaceutical industry and licensing experience.
ProImmune为临床前和临床免疫学研究提供独特的解决方案, 包括全面集成的抗原表征平台,以及使用最先进的 ELISpot 和流式细胞术技术跟踪抗原特异性免疫反应的产品和服务。Prolmmune在免疫系统领域成为领先者是因为他可以识别潜在表位(在免疫系统中可以识别的物质部分称为表位)并监测免疫系统对他们的反应。
ProImmune offer unique solutions for preclinical and clinical immunology research, including a comprehensive and integrated antigen characterization platform, and products and services for tracking antigen-specific immune responses with state-of-the-art ELISpot and flow cytometry techniques. Portions of substances that the immune system can recognise are called epitopes, and identifying potential epitopes and monitoring the immune response to them is where ProImmune has become a world leader.
Actigen正在开发的GNR-055是一种用于治疗粘多糖累积症II型(MPS II)的新型脑穿透性依杜醛酸-2-硫酸酯酶替代疗法。由于MPS II的病程是可变的,并且随着儿童的逐渐发育而变得复杂,出生时看起来正常的儿童通常在2-4岁时开始表现出身体症状,包括呼吸和心脏功能障碍、认知缺陷、行为缺陷、神经系统受累和各种其他症状。GNR-055是专门设计的,通过抗体片段中的重组融合蛋白来解决体细胞和中枢神经系统缺陷,抗体片段可用于治疗MPS II。该抗体片段识别人胰岛素受体α-亚基的细胞外表位,并可通过血脑屏障运输。
Actigen, a privately funded UK company, is currently developing GNR-055, A novel brain-penetrating iduronate-2-sulfatase enzyme replacement therapy for treatment of MPS II. Because the course of MPS II is variable and complicated by the gradual development of the child, children who appear normal at birth typically begin to exhibit physical symptoms, including respiratory and cardiac dysfunction, cognitive deficits, behavioral deficits, neurological involvement, and a variety of other symptoms by the age of 2-4 years.GNR-055 is specifically designed to address both the somatic and CNS deficits through a recombinant fusion protein in the antibody fragment, an antibody fragment that can be used to treat MPS II. recombinant fusion protein, the antibody fragment recognizes the extracellular epitope of the α-subunit of the human insulin receptor and can be transported across the blood-brain barrier.
Woodley BioReg成立于2000年,致力于帮助制药、生物制药/生物仿制药、医疗保健和医疗器械公司开发和生产高质量的产品,为全球患者提供有效和安全的产品。Woodley BioReg与世界各地的客户合作,从世界上最大的制药公司到新兴的生物技术公司。我们利用在CMC、法规事务、GMP/QA和临床等各个方面的实践经验来加速药品的开发和批准。
Woodley BioReg利用其完善的cGMP认证流程和具有商业竞争力的监管批准策略,帮助其客户在全球范围内成功注册药物,包括在英国和欧盟。在自己的MHRA GMP许可下,Woodley BioReg使其国际客户能够将其产品出口到英国和欧盟进行分销。
Founded in 2000, Woodley BioReg is dedicated to helping pharmaceutical, biopharmaceutical /biosimilar, healthcare and medical device companies develop and manufacture high quality products that are effective and safe for patients worldwide. Woodley BioReg works with a wide range of clients around the world, from the world's largest pharmaceutical companies to start-up biotechnology organisations. We use our hands-on experience in all aspects of CMC, Regulatory Affairs, GMP/QA and Clinical to accelerate the development and approval of medicinal products.
Woodley BioReg helps its clients to successfully register drugs worldwide including in the UK and EU using its well-established process for cGMP certification and commercially competitive regulatory approval strategies. Under its own MHRA GMP licence, Woodley BioReg enables its international clients to export their products to the UK and EU for distribution.