Industrial Viral Vector Manufacturing Using Advanced Process Analytical Technologies

细胞和基因疗法为疾病的治愈、治疗或长期管理提供了前所未有的希望。然而，该行业面临的挑战是需要能够持续生产到商业规模的病毒载体，并具有严格的纯度、效力和安全性公差。这项支持先进疗法的合作由牛津生物医药公司（OXB）牵头，包括两家英国中小企业；利用OXB在慢病毒载体开发和制造方面的现有领导地位，满足内部和合作伙伴组织的需求。我们的目标是开发和应用新的先进技术，以进一步发展当前的制造平台，从而提高为临床和商业应用提供高质量载体的能力。该项目具有真正的潜力，可以在缩短临床时间和上市时间方面为患者带来切实的好处，并降低将这些新疗法带给患者的成本和可及性。每个合作伙伴都拥有专有技术和专有知识，将用于开发这种创新的病毒载体制造方法。合作伙伴将寻求在细胞和基因治疗方面获得新的市场机会，从而促进经济增长和增加高技能员工的就业。这个创新项目的可开发成果与当前政府的国家优先事项密切相关，使英国成为制造先进疗法的全球中心。

Cell and gene therapies offer unprecedented promise for the cure, treatment or long term management of disease. However, the challenge facing the industry is the need for viral vectors which can be consistently manufactured to commercial scale with rigorous tolerances for purity, potency and safety. This collaboration to support advanced therapies is led by Oxford BioMedica (OXB) and includes 2 UK SME's; using OXB's existing leadership position in the development and manufacture of lentiviral vectors to meet in-house and partner organisation needs. Our aim is the development and application of novel advanced technologies to further evolve the current manufacturing platform, leading to an increase in the ability to deliver high quality vector for clinical and commercial applications. The project has the real potential to deliver tangible benefits to patients in shortening time-to-clinic and time-to-market as well as to improve the cost and access of bringing these novel therapies to patients. Each partner holds proprietary technology and know-how which will be leveraged to develop this innovative approach to viral vector manufacturing. The partners will look to access new market opportunities in cell and gene therapy resulting in economic growth and increased employment of highly skilled staff. The exploitable outcomes of this innovative project are closely aligned with the current government national priorities to make the UK a global hub for manufacturing advanced therapies.