Sartorius Stedim Biotech GmbH, Göttingen, Germany.
Adv Biochem Eng Biotechnol. 2014;138:207-37. doi: 10.1007/10_2013_220.
: As the age of the blockbuster drug recedes, the business model for the biopharmaceutical industry is evolving at an ever-increasing pace. The personalization of medicine, the emergence of biosimilars and biobetters, and the need to provide vaccines globally are just some of the factors forcing biomanufacturers to rethink how future manufacturing capability is implemented. One thing is clear: the traditional manufacturing strategy of constructing large-scale, purpose-built, capital-intensive facilities will no longer meet the industry's emerging production and economic requirements. Therefore, the authors of this chapter describe the new approach for designing and implementing flexible production processes for monoclonal antibodies and focus on the points to consider as well as the lessons learned from past experience in engineering such systems. A conceptual integrated design is presented that can be used as a blueprint for next-generation biomanufacturing facilities. In addition, this chapter discusses the benefits of the new approach with respect to flexibility, cost, and schedule. The concept presented here can be applied to other biopharmaceutical manufacturing processes and facilities, including-but not limited to-vaccine manufacturing, multiproduct and/or multiprocess capability, clinical manufacturing, and so on.
随着重磅药物时代的远去，生物制药行业的商业模式正以前所未有的速度发展和演变。药物的个体化、生物类似药和生物改良药的出现，以及在全球范围内提供疫苗的需求，这些只是迫使生物制造商重新思考如何实施未来制造能力的部分因素。有一点很清楚：大规模、专用、资本密集型设施的传统制造策略将不再满足行业新兴的生产和经济需求。因此，本章的作者描述了用于设计和实施单克隆抗体的灵活生产工艺的新方法，并重点介绍了在工程此类系统方面的注意事项和经验教训。提出了一个概念性的综合设计，可以作为下一代生物制造设施的蓝图。此外，本章还讨论了这种新方法在灵活性、成本和进度方面的优势。这里提出的概念可以应用于其他生物制药制造工艺和设施，包括但不限于疫苗制造、多产品和/或多工艺能力、临床制造等。
