Governments and biopharmaceutical organizations aggressively leveraged expeditious communication capabilities, decision models, and global strategies to make a COVID‐19 vaccine happen within a period of 12 months. This was an unusual effort and cannot be transferred to normal times. However, this focus on a single vaccine has also led to other treatments and drug developments being sidelined. Society expects the pharmaceutical industry to provide an uninterrupted supply of medicines. However, it is often overlooked how complex the manufacture of these compounds is and what logistics are required, not to mention the time needed to develop new drugs. The overarching theme, therefore, is patient access and how we can help ensure access and extend it to low‐ and middle‐income countries. Despite unceasing efforts to make medications available to all patient populations, this must never be done at the expense of patient safety. A major fraction of the costs in biopharmaceutical manufacturing are for drug discovery, process development, and clinical studies. Infrastructure costs are very difficult to quantify because they often depend on whether a greenfield facility or an existing, depreciated facility is used or adapted for a new product. To accelerate process development concepts of platform process and prior knowledge are increasingly leveraged. While more traditional protein therapeutics continue to dominate the field, we are also experiencing the exciting emergence and evolution of other therapeutic formats (bispecifics, tetravalent mAbs, antibody‐drug conjugates, enzymes, peptides, etc.) that offer unique treatment options for patients. Protein modalities are still dominant, but new modalities are being developed that can be learned from including advanced therapeutics‐like cell and gene therapies. The industry must develop a model‐based strategy for process development and technologies such as continuous integrated biomanufacturing must be adopted. The overall conclusion is that the pandemic pace was unsustainable, focused on vaccine delivery at the expense of other modalities/disease targets, and had implications for professional and personal life (work‐life balance). Routinely reducing development time from 10 years to 1 year is nearly impossible to achieve. Environmental aspects of sustainable downstream processing are also described.

中文翻译：

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生物制品下游加工现状及未来发展


各国政府和生物制药组织积极利用快速沟通能力、决策模型和全球战略，在 12 个月内研制出 COVID-19 疫苗。这是一次不寻常的努力，无法转移到正常时期。然而，这种对单一疫苗的关注也导致其他治疗和药物开发被搁置。社会期望制药业能够不间断地提供药品。然而，人们常常忽视这些化合物的制造有多复杂以及需要什么物流，更不用说开发新药所需的时间了。因此，首要主题是患者的可及性以及我们如何帮助确保可及性并将其扩展到低收入和中等收入国家。尽管我们不断努力向所有患者群体提供药物，但绝不能以牺牲患者安全为代价。生物制药制造成本的主要部分用于药物发现、工艺开发和临床研究。基础设施成本很难量化，因为它们通常取决于是否使用新建设施或现有的折旧设施或针对新产品进行改造。为了加速流程开发，平台流程的概念和先验知识被越来越多地利用。虽然更传统的蛋白质疗法继续主导该领域，但我们也正在经历其他治疗形式（双特异性、四价单克隆抗体、抗体药物偶联物、酶、肽等）的令人兴奋的出现和发展，这些形式为患者提供了独特的治疗选择。 蛋白质疗法仍然占主导地位，但正在开发新的疗法，可以从先进的疗法（如细胞和基因疗法）中学习。该行业必须制定基于模型的工艺开发策略，并且必须采用连续集成生物制造等技术。总体结论是，大流行的速度是不可持续的，重点是疫苗接种而牺牲了其他方式/疾病目标，并对职业和个人生活（工作与生活平衡）产生了影响。常规地将开发时间从 10 年缩短到 1 年几乎是不可能实现的。还描述了可持续下游加工的环境方面。