Abstract：
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.
摘要：
政府和生物制药组织积极利用迅速的沟通能力，决策模型，以及制造COVID-19疫苗的全球战略在12个月内发生。这是一项不寻常的努力，不能转移到正常时间。然而,这种对单一疫苗的关注也导致其他治疗方法和药物开发被搁置。社会期望制药行业提供不间断的药物供应。然而,人们经常忽略这些化合物的制造有多复杂，需要什么物流，更不用说开发新药物所需的时间了。总的主题，因此,是患者的获取，以及我们如何帮助确保获取并将其扩展到低收入和中等收入国家。尽管不断努力向所有患者人群提供药物，绝不能以牺牲患者安全为代价。生物制药制造的大部分成本用于药物发现，过程开发,和临床研究。基础设施成本很难量化，因为它们通常取决于绿地设施还是现有的、折旧设施用于或适用于新产品。为了加速流程开发，平台流程和先验知识的概念越来越重要。虽然更多传统的蛋白质疗法继续主导该领域，我们也正在经历其他治疗形式的令人兴奋的出现和演变(bispecifics，四价单克隆抗体，抗体-药物缀合物，酶，肽，等。）为患者提供独特的治疗选择。蛋白质形态仍然占主导地位，但是正在开发新的模式，可以从先进的治疗方法，如细胞和基因疗法中学习。行业必须制定基于模型的工艺开发策略，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，专注于以牺牲其他方式/疾病目标为代价的疫苗交付，并对职业和个人生活（工作与生活平衡）产生了影响。将开发时间从10年减少到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。
