Uppal Annu, Chakrabarti Ranjan, Chirmule Narendra, Rathore Anurag, Atouf Fouad
US Pharmacopeia India Pvt Ltd, Hyderabad, Telangana India.
SymphonyTech Biologics Private Limited, Pune, Maharashtra India.
J Pharm Innov. 2022;17(4):1555-1562. doi: 10.1007/s12247-021-09596-9. Epub 2021 Nov 26.
The biopharmaceutical industry is evolving with a shift in focus from recombinant proteins and antibodies towards more complex cell and gene therapies. To be competitive globally, biomanufacturers need to focus on aligning with global standards with regard to drug quality, reducing manufacturing failures and delivering drugs to market quickly. Building these capabilities requires a multifaceted approach that includes improvements in operations, quality compliance, and control strategies. To address these needs, the US Pharmacopeia (USP), the Department of Biotechnology (DBT) India, and the Confederation of Indian Industry (CII) held a symposium to discuss the requirements and gaps in the biotechnology and pharmaceutical sectors in India and other developing countries. A panel of experts from academia, manufacturing, and governmental agencies identified several drivers needed for capability building, including a skilled workforce, public-private partnerships, advanced manufacturing technologies, novel biologics, and favorable policies. This article summarizes the recommendations put forward by this panel.
生物制药行业正在不断发展，重点已从重组蛋白和抗体转向更复杂的细胞和基因疗法。为了在全球范围内具有竞争力，生物制造商需要专注于在药品质量方面与全球标准保持一致，减少生产失败，并迅速将药品推向市场。建立这些能力需要采取多方面的方法，包括改进运营、质量合规和控制策略。为满足这些需求，美国药典（USP）、印度生物技术部（DBT）和印度工业联合会（CII）举办了一次研讨会，讨论印度和其他发展中国家生物技术和制药行业的要求与差距。来自学术界、制造业和政府机构的专家小组确定了能力建设所需的几个驱动因素，包括熟练的劳动力、公私合作伙伴关系、先进的制造技术、新型生物制品和有利的政策。本文总结了该专家小组提出的建议。
