Biopharmaceutical Industry Capability Building in India: Report from a Symposium.

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.

Building trust in the quality of vaccines.

To date, several COVID-19 vaccines have been authorized for the voluntary immunization of adults. The quick availability of multiple vaccines is a good strategy to achieve herd immunity during a pandemic. However, the fast-track development of vaccines during this pandemic has raised concerns regarding the quality, safety, and effectiveness of vaccines. In response, USP organized a roundtable to discuss challenges and to solicit input on ways to build trust in vaccines. Key discussion points included manufacturing capacity, availability of a skilled workforce, and investment in new technologies that would enable the safety and quality of vaccine products. There was also a consensus that a rigorous and transparent clinical trial design is essential for understanding the safety and effectiveness of vaccines.

Recommendations for Enhancing Quality and Capability of Indian Biopharmaceutical Industry: Summary of a Workshop.

The biopharmaceutical industry is undergoing an evolutionary phase with the rise of advanced manufacturing technologies. The regulatory and customer requirements are shifting towards the development of personalized or targeted medicines. With this changing landscape, industry must evaluate the relevance of quality management systems. Over the past two decades, Indian companies have played a significant role in generating access and reducing costs of medicines. The quality management systems that enable the development and manufacturing of biopharmaceuticals require companies to adapt to regulatory requirements of process development, clinical trials, production, and life cycle management. To better understand the status and potential opportunities to enhance the quality management systems of manufacturing biopharmaceuticals, a workshop was organized by United States Pharmacopeia (USP) and Association of Biotechnology Led Enterprises (ABLE). This paper summarizes the recommendations by the panel and participants of the workshop to industry stakeholders, governance bodies, and policymakers. Following points were proposed to strengthen the culture of quality processes in Indian biopharmaceutical industry: i) Inculcating a culture of quality; ii) Effective training programs on quality processes; iii) Focus on quality beyond compliance; iv) Focus on automation and digitization. v) Enhance processes for pharmacovigilance and product life cycle management. vi) Understanding global regulatory processes.