Sharing his views with the audience, Prabhaharan Sankaran, Technical Account Specialist, West Pharmaceutical Services, India, talked about the evolving product and patient needs that drive industry trend. He notified that year on year, the number of biologics and cell gene therapy are increasing around the globe. He also mentioned that by 2025, about 55 per cent of the top 100 molecules around the globe will be based on biologics.
According to him, the things required for the growth of the market are patient safety and compliance, increase in home care and self administration, increasingly stringent regulations and quality standards. Whereas, the challenges are drug-closure compatibility, drive to quality, design excellence, risk mitigation, ease of use, product life-cycle management, particulate control and yield maximisation. He further told that FDA encourages risk-based approaches and adoption of QbD principle during the drug development and manufacturing.
He also made comparisons between the traditional (conventional) and QbD (ideal) processes of product development. Besides, he talked about the various applications of QbD in product development that include mitigating risk, optimised functional profile, high visual quality and low product-to-product variation, among others.
He concluded that QbD principle has been adopted to develop NovaPure closures which focusses on understanding changing regulatory requirements, customer needs and relevant guidances and principles in development.
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