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Kulkarni featured in Pharmaceutical Engineering

Nov 28, 2023

Niranjan Kulkarni, PhD, Sr. Director of Consulting Services, goes in-depth on the challenges and complexities of supply chains for ATMPs in the recent Pharma Engineering article, “Delivering curative therapies: Autologous vs. allogeneic supply chains.”

These new therapies host a new set of challenges for the industry, especially when it comes to their supply chains. The supply chain costs for ATMPs account for nearly 30% of the total treatment cost. Additional challenges include scale-up and scale-out issues, timely deliveries, and overall cost management. The article emphasizes the critical need for best practices in sample tracking, packaging, storage, regulatory compliance, and efficient communication among clinics, manufacturers, and suppliers.

Beyond the challenges of the autologous vein-to-vein supply chain, Kulkarni and his co-author, Pinar Cicalese, PhD, also outline key similarities between autologous and allogeneic therapy supply chains. They stress the importance of effective planning, risk assessment, and rightsizing resources to manage uncertainties in manufacturing lead times.

The unique and complex nature of ATMP supply chains underscores the need for early and comprehensive supply chain strategies to deliver the curative potential of these therapies to patients.

Read the full article: Delivering Curative Therapies: Autologous Vs. Allogeneic Supply Chains.