CRB’s Niranjan Kulkarni contributes to ISPE’s ATMP Allogeneic Cell Therapy Baseline Guide
Jan 18, 2024
ISPE recently launched an industry guide on ATMP allogeneic cell therapies, which focuses on manufacturing facility development and design. The guidance document pulls from expertise across the industry, including insight from CRB’s very own Niranjan Kulkarni, PhD, Sr. Director of Consulting Services.
We are proud of Dr. Kulkarni for his dedication to advancing the biopharma industry and the health of the patients we serve.
Over 144 pages, the ISPE Guide: ATMPs Allogeneic Cell Therapies covers key aspects of facility layout, design, and development for allogeneic cell therapy facilities. It highlights the unique challenges faced in manufacturing, including small-scale, scale-up limitations, and the need for flexibility. Critical manufacturing areas such as sampling, QC, process, and GMP regulations are well captured in this reference. The document also offers relevance to other ATMPs, covering regulatory compliance, technology transfer, utilities, HVAC, and supply chain considerations. The guide’s framework builds upon the ISPE Guide: Advanced Therapy Medicinal Products – Autologous Cell Therapy, creating a robust and cohesive resource for the industry.
The full document can be accessed here: ISPE Guide: ATMPs Allogeneic Cell Therapies.