Application of PAT for Process Understanding and Control Strategy during Development and Manufacturing of Oligonucleotides

Jale Muslehiddinoglu, PhD, Vice President of Strategic Innovationm, ST Pharm

Application of PAT for Process Understanding and Control Strategy during Development and Manufacturing of Oligonucleotides

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It was not long time ago that making oligonucleotides at amounts sufficient for clinical trials was already a great success. As the number of oligonucleotide therapeutic applications is increasing, and chemical modifications together with understanding biological mechanisms better allow reaching out to larger patient populations via targeting more common diseases, the oligonucleotide community is facing with another challenge, i.e. how to make oligonucleotides at larger quantities for a better cost. There are multiple strategies to work towards these goals. In this talk, we will focus on understanding processes better and setting the right control strategies during manufacturing to have robust processes, improve cycle times, and minimize the potential number of deviations. In order to do this, PAT could be implemented for both development and manufacturing efforts. There are already number of studies out there for the oligonucleotides. We will further provide examples on utilization of PAT for the development and manufacturing of oligonucleotides.

Jale Muslehiddinoglu, Ph.D., Vice President of Strategic Innovation at ST Pharm, brings two decades of industry expertise within biotech and pharma. With a strong background in leading technical teams, she has spearheaded the development, implementation, and commercialization of API processes. Before her tenure at ST Pharm, Dr. Muslehiddinoglu crafted strategies for new modalities and played a pivotal role in establishing lab and production capabilities for oligonucleotides. Her innovative approaches have impacted the development of oligonucleotides. Dr. Muslehiddinoglu participated in initiatives such as EPOC and the oligonucleotide networking event, and ACS Green Chemistry Institute Pharmaceutical Roundtable for Oligonucleotides. She holds a Ph.D. in chemical engineering from Pennsylvania State University.