Currently there are no ICH guidelines for Oligonucleotide Pharmaceutical Development (drug substance or drug product). There are just about a handful of white papers published in various journals or case studies presented in various scientific forums are available on this important field of study. Considering that there are no ICH guidelines for development and manufacture of oligonucleotide drug substances a systematic approach for process, scale up, manufacturing and analytical development is an important need.
Towards addressing this need we will present the challenges encountered during scale up, synthesis and analytical development based on a case study of a therapeutic RNA oligonucleotide drug substance.
This webinar will attempt to focus on how to design and implement a QbD based on sequence or modifications present in the molecule with a focus on meeting the specification criteria. It will help the participants to enhance their knowledge in process and analytical development of an oligonucleotide and aid in studying the factors for an efficient scale up of an oligonucleotide drug substance to meet the desired quality specifications.
The webinar will cover important topics related to the challenges on scale, QbD/DoE, pilot scale manufacturing, analytical HPLC/UPLC/LCMS development and will enable the participants to formulate a guidance for effective process development to meet the quality specifications of a therapeutic drug substance.
Ramesh Rajeswaran,
Head, Oligonucleotide Pharmaceutical Development
Ramesh has a PhD in chemistry and has over 17 years of experience developing processes and scaling up of small molecules, especially heterocyclic molecules, from lab scale to pilot scale. He specializes in process development of molecules to cater to the various phases of clinical development from tox to clinic, including GMP manufacturing. More recently he has been working in the field of oligonucleotides, establishing this function at Syngene. He has been instrumental in setting up and commissioning the process development and pilot scale manufacturing facilities at Syngene. Over the last three years he has been working on the process development and scale-up of oligonucleotides from µmol to mmol scales.
- QbD/DoE Process Development
- Oligonucleotide Scale up
- Pilot Scale Manufacturing
- Analytical Development
- Head of R&D
- Head of Manufacturing
- Project Managers
- Process Chemists
- Analytical Chemists
- Head of Oligonucleotide Synthesis and Scale-up
- Head of Operations
- Head of Discovery Chemistry
- Head of Process R&D
