Oligonucleotides and peptides can be distinguished from small molecules in several ways. However, in other ways they are also unlike conventional well-characterized therapeutic protein drugs. Specific regulatory guidance is not available for these types of modalities, leading to inconsistent approaches to setting specifications and lack of standard methodology for related substances.
This workshop is designed to provide a venue for informal discussions among the attendees from the industry, academicians and from regulatory agencies to identify common industry bench-marking practices as well as existing regulatory and scientific considerations that are applicable to the development of suitable control strategies for these moieties.
The two-day workshop will begin with an overview of commonly used control strategies for these modalities including process considerations, impurity thresholds, degradation and stability issues, approaches to developing appropriate specifications, formulation-specific aspects, analytical tools for characterization, new technologies, and acceptable paradigms for starting materials. We plan to have a couple of traditional talks about the available regulatory considerations from a US and EU perspective, and case studies to lay the groundwork for the discussions. The second day will cover these topics in more detail.