Singota Solutions Capacity Update May 2024: Large Molecule Development

The paradox of the CMC path across the development continuum is that its complexity increased gradually while the timelines to achieve clinical milestones decreased to levels hard to imagine few years ago.

The requirements for pharmaceutical product development, control, and manufacturing framework along with management of changes have been the subject of numerous guidance documents and forums. Nevertheless, applying such framework to the reality and specificity associated with each product serving a particular clinical and regulatory strategy requires complex connectivity and integration of efforts across multiple fields of expertise.

This presentation from the May 2024 OPCU event covers approaches we are using at Singota Solutions to assess the programs’ status quo and the desired outcomes. Starting with Questionnaires and Gap Assessments followed by Risk assessments, we define together with the sponsors the scope of work that is tailored to the desired clinical presentation and the core of required product knowledge. Readiness for initiating the technology transfer and product introduction to Singota’s Analytical and Manufacturing platforms are initiated first virtually, as a “make-a-batch” paper-based exercise. The detailed activity and execution plan follows. Singota’s Analytical, Product and Process Development, and Manufacturing capabilities along with the tools deployed to create sponsor’s clinical materials supply and the knowledge required to demonstrate product and process understanding are featured during this presentation.