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CASE STUDY

U.S. Based Independent Biotech Company Finds Success in Syner-G’s Capabilities in Manufacturing for Both Pre-Clinical and Clinical Trials Case Studies

Yumanity Therapeutics, headquartered in Boston, was established in December 2014 as an independent biotechnology company focused on drug development targeting neurological diseases where protein misfolding is a key concept, such as Alzheimer’s, Parkinson’s disease, and Lou Gehrig’s disease (amyotrophic lateral sclerosis).

Challenge

Bringing new registration-ready drugs through discovery and clinical trials is a resource-intensive process that requires many levels of expertise. As a small company, Yumanity did not have the experienced professionals needed to manage each stage of the manufacturing, quality, and regulatory processes (collectively called CMC – Chemistry, Manufacturing and Controls). It would also not have been practical to hire full-time staff across the each of the CMC functions (e.g., drug substance, drug product, analytical, etc.) for fractional needs.

Solution

Syner-G was tasked to review and bring in the right perspective of a variety of GMP documentation – executed BMRs, validation reports, analytical reports, investigation reports related to OOS, deviations, etc. with an objective of improving the documents to be ready for filing.

Results

Syner-G reviewed each documentation and provided suggestions/comments/guidance to the CDMO to bridge the gaps observed. This enabled the CDMO to provide acceptable explanation and clarity to each gap identified
in the documentation including investigation reports of incidents, OOS, and deviations. Appropriate training by Syner-G experts were provided to the stakeholders at the CDMO along with on-site visits. A tracker was maintained listing observations of each document and reconciliations were recorded. As the assignment progressed, the number of observations per document decreased to a minimal, providing documented evidence of improvement in quality of documentation. The progress of the assignment was communicated to the client through weekly reports and regular virtual meetings.

  • Client was able to receive technically sound and ready to file documentations from the CDMO, thereby saving time, efforts and delays for filing.

  • Overall quality of documentation was improved at CDMO site.