Ex post: CorA Drug Product + Phase 1

Specifications of the required services are set out in the document "B01 Service Specifications". The services shall be governed by the enclosed Standard Terms and Conditions of Purchase (document B02) and the Master Contract Services Agreement (document B03). The expected services of the CorA-DP project are divided into two phases that will be awarded simultaneously to the same bidder. The call-off of the services for phase 2 is subject to financing until further notice. Phase I: The University Hospital Bonn aims to progress with the natural product Corallopyronin A (CorA) into a Phase I clinical trial. Therefore, the University Hospital Bonn is looking for a service provider that can fulfill the technical transfer of a spray drying process of CorA (formation of an amorphous solid dispersion) followed by implementation and development of downstream processes such as dry granulation, capsule filling and tableting (ER matrix). The manufacturing of chemistry, manufacturing, and controls (CMC) batches is required and stability data should be generated to support early regulatory activities and to enable the preparation of necessary regulatory documentation to facilitate a first in human study. The service should continue with Clinical Trial Materials (CTM) batch manufacturing, testing, and certification. Phase II: In order to save drug substance resources by minimizing required stability studies and offer high flexibility in adapting phase I clinical studies, an ideal partner would offer immediate access to the clinical trial unit and conduct clinical phase I. Thus, the period between manufacturing of CTS and first patient in would not be more than 2 weeks. The entire process will be awarded to the CMO as a phased contract and should run sequentially after successful completion of each work package. A Master Service Agreement (MSA) or framework agreement is preferred to facilitate the commission of the required work packages in form of Statements of Work (SoWs). There will be a commercial agreement and an additional quality assurance agreement.