AMBIS_1973527_-_SOW.pdf

NIAID-RFQ19-1973527

Statement of Work – Metabolic Analyses CHO Cell Characterization

A. Background Information The Vaccine Research Center (VRC) of the National Institutes of Allergy and Infectious Diseases (NIAID) is developing vaccines for HIV-1 and other viruses. The goal of the Vaccine Production Program Laboratory (VPPL) is to efficiently translate candidate research vaccines into materials for proof-of-concept clinical trials and to enable advanced development and licensure by partners. The VPPL is responsible for process design and development, clinical good manufacturing practices (CGMP) manufacturing, pre-clinical safety testing and regulatory activities for all VRC products. VPPL has developed a robust CHO-DG44 expression platform for the production of VRC clinical candidate material for proof-of-concept studies. As an initiative to further streamline the process to increase the yields and quality attributes of the product, the research is characterizing high expressing cell lines with the control (Host) and low producing clones.

B. Scope The scope of the requirement is to provide metabolic analyses of cell characterization to further optimize the process design.

C. Purpose and Objective of Service Contractor must provide metabolic analysis of the CHO-DG44 cell characterization and information on the cellular pathways to allow the VPPL to potentially identify the bottlenecks in cell behavior to a particular attribute. Information that arises from these analyses will be used to future optimize the process platform to facilitate efficiency in the overall process design.

D. Contract Requirements Contractor must provide metabolic analysis of 4 samples (cell and supernatant) per clone taken at different time points during a 14-day platform fed-batch process. There will be 32 samples for each project. Contractor must provide the service for 2 projects with the option of 3 additional projects. The status of metabolic pathways such as Glycolysis, Pentose Phosphate Pathway, Redox Pathway and Glycosylation Pathways for each cell line must also be provided. Data shall be statistically analyzed by a seasoned statistician and biochemical interpretation of significant findings shall be performed by a PhD-level biologist trained in metabolomics.

E. Government Furnished Materials/Information Samples and sample information, if necessary, shall be provided by the Government.

F. Reporting Requirement and Deliverables Results must be delivered in a data table (excel format) listing every structurally named metabolite identified and the relative abundance of each metabolite. The status of metabolic pathways such as Glycolysis, Pentose Phosphate Pathway, Redox Pathway and Glycosylation Pathways for each cell line must also be provided. Furthermore, a graphical representation of the trends for each metabolite with time within the pathway must be provided.

G. Inspection and Acceptance Data reports (excel format) and graphics shall be inspected and approved by a Government official.

H. Period of Performance and Timeline Turnaround time shall be 12-16 weeks from receipt of samples and necessary information. The period of the performance shall be covered for 365 days after date of award.