IGF::OT::IGF DEVELOPMENT OF BIOPHARMACEUTICALS

Leidos Biomedical Research, Inc., Frederick MD

Investigators

Abstract

The purpose of this project is to develop and produce a variety of biopharmaceuticals, for preclinical and human clinical studies, as directed by the Division of Cancer Therapy and Diagnosis (DCTD). Development will include using existing, as well as developing novel, manufacturing technologies and applying them to an overall manufacturing process to produce biopharmaceuticals at a scale suitable for their intended purpose. Technology transfer of the existing manufacturing process and analytical methods would take place. The manufactured items could support reference standards, preclinical studies, stability studies, and clinical studies. Analytical methods would be established for product quality and release, including long-term storage and handling stability. DCTD will review all new requests for biopharmaceutical development and production, including monoclonal antibodies, recombinant proteins, peptide and DNA vaccines, viruses, gene therapy products, and other biologics. Upon review, priority ranking will be provided to the contractor, and subsequently added to the queue for development and production. Generally, and depending on the state of the project upon initiation, the following Milestones are developed for each Task: Feasibility ? this involves dry lab and wet lab investigations to determine if a particular agent can be produced, purified, and characterized in small-to-medium amounts. Some assay development may occur in this milestone; Development ? this is a resource-heavy milestone that consists of establishing a scalable manufacturing process for the agent. It also includes most of the assay development required for releasing final vialed product and assessing stability, as well as establishing the cell banks for multiple production runs and initial reference standards; Scale-Up ? also known as a pilot or engineering run, this milestone establishes the manufacturing process at full scale and produces a high-quality batch of product that can be used for toxicology and IND-directed safety studies; and Manufacturing ? the final milestone consists of producing the GMP batch of product for clinical investigations. Regulatory documentation (i.e., CMC) and long term storage stability are included here.