14-22085 - Characterization of Human Cells (EMK) (14-22085)

Advance Contract Award Notice – (14-22085)

An ACAN is a public notice indicating to the supplier community that a department or agency intends to award a contract for goods, services or construction to a pre-identified supplier, thereby allowing other suppliers to signal their interest in bidding, by submitting a statement of capabilities. If no supplier submits a statement of capabilities that meets the requirements set out in the ACAN, on or before the closing date stated in the ACAN, the contracting officer may then proceed with the award to the pre-identified supplier.

BACKGROUND: The Human Health Therapeutics (HHT) Portfolio of the National Research Council (NRC) of Canada produces a HEK 293 suspension cells in serum free (SF) and animal origin free (AOF) media used as a complimentary cell for the production of viral vectors and biologicals to treat various types of human diseases. This cell line is a proprietary of NRC and patent approved by the US Patent and Trademark Office (No. 2139-14US FC/ntb). Since this cell line is intended to be used for the production of biologicals for human use, regulatory agencies such as the US FDA, HC, EMEA and PDMA require that the cell line’s master cell bank (MCB) must be produced and characterized according to current good manufacturing practices (cGMP) and good laboratory practices (GLP) to establish its identity and evaluate its safety. Upon characterization of the cGMP MCB, a vial is then taken to produce a series of working cells banks (WCB’s) necessary for process development and optimization with a goal to deliver a pure, safe and efficient biological product. This cell line is for licensing to various clients for the manufacturing of biologicals to treat or prevent different types of diseases. Requirement:

The National Research Council would like to issue a Sole Source Contract to Bio Reliance Corporation for reasons of unique technical processing capabilities as it relates to cell bank production/manufacturing and characterization of human embryonic kidney (HEK) 293SF-3F6 master cell bank (MCB) following regulatory guidelines and under current good manufacturing practices. Sole Source Justification: The proposed vendor “BioReliance” (BREL) Corporation has been in the business of cell banking since the early 1980’s with testing of over 1,000 master cell banks. Their manufacturing and testing facilities are certified by regulatory body agencies such as the United States Food and Drug Administration, Health Canada and the European Medicine Evaluation Agency ensuring that the manufacturing and characterization of the master cell banks follow the regulatory guidelines under current good manufacturing practices. They are the only known company that can do the turnkey adhering to regulatory compliance assuring the quality of the work. They do not outsource to external testing laboratories thus reducing delays establishing material transfer /confidentiality agreements.

They are the only known vendor that has the technical expertise to satisfy NRC requirement. The proposed contract is from December 2014 to December 2015 Cost Estimate of the Proposed Contract: $150,000 USD

Name and Address of Pre-Identified Supplier: BioReliance Corporation - 9900 Blackwell Road, Rockville, MD 20850 Supplier’s Right to Submit a Statement of Capabilities: Suppliers who consider themselves fully qualified and available to provide the services described in the ACAN may submit a statement of capabilities in writing to the contact person identified in this notice on or before the closing date of this notice.

The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

Inquiries and sta�serve le droit de négocier les conditions de tout marché avec les fournisseurs.

Les documents peuvent être présentés dans l'une ou l'autre des langues officielles du Canada.