Contracting Office Address

National Institute of Standards and Technology (NIST),

Acquisition Management Division,

100 Bureau Drive, Mail Stop 1640,

Gaithersburg, MD, 20899-1640

Sources Sought Notice NIST-MML-25-SS08

Project Title: Lyophilized and Fixed Mammalian Cells for Cell Counting

This is a Sources Sought Notice ONLY.  Requests for copies of a solicitation will not receive a response.

This Notice is for planning purposes only and is not a Request for Proposal or Request for Quotation or an obligation on the part of the National Institute of Standards and Technology (NIST) for conducting a follow-on acquisition.  NIST does not intend to award a contract on the basis of this Notice, or otherwise pay for the information requested.  No entitlement or payment of direct or indirect costs or charges by NIST will arise as a result of submission of responses to this Notice and NIST use of such information. 

NIST recognizes that proprietary information and/or data may need to be conveyed in responding to this Notice to adequately demonstrate Contractor’s capabilities.  If Contractor needs to convey proprietary information or data, Contractor shall submit their response to this notice in two parts. 

Part I – Non-Proprietary Information and/or Data. 

Part II – Addendum Containing Proprietary Information and/or Data.  In addition to separating proprietary information and/or data into Part II, Contractor shall also clearly mark all proprietary information and/or data at all instances and/or on all pages on where included. In the absence of such identification, NIST will assume to have unlimited rights to all technical data provided in response to this Notice.

NO SOLICITATION DOCUMENTS EXIST AT THIS TIME.

Requirement:

NIST is seeking information on contractors who can provide the following:

Contract Development and Manufacturing Organization (CDMO)-type services for the preparation of lyophilized chemically fixed mammalian cells for research use only (not a licensed or regulated product).  Cell types can include Jurkat Clone E6-1 cells and HEK293T cells. The cells will be chemically fixed (non-viable) and provided by NIST to the contractors. Services to be provided could include a) formulation and lyophilization protocol development, b) scale-up from laboratory scale lyophilization experiments to final production scale and c) vialing of stable lyophilized cells. Contractors should address the following capabilities in their responses.

• Handling and formulation of cell materials such as cell counting, sample preparation, dilution with appropriate excipients, and aliquoting to prepare samples for the lyophilization process.
• Design and performance of early phase feasibility studies to inform scale up and at-scale production.
• “GMP-like” manufacturing including, but is not necessarily limited to, a quality management system, quality raw material sourcing and procedures, robust operating procedures, a deviation management system, etc.
• Delivery of lyophilized cells with intact morphological and staining attributes in 5 mL, amber, screw capped vials with a target of 2x106 cells per vial.
• The ability to accommodate prescribed sampling plans during the course of production.
• The ability to accommodate final formulation vialing and labeling.

Contractors may also submit information regarding the following optional capabilities in their responses.

• Revival of cells from frozen cryostock and culture expansion for adherent and/or suspension adapted cell lines.
• Processing of cell cultures for chemical fixation to obtain input material for lyophilization.

Contractor’s response should include all of the following that apply:

1. Documentation/Description of capabilities of biomanufacturing workflow which clearly demonstrates the capability to manufacture a lyophilized fixed-cell material, which may include, but is not necessarily limited to the use of cryoprotectants and excipients, and the appropriate temperature and pressure profiles to form final lyophilized cell material with retained cell morphology and staining attributes post-lyophilization.
2. Documentation/Description of capabilities of handling cells including cell counting, dilution, aliquoting etc to maintain consistency in cell count from vial to vial.
3. Documentation/Description of the container closure for a lyophilized cell material. The response should identify container closure, proposed volume, and any vendor or historical documentation demonstrated suitability for -20 °C (acceptable) to 25 °C (ideal) storage.
4. Doc