Lyophilized and Fixed Mammalian Cells for Cell Counting

Active

Contract Opportunity

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. Document/Description of mechanisms to enable assurance of homogeneity across individual cell containers. This may include, but is not necessarily limited to, process controls, hold vessel for bulk homogenization, or other means.


5. Document/Describe batch records and/or process data that have been made available.


6. Documentation of any relevant experience in lyophilizing mammalian cells, including the types of cells worked with and any special techniques or technologies employed.


7. Indication of number of days, after receipt of an order that is typical for delivery.


8. Documentation/Description of capabilities which clearly demonstrates the capability to fill and cap under aseptic conditions, bulk lyophilized product (individually). Fill characteristics of the freeze-dried product should include but not be limited to: Mean fill mass (g), CV of fill mass (%), Mean dry weight, CV of dry weight (%), Mean Residual moisture (%), CV of residual moisture (%), Mean oxygen head space (%), CV of oxygen space (%), Microbiological results. Please mention your vial-type capabilities.


9. Relevant price information such as Contractor’s current established price lists or informational estimates of prices for scope of capabilities included in Contractor’s response.

Interested parties shall describe all relevant capabilities of their organization. NIST anticipates issuing a Request for Quotation in the second quarter of FY2025 and awarding a contract no later than the fourth quarter of FY2025.

NIST is seeking responses from all responsible sources, including large and small businesses. The small business size standard associated with the NAICS code for this effort, 325414, is 1,250 employees. Please include your company’s size classification and socio-economic status in any response to this notice.

After results of this market research are obtained and analyzed, NIST may conduct a competitive procurement and subsequently award a contract. Companies that can provide such services are requested to email a written response describing their abilities to Donald.Graham@NIST.gov no later than the response date for this sources sought notice.

The following information is requested to be provided as part of the response to this sources sought notice:

1. Name, Address, SAM UEI, CAGE code, and point of contact information of your company.


2. Any information on the company’s small business certifications, if applicable.


3. Description of your company’s capabilities as they relate to the services described in this notice.


4. A description of your company’s previous experience providing the services described in this notice.


5. Indication of whether the services described in this notice are currently offered via your company’s GSA Federal Supply Schedule (FSS) contracts, Government-wide Acquisition Contracts (GWACs), or other existing Government-wide contract vehicles; and, if so, the contract number(s) for those vehicles.


6. Any other relevant information that is not listed above which the Government should consider in finalizing its market research.

Responses are limited to a total of twenty (20) pages of US Letter size (8½-inch x 11-inch). The responses must be in either Microsoft Word or Adobe PDF format. Header/footer information (which does not include any information to be analyzed) may be included in the 1" margin space.

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