Monoclonal Antibody Reference Material Vialing

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

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 components, interfaces and equipment, and clearly mark restricted or proprietary components, interfaces and equipment, and clearly mark restricted or proprietary data and present it as an addendum to the non-restricted/non-proprietary information. In the absence of such identification, NIST will assume to have unlimited rights to all technical data in the information paper.

NO SOLICITATION DOCUMENTS EXIST AT THIS TIME.

Background:

The National Institute of Standards and Technology (NIST) Biomanufacturing Initiative includes the development of a suite of fundamental measurement methods, standards, and reference data to enable more accurate and confident characterization of key attributes of monoclonal antibody drugs. As part of the Biomanufacturing Initiative, NIST made an IgG1k monoclonal antibody known as NISTmAb, Reference Material (RM) 8671, available to the public on a cost-recovery basis. This material was released with physicochemical/quantitative data and has been utilized as a system suitability and calibration tool, as well as to support collaboration and novel technology development in the biopharmaceutical industry. In addition, NIST is developing a reference CHO cell line known as NISTCHO, RM 8675, that produces an IgG1k monoclonal antibody with the same primary amino acid sequence as RM 8671 and is intended for development into a NIST Reference Material that will be known as cNISTmAb, RM 8672. The NISTCHO, RM 8675, and cNISTmAb, RM 8672, will be released with physicochemical/quantitative data and, like NISTmAb, are expected to be utilized as system suitability tools for novel technology development and to enable fundamental research of CHO biology and biomanufacturing processes used in the biopharmaceutical industry.

Requirements:

NIST is seeking information from sources with the following capabilities:

1. Documentation/Description of capabilities which clearly demonstrates the capability to dilute, under aseptic conditions, three one Liter containers of Bulk biopharmaceutical formulation (individually) 10-fold to product (Reference Material, or RM) formulation (10 ± 0.5 mg/mL);


2. Documentation/Description of capabilities to aliquot each individual diluted RM lot into 10,000 (± 300) units of 800 µL each, for a total of 30,000 (± 1000) units of 800 µL each using an automated platform;


3. Documentation/Description of capabilities to use screw top cryovials compatible with -80°C storage (e.g., Thermo Matrix #3741of container/closure similar in all salient features) and to Flash freeze at -80°C. Please mention your vial-type capabilities;


4. Documentation of any relevant experience handling biopharmaceutical products such as monoclonal antibodies;


5. Documentation of any relevant capabilities and experience to demonstrate that the company can deliver the vialing requirements as described above while maintaining absolute purity and monomeric purity;


6. Name and business size of the company;


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


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

Interested parties shall describe the capabilities of their organization as it relates to the product described above. NIST anticipates issuing a Request for Quotation within 120 days of this post’s closing.

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, 561910, is $19.5M. 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, Unique Entity Identifier (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 service described in this notice.


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


5. Indication of whether the service 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 twelve (12) pages. The responses must be in MS Word format. Pages shall be 8½-inch x 11-inch, using Times New Roman 11 Point Font. Each page shall have adequate margins on each side (at least one inch) of the page. Header/footer information (which does not include any information to be analyzed) may be included in the 1" margin space.

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