Manufacturing: Monoclonal Antibody Reference Material

Status
Inactive
Published Date
November 16th, 2023
Response Deadline
December 16th, 2023
Location
Gaithersburg, MD, USA
Notice Type
Sources Sought
Solicitation No.
NIST-MML-24-SS05

Buyer

COMMERCE, DEPARTMENT OFNATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGYDEPT OF COMMERCE NISTGAITHERSBURG, MD, 20899, USA

Summary

Sources Sought COMMERCE, DEPARTMENT OF NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY is seeking vendors who can potentially perform additional upstream/downstream process development and scale-up to produce 1-5 kg of cNISTmAb from a single bioreactor run. The material is intended for research use and is not intended for animal or human consumption, clinical testing, or therapeutic use. The intent is to produce research-grade material in an environment representative of all salient features of biopharmaceutical biomanufacturing. Vendors should indicate their capabilities regarding "GMP-like" manufacturing, delivery of mAb at 100 mg/mL in L-Histidine, documentation/description of capabilities of biomanufacturing workflow, container closure for a 100 mg/mL mAb substance, assurance of homogeneity across individual mAb substance containers, batch records and/or process data, relevant experience handling CHOZN cell lines and manufacturing of biopharmaceutical products, and the ability to deliver a portion of the mAb as finished Reference Material. Interested parties should email a written response to donald.graham@nist.gov. NIST anticipates issuing a Request for Quotation in the second quarter and awarding a contract no later than the fourth quarter of fiscal year 2024.

Description

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. The NIST Biomanufacturing Program is directed toward developing a suite of fundamental measurement science, standards, and reference data to enable more accurate and confident characterization of key attributes of protein drugs that are directly linked to their safety and efficacy.  NIST has acquired a CHO cell capable of expressing at >2 g/L, based on the CHOZN cell line (NISTCHO, RGTM 10197, https://tsapps.nist.gov/srmext/certificates/10197.pdf.)  NIST has performed 2L batch expression of the cNISTmAb using a commercially grade media and have achieved titers >2 g/L and quality characteristics of a reasonable degree of sameness to its reference product (RM 8671).  NIST is seeking vendors who can potentially perform additional upstream/downstream process development and scale-up to produce 1-5 kg of cNISTmAb from a single bioreactor run. The material is intended for research use.  It is not intended for animal or human consumption, clinical testing, or therapeutic use.   The intent is to produce research-grade material in an environment representative of all salient features of biopharmaceutical biomanufacturing. Requirement Contractors responding to this notice should indicate their capabilities regarding: “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 mAb at 100 mg/mL in L-Histidine.    Documentation/Description of capabilities of biomanufacturing workflow which clearly demonstrates the capability to manufacture “drug substance-like" material, which may include, but is not necessarily limited to cell culture, viral inactivation, two stage purification and filtration to form final mAb substance. Documentation/Description of the container closure for a 100 mg/mL mAb substance.  The response should identify container closure, proposed volume, and any vendor or historical documentation demonstrated suitability for –70°C storage.  Document/Description of mechanisms to enable assurance of homogeneity across individual mAb substance containers. This may include, but is not necessarily limited to, process controls, hold vessel for bulk homogenization, or other means.  Document/Describe batch records and/or process data that have been made available. Documentation of any relevant experience handling CHOZN cell lines and manufacturing of biopharmaceutical products such as monoclonal antibodies. Indication of number of days, after receipt of an order that is typical for delivery; Additional capabilities The ability to deliver a portion of the mAb as finished Reference Material. If applicable, the following information is requested to be provided as part of the response to this sources sought notice: Documentation/Description of capabilities which clearly demonstrates the capability to dilute, under aseptic conditions, one Liters of Bulk biopharmaceutical formulation (individually) 10-fold to product (reference material, or RM) formulation (10 +/-0.5 mg/mL). Documentation/Description of capabilities to aliquot each individual diluted RM lot into 10,000 (±300) units of 800 µL each, for a total of 10,000 (±1000) units of 800 µL each using an automated platform. Screw top cryovials compatible with -80°C storage shall be used (e.g. Thermo Matrix #3741of container/closure similar in all salient features).  Flash freeze at -80°C.  Please mention your vial-type capabilities.  Any relevant documentation which demonstrates the companies capability to deliver the vialing requirements above as described above while maintaining absolute purity and monomeric purity. Interested parties shall describe the capabilities of their organization as it relates to the items as described above.  NIST anticipates issuing a Request for Quotation in second quarter and awarding a contract no later than fourth quarter of fiscal year 2024. NIST is seeking responses from all responsible sources, including large and small businesses.  The small business size standard associated with the NAICS codes for this effort, 541714, is 1000 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: Name, Address, Government Unique Identification number, CAGE code, and point of contact information of your company. Any information on the company’s small business certifications, if applicable. Description of your company’s capabilities as they relate to the items described in this notice. A description of your company’s previous experience providing the items described in this notice. Indication of whether the items 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. Any other relevant information that is not listed above which the Government should consider in finalizing its market research. Any pricing information related to the items described in the notice. 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.

Contact Information

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Sources Sought