Vialing of Material
This is a SOURCES SOUGHT NOTICE for market research purposes. THIS IS NOT A REQUEST FOR PROPOSALS OR A REQUEST FOR QUOTATIONS.
The National Institute of Standards and Technology (NIST)/Biomanufacturing Initiative includes development of a suite of fundamental measurement science, standards, and reference data to enable more accurate and confident characterization of key attributes of protein drugs. As part of that project, NIST has acquired an IgG1k monoclonal antibody intended for development into a NIST Reference Material. This material will be released with physicochemical data as well as quantitative data traceable to fundamental units of measurement, and is expected to be utilized as a system suitability tool in the biopharmaceutical industry.
NIST is seeking sources capable of thawing three (3) one liter containers (individually) of Bulk and diluting this material to 1/10 its original concentration to prepare "Reference Material". Each individual diluted Bulk will be aliquotted 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. Screw top cryovials compatible with -80 degree C storage must be used (Thermo Matrix #3741 or equivalent container/closure.) A total of one thaw/freeze cycle shall be used in going from Bulk to final Reference Material.
NIST is seeking responses from all responsible sources. Small businesses are defined under the associated NAICS code for this effort, 325414 Biological Product (except Diagnostic) Manufacturing, as those domestic sources having 500 employees or less. Please include your company's size classification in any response to this notice.
Companies that can meet all of the above requirements are requested to email a written response documenting their capability to carol.wood@nist.gov no later than the response date for this sources sought notice.
After the results of this market research are obtained and analyzed, NIST may conduct a competitive procurement and subsequently award a contract. If at least two qualified small business are identified during this market research stage, then any competitive procurement that resulted is anticipated to be conducted as a small business set-aside.
The following information is required to be provided as part of the response to this sources sought notice:
1. Documentation/description of capabilities which clearly demonstrates the capability to dilute, under aseptic conditions, three Liters 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. Screw top cryovials compatible with -80 degree C storage shall be used (Thermo Matrix #3741 or equivalent container/closure.) Flash freeze at -80 degrees C. Please provide vial-type capabilities;
3. Documentation of any relevant experience handling biopharmaceutical products such as monoclonal antibodies;
4. Any relevant documentation which demonstrates that the company can deliver the vialing requirements above as described above while maintaining absolute purity and monomeric purity;
5. Name and business size of the company;
6. Indication of number of days, after receipt of order that is typical for delivery for the material described herein;
7. Any other relevant information that is not listed above which the Government should consider in finalizing its market research.
Submission must be received not later than October 30, 2014, at 3:30 PM Eastern Time.
Carol A. Wood, Phone 301-975-8172, Fax 301-975-6273, Email carol.wood@nist.gov - Carol A. Wood, Phone 301-975-8172, Fax 301-975-6273, Email carol.wood@nist.gov
