02_04081_SOW_Bovine_Serum.docx

STATEMENT OF WORK

Preparation of Candidate Standard Reference Material (SRM) 927f Bovine Serum Albumin (7% Solution)

I. BACKGROUND

Standard Reference Material (SRM) 927 Bovine Serum Albumin (7% Solution) was originally issued in 1979. This SRM is used in the standardization of procedures for the measurement of total protein. When the supply of this material was exhausted, SRMs 927a – SRM 927e were issued as renewals. Sales of SRM 927e, the current issue of this SRM, average approximately 400 units per year, and the supply of SRM 927e is projected to be depleted within the next three years. Customers for this SRM include clinical diagnostics manufacturers and the biopharmaceutical industry, and these customers have stressed the importance of maintaining availability of SRM 927. SRM 927f will be acquired as a renewal material to replace SRM 927e when its supply is depleted. Because of the bovine origin of the bovine serum albumin used in preparation of SRM 927f and related concerns about transmission of bovine spongiform encephalopathy (BSE, commonly known as mad-cow disease), certain requirements regarding collection of the bovine blood must be met to allow NIST’s distribution of this SRM to international customers.

II. SCOPE OF WORK

The contractor shall provide 30,000 ampoules of bovine serum albumin (BSA) solution to NIST according to the specifications below.

III. SPECIFICATIONS

The contractor shall prepare 30,000 ampoules of SRM 927f Bovine Serum Albumin (7% Solution) with the following specifications:

1) Bovine blood used to prepare the bovine serum albumin (BSA) shall be collected from cattle sourced in the United States. Bovine blood shall be collected and handled under sanitary conditions in accordance with procedures for products for pharmaceutical use. Only blood from cattle/carcasses that have passed ante-mortem and post-mortem U.S. Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) inspection shall be used. The contractor shall provide documentation that these requirements have been met

2) No additives shall be used in purification of the BSA protein from bovine blood. BSA used in the preparation of SRM 927f must have a minimum total protein concentration of 99% or greater, as determined by electrophoresis, and a BSA purity of 99% or greater. All BSA shall be from a single lot of material. The contractor shall provide documentation that these requirements have been met.

3) The BSA shall be dissolved in 0.02 mol/L sodium chloride at a concentration of 7% ± 0.1% (mass fraction) and the pH adjusted to 6.5 to 6.8 with 1.0 mol/L sodium hydroxide

4) The BSA solution shall be sterilized by membrane filtration and tested for sterility using United States Pharmacopeia (USP) guidelines for sterility testing (USP <71>). The contractor shall provide documentation that these requirements have been met.

5) Ampoules (5 mL) shall be clear glass, pre-scored, and capable of withstanding refrigeration (2 ºC – 8 ºC) without cracking or breakage

6) Each ampoule shall contain 2.2 mL BSA solution (filled with an accuracy of 0.1 mL)

7) Ampoules shall be labeled, using labels provided by NIST, and flushed with argon prior to filling. Ampoules shall be sealed after filling with BSA solution

8) Ampoules shall be transferred, in fill order, from the ampouling equipment to a box in a "Z" pattern, filling each row left to right. The location of the first ampoule in each box will be noted on each side of the outside corner of the box, and boxes will be numbered sequentially. Boxes shall be labeled to indicate their contents.

9) Boxes of filled ampoules shall be stored under refrigeration (2 ºC – 8 ºC) until overnight cold shipment to NIST. Ampoules shall not be frozen because of potential breakage.

10) Delivery of SRM 927f ampoules to NIST shall be within 90 days after receipt of ampoule labels from NIST by the contractor

11) Ampoules of SRM 927f received by NIST shall be free of cracks, breakage, and discoloration. Ampoules showing evidence of charring will not be accepted.

IV. PERIOD OF PERFORMANCE

The period of performance shall be 120 days after receipt of the award. NIST shall provide the ampoule labels within 14 days of the award, and ampoules of SRM 927f shall be delivered to NIST within 90 days of receipt of the labels by the contractor.

V. PLACE OF PERFORMANCE

All work shall be completed at the Contractor’s facility.

VI. GOVERNMENT FURNISHED PROPERTY

NIST shall provide labels to be applied to the ampoules prior to filling. Labels will be provided to the contractor no later than 14 days after the date of the award.

VII. DELIVERABLES

VIII. PERFORMANCE REQUIREMENT SUMMARY

The Contractor shall demonstrate that all performance standards in this statement of work have been met.

The government requires 10 days for inspection and acceptance testing. The TPOC shall inform the Contractor within 14 days if the deliverables have been accepted. Invoicing cannot proceed without notification of acceptance from the TPOC.