SOW - Revised.pdf

3.0 Statement of Work

3.1 Scope of work: The goal of this project is to increase FADDL’s capacity to produce recombinantly expressed antigens to establish the expanded diagnostic mission at NBAF through acquiring a lab scale bioreactor system. This expanded mission includes developing diagnostic program for high consequence zoonotic pathogens that require BSL4 laboratory conditions for manipulation. This work will be a joint effort between the BSL4 Core section, Protein Core, Zoonotic Core, and the Reagents and Vaccine Services Section of FADDL at NBAF.

3.2 Background: The purpose of procurement is to establish the capacity to produce recombinantly expressed antigens via a bioreactor system that can perform the following functions:

a. Multispecies cell cultivation with a unified set of consumables: mammalian, insect, bacterial, and yeast. This will offer the flexibility to utilize the most appropriate expression system for antigen production without additional equipment or consumables.

b. High degree of documentation and control of run parameters for generating standardized, accredited reference material.

c. Harmonization with bioreactor systems currently in use within Reagents and Vaccine Services section at PIADC and Biologics Development Module at NBAF for seamless transfer of operations and scalability.

3.3 Contract Type

This is a firm-fixed-price contract. The payment provided for in the contract constitutes full compensation for furnishing all materials, equipment, and labor, and performing all work under the contract in a complete and acceptable manner. Compensation for all work specified or essential to completion of the project shall be included in the total price. The payment provided in the contract includes compensation for all risk, loss, damage, and expense arising out of the nature of the work or its prosecution, subject to the conditions of the contract.

3.3 Technical Requirements/Tasks

The contractor shall furnish one configurable Eppendorf BioFlo 320 System (see attachment 1, Product Specifications document).

Required features/salient characteristics:

• Cell culture species flexibility: mammalian, insect, bacterial, and yeast.

• Continuity of operation of standardized protocols with Eppendorf BioFlo 320 currently in use with Reagents and Vaccine Services Section (RVSS) at Plum Island Animal Disease Center (PIADC).

• Seamless scaleup of production volumes beyond 50L with Biologics Development Module (BDM) manufacturing scale Eppendorf bioreactor systems.

• High degree of input control and configurability: gas flow and feed controls, pH and dO2 sensor options, wide array of single use vessel options.

• Scalability options: 1L to 50L production volume.

• Intricate tracking of run parameters to ensure compliance with ISO17034 standards.

• Hard-sided plastic vessel compatible with NBAF biosecurity policies with impeller driven aeration.

• Power requirements: 120/240V, 50/60Hz

3.4 Deliverables/Schedule: The contractor must provide all the necessary and proper equipment for unloading the equipment, transporting it to the laboratory and installing the equipment. The government will not provide any equipment or labor for moving or transporting or installing the equipment at the laboratory. The contractor shall demonstrate the equipment is functioning according to the manufacturer’s specifications upon completion of the installation.

Must be delivered within 90 days of award

The contractor shall schedule delivery/installation with the Government Technical Point of Contact or designee at least three (3) weeks in advance. A user manual shall be provided at the time of installation.

3.5 Security: The contractor shall comply with all established security policies at (insert name of facility) and shall be escorted and accompanied at all times while at the facility. The contractor shall complete required paperwork for access to the facility.

3.6 Technical Point of Contact:

Jacob Stockton: 417-606-0607, email Jacob.stockton@usda.gov

3.7 Place of Delivery: USDA APHIS, FADDL, National Bio and Agro-Defense Facility, 1200 Kretschmer Drive, Suite 100, Manhattan, Kansas 66502.

mailto:Jacob.stockton@usda.gov