Next Generation Cell Culture Module Hardware for Certification and Use on the International Space Station
Synopsis – Nov 29, 2011
General Information
Solicitation Number: NNA12416240L
Posted Date: Nov 29, 2011
FedBizOpps Posted Date: Nov 29, 2011
Recovery and Reinvestment Act Action: No
Original Response Date: Dec 14, 2011
Current Response Date: Dec 14, 2011
Classification Code: A — Research and Development
NAICS Code: 541711 – Research and Development in Biotechnology
Contracting Office Address
NASA/Ames Research Center, JA:M/S 241-1, Moffett Field, CA 94035-0001
Description
NASA/ARC has a requirement for modification of the Space Shuttle flown Cell Culture Module (CCM) hardware for certification and use on the International Space Station (ISS) in order to conduct on-orbit cell biology research. The Space Shuttle proven technology will enable long duration research with an automated system that also allows ISS crew intervention. The modification of the existing CCM will enable leveraging on existing technologies and hardware to fit within the limited time schedule and budget available to meet the near-term need date for use on-orbit. The ISS certified hardware will preserve flight qualified and proven systems while reconfiguring the architecture for individual access to the biology for experiment initiation, refurbishment or sample storage and preservation. The company must have proven successful space flight history including demonstrated flight experience with a cell culture hardware unit on repeated (more than one) Space Shuttle or other space vehicle flights where the hardware and research parameters were nominal to demonstrate robustness and longevity of developed flight hardware.
The Next Generation CCM hardware must have the following hardware and documentation specifications:
1. 2 flight units capable of providing/regulating environmental conditions that support tissue culture incubation – compliant with all NASA safety, integration and verification requirements for launch on any spaceflight vehicle and installation/use on the ISS as required in Space Station Program (SSP) Documents 50835 2. 1 engineering/training unit for ground only use 3. Removable cassettes (flow path type assemblies), capable of sustaining cell cultures and employing connectors to attach user-defined/developed specimen chambers, to be integrated into the flight or ground units 4. Submission of a NASA-defined hardware acceptance data package that includes certificate of conformance, hardware build procedures, acceptance test procedures and results, hardware drawings, non-conformance reports, completed verification documentation, hardware operations (ground processing and flight utilization) and malfunction procedures
Hardware subcomponent requirements:
1. Capable of attaching hollow fiber bioreactors 2. Capable of attaching custom specimen chambers (e.g. optical microscope compatible versions) 3. Capable of supporting adherent and non-adherent cells and 3D tissue cultures 4. Temperature control of +4 degrees Celsius to +39 degrees Celsius 5. Electronic boards, firmware, software and programming for operating the hardware 6. Capable of providing Carbon Dioxide (CO2) level (0 to 5 %) 7. Must contain fluid loops and oxygenator system for medium supply to specimen chambers for gas exchange and perfusion 8. Capability to customize fluid/medium delivery rate and automated fluid injection into the culturing chamber with independent flow rates for individual flow path systems 9. Capable of automated fixative addition and sample withdrawal 10. Capable of monitoring temperature, CO2 level, relative humidity, and data collection 11. Ability to downlink data (delayed or real time) and maintain internal data memory 12. Capable of integrating into and operating in the ISS ExPRESS rack 13. Capable of providing up to three layers of containment 14. Documentation to support/validate qualification and acceptance tests, analyses, demonstrations and inspections 15. Ability to interface with the ISS and Commercial Resupply Services (CRS) rack, power, data downlink and command common interfaces in order to remote command if required 16. Ability to meet all ISS flight certification, verification, and safety requirements per NASA SSP 57000 and obtain approval from the NASA Johnson Space Center (JSC) Payload Safety Review Panel for flight and operations 17. Ability to meet and verify all requirements for all launch vehicles addressed in NASA SSP 50835 (Common Interface Requirements Document)
The hardware must also have the additional on-orbit capabilities:
1. Allow crew access, with appropriate levels of containment and upstream stops, to the specimen incubator chamber 2. Provide the capability to remove specimen culture containers for sampling, transfer to cold stowage, replacement with new culture containers, and in-situ analysis with existing on-orbit microscope systems 3. Provide capability to remove spent cell culture medium bags, fixative solution bag and cell factors bags for change out to new bags 4. Provide the capability to change out the entire flow path assembly on orbit 5. Support the ability to receive a fully assembled flow path system to be installed on-orbit 6. Use a common connector to allow insertion of other types of cell cultures to expand functional use beyond the hollow fiber bioreactors or for manual sampling or fluid injections 7. Provide two layers of containment (or appropriate level of containment) for any disconnected subcomponent 8. Ground command capability for remote operation and control 9. Gas system capable of long duration supply (~60 days) with medical grade Oxygen (20%), Carbon Dioxide (5%) and balanced Nitrogen
NASA/ARC intends to purchase the modified Next Generation CCM and its subcomponents from Tissue Genesis, Inc. (TGI), a small business concern. TGI is composed of managers and engineers responsible for the CCM payload development and experimental flight series, totaling twenty-one successful Space Shuttle missions. This TGI core team includes the Program Manager, Deputy Payload Manager, Senior Bioengineer and previous Principle Investigators for the CCM series. The current TGI team was expanded to include additional bioengineering and biology expertise to successfully integrate and fly CCM experiments on twenty-one Space Shuttle missions, including the most recent STS-118, STS-131 and STS-135 flights. TGI is a world expert in hollow fiber flow through and perfusion systems and can modify existing technologies and hardware subcomponents in order to meet the long duration research needs of the ISS. The TGI team of CCM payload experts is a uniquely capable provider of services owing to their extensive experience and unique knowledge required to successfully develop and fly cell culture experiments within the CCM payload and ultimately integrate onto the ISS. The TGI facility contains in-house engineering and science research and development laboratories to conduct biological optimization and engineering development in parallel with cross-functional product development awareness. There is no other company known with the CCM payload operational knowledge, CCM specific science integration expertise, cell biology micro-gravitational operational understanding, and facilities to provide modification to the Space Shuttle flown CCM for certification and use on the ISS.
The Government does not intend to acquire a commercial item using FAR Part 12.
Interested organizations may submit their capabilities and qualifications to perform the effort in writing (e-mail is preferred) to the identified point of contact not later than 4:30 p.m. local time on 14 December 2011. Such capabilities/qualifications will be evaluated solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. A determination by the Government not to compete this proposed effort on a full and open competition basis, based upon responses to this notice, is solely within the discretion of the government.
Oral communications are not acceptable in response to this notice.
All responsible sources may submit an offer, which shall be considered by the agency.
NASA Clause 1852.215-84, Ombudsman, is applicable. The installation Ombudsman is Deborah L. Feng, NASA Ames Research Center, Mail Stop: 200-9, Moffett Field, CA 95035-1000.
Point of Contact
Name: Justin C. Pane
Title: Contracting Officer
Phone: 650-604-5621
Fax: 650-604-0932
Email: justin.c.pane@nasa.gov
