A--NEXT GENERATION CELL CULTURE MODULE HARDWARE FOR CERTIFICATION AND USE ON THEINTERNATIONAL SPACE STATION

NASA/ARC has a requirement for modification of the Space Shuttle flown Cell CultureModule (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 technologywill enable long duration research with an automated system that also allows ISS crewintervention. The modification of the existing CCM will enable leveraging on existingtechnologies and hardware to fit within the limited time schedule and budget available tomeet the near-term need date for use on-orbit. The ISS certified hardware will preserveflight qualified and proven systems while reconfiguring the architecture for individualaccess to the biology for experiment initiation, refurbishment or sample storage andpreservation. The company must have proven successful space flight history includingdemonstrated flight experience with a cell culture hardware unit on repeated (more thanone) Space Shuttle or other space vehicle flights where the hardware and researchparameters were nominal to demonstrate robustness and longevity of developed flighthardware. The Next Generation CCM hardware must have the following hardware and documentationspecifications:1. 2 flight units capable of providing/regulating environmental conditions thatsupport tissue culture incubation compliant with all NASA safety, integration andverification requirements for launch on any spaceflight vehicle and installation/use onthe ISS as required in Space Station Program (SSP) Documents 508352. 1 engineering/training unit for ground only use3. Removable cassettes (flow path type assemblies), capable of sustaining cellcultures and employing connectors to attach user-defined/developed specimen chambers, tobe integrated into the flight or ground units4. Submission of a NASA-defined hardware acceptance data package that includescertificate of conformance, hardware build procedures, acceptance test procedures andresults, hardware drawings, non-conformance reports, completed verificationdocumentation, hardware operations (ground processing and flight utilization) andmalfunction procedures Hardware subcomponent requirements:1. Capable of attaching hollow fiber bioreactors 2. Capable of attaching custom specimen chambers (e.g. optical microscope compatibleversions)3. Capable of supporting adherent and non-adherent cells and 3D tissue cultures4. Temperature control of +4 degrees Celsius to +39 degrees Celsius5. Electronic boards, firmware, software and programming for operating the hardware6. Capable of providing Carbon Dioxide (CO2) level (0 to 5 %) 7. Must contain fluid loops and oxygenator system for medium supply to specimenchambers for gas exchange and perfusion 8. Capability to customize fluid/medium delivery rate and automated fluid injectioninto the culturing chamber with independent flow rates for individual flow path systems9. Capable of automated fixative addition and sample withdrawal10. Capable of monitoring temperature, CO2 level, relative humidity, and datacollection11. Ability to downlink data (delayed or real time) and maintain internal data memory12. Capable of integrating into and operating in the ISS ExPRESS rack13. Capable of providing up to three layers of containment 14. Documentation to support/validate qualification and acceptance tests, analyses,demonstrations and inspections15. 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 required16. Ability to meet all ISS flight certification, verification, and safetyrequirements per NASA SSP 57000 and obtain approval from the NASA Johnson Space Center(JSC) Payload Safety Review Panel for flight and operations17. Ability to meet and verify all requirements for all launch vehicles addressed inNASA 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, tothe specimen incubator chamber2. Provide the capability to remove specimen culture containers for sampling,transfer to cold stowage, replacement with new culture containers, and in-situ analysiswith existing on-orbit microscope systems3. Provide capability to remove spent cell culture medium bags, fixative solutionbag and cell factors bags for change out to new bags4. Provide the capability to change out the entire flow path assembly on orbit5. Support the ability to receive a fully assembled flow path system to be installedon-orbit6. Use a common connector to allow insertion of other types of cell cultures toexpand functional use beyond the hollow fiber bioreactors or for manual sampling or fluidinjections 7. Provide two layers of containment (or appropriate level of containment) for anydisconnected subcomponent8. Ground command capability for remote operation and control9. Gas system capable of long duration supply (~60 days) with medical grade Oxygen(20%), Carbon Dioxide (5%) and balanced NitrogenNASA/ARC intends to purchase the modified Next Generation CCM and its subcomponents fromTissue Genesis, Inc. (TGI), a small business concern. TGI is composed of managers andengineers responsible for the CCM payload development and experimental flight series,totaling twenty-one successful Space Shuttle missions. This TGI core team includes theProgram Manager, Deputy Payload Manager, Senior Bioengineer and previous PrincipleInvestigators for the CCM series. The current TGI team was expanded to includeadditional bioengineering and biology expertise to successfully integrate and fly CCMexperiments 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 andperfusion systems and can modify existing technologies and hardware subcomponents inorder to meet the long duration research needs of the ISS. The TGI team of CCM payloadexperts is a uniquely capable provider of services owing to their extensive experienceand unique knowledge required to successfully develop and fly cell culture experimentswithin the CCM payload and ultimately integrate onto the ISS. The TGI facility containsin-house engineering and science research and development laboratories to conductbiological optimization and engineering development in parallel with cross-functionalproduct development awareness. There is no other company known with the CCM payloadoperational knowledge, CCM specific science integration expertise, cell biologymicro-gravitational operational understanding, and facilities to provide modification tothe 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 theeffort in writing (e-mail is preferred) to the identified point of contact not later than4:30 p.m. local time on 14 December 2011. Such capabilities/qualifications will beevaluated solely for the purpose of determining whether or not to conduct thisprocurement on a competitive basis. A determination by the Government not to competethis proposed effort on a full and open competition basis, based upon responses to thisnotice, 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 DeborahL. Feng, NASA Ames Research Center, Mail Stop: 200-9, Moffett Field, CA 95035-1000.