Establishing Organ Chip Models For Studying Radiation Induced Normal Tissue Injury And Identifying Rna Biomarkers For Radiation Biodosimetry

Title Establishing Organ Chip Models For Studying Radiation Induced Normal Tissue Injury And Identifying Rna Biomarkers For Radiation Biodosimetry Document Type Special Notice Solicitation Number 75N91020r00010 1 Posted Date 04 06 2020 Response Date 04 16 2020 Classification Code 6505 Biological And Reagent Material Direct Use Naics Code 334517 Irradiation Apparatus Manufacturing 1000 Employees Contracting Office Address Department Of Health And Human Services National Institutes Of Health National Cancer Institute Office Of Acquisitions 9609 Medical Center Drive Room 1E128 Bethesda Md 20892 United States The Dhhs Nih National Cancer Institute Nci Center For Cancer Research Ccr Radiation Oncology Branch Rob Plans To Procure On A Sole Source Basis Organ Chip Models For Studying Radiation Induced Normal Tissue Injury And Identifying Rna Biomarkers For Radiation Biodosimetry From Emulate Inc Lls 27 Drydock Ave 5Th Floor Boston Ma 02210 The Response Close Date Of This Notice For This Requirement Is In Accordance With Far 5 203 A 1 This Acquisition Will Be Processed Under Far Part 12 Acquisition For Commercial Items And Will Be Made Pursuant To The Authority In Far 13 106 1 B 1 Using Simplified Acquisition Procedures For Commercial Acquisitions And Is Exempt From The Requirements Of Far Part 6 The North American Industry Classification System Code Is 334517 Irradiation Apparatus Manufacturing 1000 Employees This Will Be Awarded As A Severable Firm Fixed Price Type Contract The Award Will Be In The Aggregate It Has Been Determined There Are No Opportunities To Acquire Green Products Or Services For This Procurement Background Partial Or Total Body Irradiation Tbi Causes Damage To The Vascular Endothelium And In Effect Injury To Vital Organs Such As The Lungs Liver Kidneys Heart And Brain Current Models For Studying Acute Radiation Injury And Its Biomarkers Include Animal Models E G Mouse Non Human Primate And Static In Vitro Cell Cultures Mice Are The Most Frequently Used Animal Models Because They Ve Been Well Characterized And Are Advantageous In Terms Of Space Time And Cost However They Do Not Mimic Human Physiology Or Organ Structure And Fail To Recapitulate All Radiation Responses Observed In Humans By Contrast Two And Three Dimensional In Vitro Cell Cultures Address The Human Aspect That Animal Models Lack But Do Not Mimic Cell Behavior In The Body And Thus Sacrifice Key Biological Interactions Required To Understand The Molecular Mechanisms Of Radiation Response The Dhhs Nih National Cancer Institute Nci Center For Cancer Research Ccr Radiation Oncology Branch Rob Recently Conducted Extensive Research In A Mouse Model After Whole Body Irradiation To See If Non Coding Rnas And Coding Rnas Can Be Used As Biomarkers For Radiation Biodosimetry The Nci Has Also Been Assessing The Role Of The Radiation Induced Mirnas In Prostate Carcinoma Cells Normal Prostate Epithelial Cells Rwpe 1 And In Human Coronary Artery Endothelial Cells Hcaec As Potential Molecular Therapeutic Targets In Radiotherapy To Bridge The Gap Between Our Previously Studied Animal Models And Static In Vitro Cell Cultures An Automated Microfluidic Cell Culture System Of Human Organ Chips Is Necessary This System Will Incorporate Mechanical Stretch Of And Continuous Fluid Flow Through The Organ Chips To Recreate The Tissue Tissue Interfaces Of Human Organs Previous Work Demonstrates Not Only That Organ Chips Grown In This Automated Culture System Mimic The Microenvironment Structure And Cellular Interactions Of Human Organs But That Irradiating The Organ Chips Leads To The Same Structural Damage Seen In Humans After Radiation By Recapitulating Key Radiation Induced Responses Seen In Humans The Automated Organ Chip Culture System Provides A More Advance In Vitro Model For Studying Radiation Induced Normal Tissue Injury And Identifying Radiation Induced Rna Biomarkers Special Order Requirementsproduct Features Salient Characteristics The Nci S Organ Chip Platform Must Meet The Following Criteria 1 The Cell Culture System Must Contain Microfluidic Chips Made From Silicone Polymer With A 7 m Membrane Separating The Endothelial And Epithelial Chambers This Allows The Culture To Be Subject To Specific Mechanical Forces I E Fluid Flow And Stretch That Recapitulate The Microenvironment Of Cells In The Human Body Additionally Separate Endothelial And Epithelial Chambers Allow Isolation Of Each Cell Type Independently Of The Other Which Is Critical To Study Response Of The Endothelium To Radiation And Observe Its Interactions With Other Key Cell Types Such As Organ Specific Epithelial Cells 2 The Chips Should Also Be Available In Forms Suitable For Culture Of Various Organ Specific Cells Basic Research And Liver Co Culture Kits The Chips Should Connect To A Holder Pod That Enables The Addition And Replenishment Of Fluid To The Epithelial And Endothelial Chambers Independently Without The Need For Peristaltic Pumps Tubing Or Syringes The Flow And Stretch Applied To The Chip Pod System Should Range From 0 l Hr 1000 l Hr And 0 01Hz To Max 0 4Hz Or A Maximum Of 10 Respectively These Conditions Should Be User Selectable Through A Digital Interface 3 The Chips Should Reside In The Pod And Be Placed Inside A Controlling Instrument Culture Module That Holds 12 Chips And Is Able To Be Housed In An Incubator This Incubator Should Be Pre Programmed By The User To Enable Treatment And Culture Of The Cells In The Epithelial And Endothelial Chambers Independently 4 The System Should Be Designed So That Individual Chip Pod Systems Can Be Removed From The Culture Module Analyzed With Live Cell Imaging Via A Microscope And Placed Back Into The Culture Module Within The Incubator Furthermore This Removal Of The Chip Pod System From The Culture Module Should Be Easy And The Pod Should Contain 4 Fluid Reservoirs 2 For The Endothelial And Epithelial Inlet Chambers And 2 For The Outlet Flow From Each Chamber This Will Enable Collection Of Effluent From The Chip At Any Time While It Is In The Incubator 5 The Instruments That Supply Power And Forces To The Chip Pod Systems Culture And Power Modules Should Do So Via Internal Pressure Thus Eliminating The Need For A Pumping System A System With The Aforementioned Specifications Is Necessary For Reproducibility Of Experiments For Compatibility With Downstream Analysis Instruments E G Imagers And To Fit Within The Dimensions Of The Current Incubator And Lab Space Each Component Of The System Must Have The Following Key Specifications Culture Module System Controls Flow In The Organ Chip Min 0Ul Hr To Max 1000Ul Hr System Controls Stretch Frequency Min 0 01Hz To Max 0 4Hz System Has A Maximum Organ Chip Stretch 10 System Controls Flow Of Up To 12 Organ Chips Independently System Operating Temperature 20 37 5 C Power Source Connects And Supplies Power To Up To Two Culture Modules Provides Gas Power And Stretch Required By Culture Modules Organ Chips Organ Chip Contains Epithelial Chamber And Endothelial Chamber Separated By 7Um Flexible Membrane Organ Chip Is High Clarity Amp Optically Transparent To Allow High Content Imaging Organ Chip Holder Known As A Pod Contains 2 Reservoirs For Inlet And 2 Reservoirs For Collection Off Effluent Pods And Organ Chips Are Self Contained With 0 2Um Filters To Ensure No Cross Contamination While In Instrument Pods And Organ Chips Are Supplied Sterile For Cell Culture The Core Strength And Sole Focus Of Emulate Inc Is The Development And Sale Of Microfluidic Cell Culture Systems That Recapitulate The Biology And Physiology Of Human Organs Organ Chips Emulate Is The Sole Known Source For A Culture System That Meets The Aforementioned Requirements And Specifications This Notice Is Not A Request For Competitive Quotation However If Any Interested Party Especially Small Businesses Believes It Can Meet The Above Requirement It May Submit A Capability Statement Proposal Or Quotation Which Shall Be Considered By The Agency The Statement Of Capabilities And Any Other Information Furnished Must Be In Writing And Must Contain Material In Sufficient Detail To Allow The Nci To Determine If The Party Can Perform The Requirement Responses Must Be Received In The Contracting Office By 3 00Pm Edt On April 16 2020 All Responses And Questions Must Be In Writing And Faxed 240 276 5433 Or Emailed To William Neal Contracting Officer Via Electronic Mail At William Neal Nih Gov A Determination By The Government Not To Compete This Proposed Requirement Based Upon Responses To This Notice Is Solely Within The Discretion Of The Government Information Received Will Be Considered Solely For The Purpose Of Determining Whether To Conduct A Competitive Procurement No Collect Calls Will Be Accepted In Order To Receive An Award Contractors Must Be Registered And Have Valid Current Entity Record Including Current Representations And Certifications In The System For Award Management Sam Through Sam Gov Reference 75N91020r00010 1 On 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