MODIFICATION
Q -- Reprogramed iPSCs isolated from peripheral blood mononuclear cells of patients with MPD5
- Notice Date
- 6/23/2022 3:44:55 PM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95022Q00295CSS
- Response Due
- 7/1/2022 8:00:00 AM
- Archive Date
- 07/16/2022
- Point of Contact
- Morgen Slager, Phone: 3014020952
- E-Mail Address
-
morgen.slager@nih.gov
(morgen.slager@nih.gov)
- Description
- (i)� � This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii)� �The solicitation number is 75N95022Q00295CSS and the solicitation is issued as a for proposal (RFP). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13�Simplified Acquisition Procedures; and FAR Part 12�Acquisition of Commercial Items and is not expected to exceed the simplified acquisition threshold. (iii)� The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2022-06 dated May 26, 2022. (iv)� The associated NAICS code is 541990, All Other Professional, Scientific and Technical Services (v)� �This requirement is for Reprogramed iPSCs isolated from peripheral blood mononuclear cells of patients with MPD5. (vi)��Background: The NCATS Early Translation Branch (ETB) collaborates with investigators at NIH and in the academic, biopharmaceutical and nonprofit sectors to generate probes for studying a diverse cross-section of human biology, focusing specifically on new targets and untreatable diseases. One of such untreatable diseases is Distal 5 Myopathy (MPD5) caused by mutation in ADSSL1 gene. This is an ultra-rare disease which we could not be found on the National Organization for Rare Disorders (NORD) or any other rare disease databases. It causes a rapid onset of progression on the spam of two years. It makes patients challenging to climb stairs along with increasing difficulty with activities like getting up from a chair. His walking, foot drop due to which they sometimes trip, they have difficulty swallowing, and experience shortness of breath while walking. They also have dysphagia with masticatory dysfunction, proximal muscle weakness, distal muscle weakness, heart muscle disease, reduced lung volume, muscle wasting (dystrophic changes), muscle cell death (necrotizing skeletal myopathy), rimmed vacuoles, Drooping eyelids (bilateral ptosis), dry eyes (keratoconjunctivitis sicca), facial muscle weakness (facial palsy), involuntary tight closure of the eyelids (blepharospasm), abnormal scarring (atrophic scars), stiff elbow joints (elbow flexion contracture), loss of ambulation This genetic mutation adversely impacts the conversion of IMP to AMP in the Purine Nucleotide Cycle. The goal is to conduct drug repurposing studies for MPD5 given that this myopathy results from impact on metabolic pathways. This requisition is to study further the biology of the mutation, which will help us develop compound screening campaigns. Purpose: Reprogramed iPSCs isolated from peripheral blood mononuclear cells of patients with MPD5 Project Requirements: In accordance with the attached Statement of Work (SOW) and the below requirments: 1. Summary of Work.� For the whole blood sample designated by ETB for reprogramming expansion, contractor will isolate peripheral blood mononuclear cells (PBMCs) and reprogram these cells into iPSCs as directed by the ETB.� Initially, a Master Cell Bank (MCB) of one clone with at least three (3) vials will be created per PBMC submitted and stored. Upon the successful creation of the MCB, two (2) vials will be shipped to ETB-specified collaborator location. One (1) additional vial of the MCB will be donated (submitted) to the National Institute for General Medical Sciences Human Genetic Cell Repository (NIGMS HGCR). These iPSCs will be subject to all regulations and terms of a submission to the NIGMS HGCR. 2. Master Cell Bank - Generation and Quality Control MCB Deemed Successful.� The MCB generation (expansion) will be deemed ""successful"" in respect of a iPSC line if (a) the number of vials of cells of such iPSC line specified above has been generated and (b) passed each MCB QC Test .� In the event of a QC Test failure, another vial from the frozen MCB will be used to repeat the QC Test. Master Cell Bank Quality Control Tests.� As part of MCB creation activities contractor will perform the following QC Tests: SeV Genome RT-PCR: SeV Genome assay is a RT-PCR assay with SeV genome sequence and transgene-specific primers that allows specific detection of transgenes carried by CytoTune 2.0 Sendai Virus reprogramming vectors to confirm loss of expression of Sendai genome and transgenes.� Viability: Viability is determined by measuring the area of five (5) colonies at first appearance (Day 1), then again within five (5) days. Colony doubling within five (5) days of the first appearance signifies a viable culture. Growth Rate: The MCB will be assessed for growth rate through colony doubling within five (5) days of first colony appearance. Mycoplasma: a sample of the MCB will be tested for mycoplasma using the MycoSEQ� Mycoplasma Detection Kit from ThermoFisher Scientific. This real-time PCR assay detects of >90 mycoplasma species with proven specificity and demonstrated sensitivity (detecting <10 copies per reaction). 6-Plex Short Tandem Repeat (STR): A sample of the MCB will undergo STR/identity analysis using Coriell�s 6-plex microsatellite assay. This is a short tandem repeat (STR) multiplex PCR assay. This single reaction amplifies six (6) tetranucleotide repeat loci and amelogenin, the gender-determination marker. Karyotyping: Twenty (20) metaphases will be counted; of these at least five (5) cells will be analyzed and examined microscopically for numerical and structural abnormalities. At least five (5) cells will be karyotyped. Results include International System for Human Cytogenetic Nomenclature (ISCN) results with at least two (2) images of G-banded karyograms. Harvested cell pellets will be kept until ETB accepts the MCB, slides with dropped metaphases for analysis will be kept for one month, and copies of the digital records will be available for three (3) years after the creation of such record. Contractor�s criteria for failure of karyotype testing shall be defined by any of the following results: Of the initial twenty (20) cells that are counted and five (5) cells that are analyzed, if three (3) of the analyzed cells show the same abnormality, then ten (10) additional cells will be assessed. If one (1) more cell, for a total of 4 analyzed cells, contains the same abnormality, then the line is deemed abnormal. If contractor deems an iPSC line to have failed Karyotyping, ETB shall have the option to request an additional karyotyping QC test at an additional cost.� The parties agree to discuss in good faith any karyotyping QC issues and any potential resolution prior to an iPSC line to be deemed to have failed Karyotyping. If a certain abnormality was found in a previous study (parent line, sister line, or expansion), the line fails. If the total non-clonal abnormalities ?25%, the line fails. SNP 6.0 Genotyping: a MCB sample will be analyzed using the Affymetrix Genome-Wide Human SNP Array 6.0 (SNP CGH Array) in CORIELL's genotyping center. Upon detection of cytogenomic abnormalities, lines will fail at the discretion of the cytogenomics consultant. Embryoid Body (EB) Formation from Undifferentiated Cells and RT-PCR to confirm trilineage differentiation potential: EB formation assay will be conducted using undifferentiated iPS cells and it will be followed for ten (10) days in culture. After ten (10) days, embryoid bodies (EBs) will be harvested followed by RNA extraction, cDNA synthesis, and RT-PCR assay to detect the expression of genes in all three (3) germ layers. Expression of at least one gene per germ layer is required for confirming pluripotency.� Alkaline Phosphatase (AP): Staining will be conducted using the StemTAG Alkaline Phosphatase Staining kit from Cell Biolabs to confirm that the culture is within the desired limit of undifferentiated stem cells as a high level of AP and high AP activity are traditional markers of pluripotent stem cells. Cell Surface Antigen Expression: Analysis will be conducted by flow cytometry using SSEA 3 and SSEA 4 staining.� Flow cytometry is also performed if an abnormal morphology is observed throughout the culturing process in order to confirm that the culture is within the desired limit of undifferentiated iPS cells. 3. Storage, Distribution, and Destruction of MCB.� Two (2) vials of successfully established MCB vials will be shipped to ETB or ETB-desired recipient upon completion.� Deliverables: Contractor shall deliver with in six (6) months ARO: Two (2) vials of reprogramed iPSCs isolated from peripheral blood mononuclear cells (PBMCs) One (1) additional vial of the MCB will be donated (submitted) to the National Institute for General Medical Sciences Human Genetic Cell Repository (NIGMS HGCR). These iPSCs will be subject to all regulations and terms of a submission to the NIGMS HGCR. Reporting Requirements: iPSCs quality control assessments/tests Government Responsibilities: The NCATS Early Translation Branch (ETB) and its collaborators will provide vendor with whole blood sample designated for reprogramming expansion. (vii)��Period of Performance: 6 months ARO The Government anticipates award of a Firm-Fixed Price contract for this acquisition, and the anticipated period of performance is July 18, 2022 through January 18, 2023, six (6) �months after award. (viii)� The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:� https://www.acquisition.gov/browse/index/far �� https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html �� � (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.212-1, Instructions to Offerors-Commercial Items (Nov 2021) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021) FAR 52.225-2, Buy American Certificate (Feb 2021) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text.� Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (Jan 2022) NIH Invoice and Payment Provisions (Feb 2021) (ix)� �The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: a. Technical capability of the item offered to meet the Government requirement; b. Price; and c. Past performance [see FAR 13.106-2(b)(3)].� (x)� �The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. (xi)� �The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xii)��The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiii)� �The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiv)� Responses to this solicitation must include sufficient information to establish the interested parties� bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include: past performance, special features required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, and environmental and energy efficiency considerations. Responses to this solicitation must include clear and convincing evidence of the offeror�s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. The Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All offers must be received by 11:00 a.m., Eastern Daylight/Standard Time, on Friday, July 1, 2022, and reference Solicitation Number 75N95022Q00295CSS. Responses must be submitted electronically to Morgen Slager, Contract Specialist at morgen.slager@nih.gov. Fax responses will not be accepted.
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- SN06366409-F 20220625/220623230117 (samdaily.us)
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