SOURCES SOUGHT
Q -- Reprogramed iPSCs isolated from peripheral blood mononuclear cells of patients with MPD5
- Notice Date
- 6/9/2022 9:29:45 AM
- Notice Type
- Sources Sought
- 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
- 75N95022Q00295SS
- Response Due
- 6/17/2022 8:00:00 AM
- Point of Contact
- Morgen Slager, Phone: 3014020952
- E-Mail Address
-
morgen.slager@nih.gov
(morgen.slager@nih.gov)
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and (4) availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. For equipment/supply requirements, small business responses must include: (1) the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture), as well as (2) the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule). Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition.� It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract.� Responses will not be considered as proposals or quotes.� No award will be made as a result of this notice.� The Government will NOT be responsible for any costs incurred by the respondents to this notice.� This notice is strictly for research and information purposes only. This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition.� It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract.� Responses will not be considered as proposals or quotes.� No award will be made as a result of this notice.� The Government will NOT be responsible for any costs incurred by the respondents to this notice.� This notice is strictly for research and information purposes only. 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 and Objectives: Reprogramed iPSCs isolated from peripheral blood mononuclear cells of patients with MPD5 Project requirements: 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. 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. 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. Anticipated period of performance: 6 months ARO. Capability statement /information sought. Small business concerns that believe they possess the capabilities to provide the required product should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately.� Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Small businesses must also provide their Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. Interested small businesses are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. The respondent must also provide their Unique Entity ID from SAM.gov, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2� x 11� paper size, with 1� top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein.� A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit.� The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents� technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer.� Facsimile responses are NOT accepted. The response must be submitted to Morgen Slager, Contract Specialist at e-mail address morgen.slager@nih.gov. �� The response must be received on or before Friday June 17, 2022, 11am, Eastern Time. �Disclaimer and Important Notes:� This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization�s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).�
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-
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- Record
- SN06353849-F 20220611/220609230109 (samdaily.us)
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-
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