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FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 12, 2014 FBO #4675
SOLICITATION NOTICE

Q -- Production and Purification of Various GalNAc-T Isoforms

Notice Date
9/10/2014
 
Notice Type
Combined Synopsis/Solicitation
 
NAICS
541711 — Research and Development in Biotechnology
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
 
ZIP Code
20892-7902
 
Solicitation Number
HHS-NIH-NHLBI-CSB-DE-2014-262-KEW
 
Archive Date
10/2/2014
 
Point of Contact
Kyle Wisor, Phone: 3014023670, Rashida Ferebee,
 
E-Mail Address
Kyle.Wisor@nih.gov,
(Kyle.Wisor@nih.gov, ontracting)
 
Small Business Set-Aside
N/A
 
Description
(1) Action Code: Combined Synopsis/Solicitation (2) Date: September 8th (3) Year: 2014 (4) Contracting Office Zip Code: 20892 (5) Classification Code: Q301 (6) Contracting Office Address: 6701 Rockledge Drive Rockledge II Bethesda, MD 20892 (7) Subject/Title: Production and Purification of Various GalNAc-T Isoforms (8) Proposed Solicitation Number: HHS-NIH-NHLBI-CSB-DE-2014-262-KEW (9) Closing Response Date: September 17th, 2014 (10) Contact Point: Kyle Wisor, Contract Specialist (11) Contract Award and Solicitation Number: TBD (12) Contract Award Dollar Amount: UKN (13) Contract Line Item Number(s): TBD (14) Contractor Award Date: TBD (15) Contractor Name: TBD (16) Description: Production and purification of GalNAc-T Isoforms (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 HHS-NIH-NHLBI-CSB-DE-2014-262-KEW and the solicitation is issued as an request for proposal (RFP). (iii) The solicitation document, the incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-76 effective 25 AUG 2014. (iv) The associated NAICS code is 541711 Research and Development in biotechnology and the small business size standard is 500 employees. The acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13. (v) The Contractor Shall: I. Provide low mg quantities of wild type GalNAc-T2, GalNAc-T2D314A, GalNAc-T15, GalNAc-T17, GalNac-T18 and pGANT4 by following the protocol described below in II. II. Expression/Purification of first two (2) constructs from existing vectors (wt and mutant GalNAc-T2's), completion. a. DNA preparation. 1. The contractor will receive 100 ng of each of the 2 expression vectors. The contractor will take care of E. coli transformations/plasmid preparations, sequence verification across ORF and cloning junctions, and make glycerol stocks. b. Yeast Transformation and initial expression testing. 1. Starting with 2 µg of each plasmid (from a.1), The Contractor will prep the DNA, transform and create the Pichia strains, induce expression of at least 6 clones/strain, run an initial SDS-PAGE/Ruby stain, and send the majority of the supernatant from each sample to the Tabak's Lab for verification of activity. c. Small scale induction and purification of 2 selected clones, based on results from Tabak's lab testing. 1. Induction: For example, 100 ml cultures, 3 time-points to determine optimal harvest time (samples sent to Tabak's Lab/NIH for analysis after this step). 2. Purification: Small-scale purification trials on pooled supernatant, test of purification scheme to determine yields and develop a process for larger volumes. Importantly, this is with a His-Tag, as in JBC, MARCH 31, 2006•VOLUME 281•NUMBER 13. d. Production: Induce 2 liters of culture (generate cell mass on glycerol, shift to MeOH and harvest at planned time based on literature and or step c). Remove cells from supernatant (freeze supernatant for storage until purification). e. Purification: His-tag purification of protein from 2 liters of induced supernatant, as worked out in step c, similar to published purification scheme with the goal of generating 5 - 10 mg of purified protein. This includes the removal of the His tag by TEV protease. Deliverables include: report and recommendations (after steps b, c, and e), protein and any plasmids, strains and other reagents created during the project III. Expression/Purification of four (4) additional (similar) proteins a. Gene/system design: vector construction (start from amino acid sequence provided by customer). Optimize nucleotide sequence, have genes synthesized and sub-clone the DNA into expression vectors. Includes sequence verification of entire ORF and cloning junctions. b. Strain construction and expression testing: Preparation of DNA, transform/select/characterize clones, expression test/MeOH induction, run initial SDS/PAGE and send supernatant to Tabak's Lab/NIH. c. Expression and Purification of protein from the 4 different ORF's targeted in this section. 1. Induce 2 liters of each select clone in shake flask culture, harvest by removing cells and freezing supernatant. 2. Purification, as with the proteins in Part II above. Includes initial process testing/optimization on ~100 ml of the supernatant. Deliverables include: report and recommendations (after steps a, b, and c), protein and any plasmids, strains and other reagents created during the project (vi) Period of Performance is from 9/26/14 - 3/26/15; II & III can be performed parallel a. II a/b: complete 3-4 weeks b. II c: complete 3-4 weeks c. II d: complete 1 week d. II e: complete 2.5 weeks e. III a: complete 4 weeks f. III b: complete 3-4 weeks g. III c: complete 3-4 weeks Location of delivery is: ATTN: Raul Rojas National Institutes of Health, NIDCR 9000 Rockville Pike Building 30, Room 524 Bethesda, MD 20892 (viii) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. (ix) The provision at FAR clause 52.212-2, Evaluation - Commercial Items, is applicable. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, best value and other factors considered. The Government will evaluate quotations based on the following evaluation criteria: Technical Capability and Best Value. 1. Technical Evaluation (60 points) i. Ability to express these human N and O-glycosylated proteins in yeast strains with "humanize" glycosylation pathways to improve protein stability and activity. (30 points) ii. Ability to use different cloning vectors that can provide a variety of promoters and secretion signals for expression testing. Ideally, the cloning scheme to move genes from vector to vector should be seamless to allow easy and fast cloning. (30 points) 2. Best value to the Government (30 points) (x) FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision. (xi) FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. (xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. Including the following clauses: i. 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (AUG 2011) ii. 52.225-13, Restrictions on Certain Foreign Purchases iii. 52.244-6, Subcontracts for Commercial Items iv. 52.2232-39, Unenforceability of Unauthorized Obligations (xiii) Additional Contract Requirements: Progress reports will be sent to Dr. Raul Rojas, a staff scientist in the Section on Biological Chemistry (Tabak Lab). As specified in previous sections, there will be various steps to assess the progress and quality of the reagents being produced. The Contractor will test the levels of expression and stability of the protein and the Tabak Lab will test their activity. The Tabak Lab expects the first report to arrive 4 weeks after the initiation of part II, step b of the project. If the results are satisfactory, step II.c (small scale production) will be initiated and another report submitted after 4 weeks. If the results are satisfactory, steps II.d and II.e will start and a final report, describing the results of part II will be deliver 4 weeks after. Reports for part III will need to be delivered in a time scheme similar to the one described for part II. Once step III.b is initiated, a report should be sent 4 weeks after. Like in part II, the initiation of steps subsequent to step III.b will depend on the expression levels and optimal activity of the proteins based on the quality control assays run by the Contractor and by the Tabak Lab as described in part II.b. (xiv) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable. (xv) All responses must be received by September 17th, 2014 at 9:00 AM and must reference number HHS-NIH-NHLBI-CSB-DE-2014-262-KEW. Responses may be submitted electronically to Kyle.Wisor@nih.gov or by U.S. mail to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Suite 6150B, Bethesda, MD 20892-7902, Attention: Kyle Wisor. Phone: 301-402-3670; Fax responses will not be accepted (17) Place of Contract Performance: National Institutes of Health, NIDCR 9000 Rockville Pike Building 30, Room 524 Bethesda, MD 20892 (18) Set-aside Status: None
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-DE-2014-262-KEW/listing.html)
 
Place of Performance
Address: 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
Zip Code: 20892
 
Record
SN03505395-W 20140912/140911000147-6866ac55ea50021e1447dc24ce538d85 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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