Notice Information
Notice Title
OECD 488 transgenic rodent mutation assay (TGRA) using the Big Blue(r) rat
Notice Description
The conduct of an OECD 488 transgenic rodent mutation assay (TGRA) using the Big Blue(r) rat using cII mutant selection for the University of Sheffield. Studies will be conducted to GLP, and are based on the following preliminary study design: 1. Breeding of target cohort of 46 Big Blue male rats, with delivery of a target of 44 rats to Charles River Laboratories (CRL) facility, Ashland Ohio, USA. 2. Transfer of HPLC analytical method for dose formulation analysis (DFA) and method transfer summary performed by CRL. 3. Method validation, homogeneity, solubility and stability work to enable GLP doseformulation analysis during Big Blue(r) TGRA main study, performed by CRL. 4. 7-day dose-range finding study (DRF), wild type Fischer F344 male and female rats, to determine limit dose of 1000 mg / kg body weight /day or MTD, performed by CRL. 5. Big Blue(r) TGRA rat main study, male only, using vehicle, 3 dose groups and concurrent positive control conducted at CRL. Each group will contain at least 6 male rats, conducted in accordance with OECD 488; daily test item administration by oral gavage for 28 days (positive control will be dosed days 1, 3, 10, 17 & 24 only); termination and schedule necropsy on day 31 with duodenum, liver and bone marrow removed from all animals, flash frozen and stored prior to shipment to Gentronix. 6. Pig-A in vivo mutation analysis will be integrated into the Big Blue(r) TGRA study, with all study animals screened for elevated Pig-A locus mutation in the pre-study acclimatisation phase, and then a blood sample taken from all animals on study on day 31 as a terminal bleed to minimise animal handling procedures and impact onto the Big Blue(r) TGRA study. 7. Dose formulation analysis during conduct of the main study, performed by CRL. 8. Analysis of liver and duodenum (bone marrow will not be analysed initially) from 5 animals per dose group in the in vitro phase of the Big Blue(r) TGRA study as per OECD 488 will be conducted at and performed by Gentronix. DNA will be extracted, packaged into lambda bacteriophage used to infect E. coli strain G1250 to determine phage packaging efficiency and cII mutation detection after plating on agar. Phage packaging titres of at least 125,000 per animal will be determined, to facilitate estimation of mutation frequency. 9. GLP reporting of results. F15: Voluntary ex ante transparency notice (2022/S 000-006619) and F03: Contract award notice (2022/S 000-014913) relate
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-b5fd17-e9b8c27c-841f-489e-b7d8-3406bcad23b8
- Publication Source
- Contracts Finder
- Latest Notice
- https://www.contractsfinder.service.gov.uk/Notice/8742fb2f-ea5a-4f40-bfc9-ef9633e27715
- Current Stage
- Award
- All Stages
- Award
Procurement Classification
- Notice Type
- Award Notice
- Procurement Type
- Standard
- Procurement Category
- Services
- Procurement Method
- Limited
- Procurement Method Details
- Negotiated procedure without prior publication (above threshold)
- Tender Suitability
- SME
- Awardee Scale
- SME
Common Procurement Vocabulary (CPV)
- CPV Divisions
73 - Research and development services and related consultancy services
-
- CPV Codes
73111000 - Research laboratory services
Notice Value(s)
- Tender Value
- £366,300 £100K-£500K
- Lots Value
- Not specified
- Awards Value
- £366,300 £100K-£500K
- Contracts Value
- Not specified
Notice Dates
- Publication Date
- 27 May 20223 years ago
- Submission Deadline
- 13 May 2022Expired
- Future Notice Date
- Not specified
- Award Date
- 12 May 20223 years ago
- Contract Period
- 13 May 2022 - 31 May 2023 1-2 years
- Recurrence
- Not specified
Notice Status
- Tender Status
- Complete
- Lots Status
- Not Specified
- Awards Status
- Active
- Contracts Status
- Not Specified
Buyer & Supplier
Contracting Authority (Buyer)
- Main Buyer
- UNIVERSITY OF SHEFFIELD
- Contact Name
- Jamie Shaw
- Contact Email
- jamie.shaw@sheffield.ac.uk
- Contact Phone
- 01142221516
Buyer Location
- Locality
- SHEFFIELD
- Postcode
- S10 2TN
- Post Town
- Sheffield
- Country
- England
-
- Major Region (ITL 1)
- TLE Yorkshire and The Humber
- Basic Region (ITL 2)
- TLE3 South Yorkshire
- Small Region (ITL 3)
- TLE32 Sheffield
- Delivery Location
- TLE Yorkshire and The Humber
-
- Local Authority
- Sheffield
- Electoral Ward
- Broomhill and Sharrow Vale
- Westminster Constituency
- Sheffield Central
Further Information
Notice Documents
-
https://www.contractsfinder.service.gov.uk/Notice/8742fb2f-ea5a-4f40-bfc9-ef9633e27715
27th May 2022 - Awarded contract notice on Contracts Finder
Open Contracting Data Standard (OCDS)
View full OCDS Record for this contracting process
The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.
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