Published date: 27 May 2022
Awarded contract - This means that the contract has been awarded to a supplier.
Contract summary
Industry
Research laboratory services - 73111000
Location of contract
Yorkshire and the Humber
Value of contract
£366,300
Procurement reference
3351/SSA/JS
Published date
27 May 2022
Closing date
13 May 2022
Closing time
5pm
Contract start date
14 May 2022
Contract end date
31 May 2023
Contract type
Service contract
Procedure type
Negotiated procedure without prior publication (above threshold)
The opportunity was not advertised, because for example only one supplier is capable of delivering the requirement, or due to extreme urgency brought about by unforeseen events.
This procedure can be used for procurements above the relevant contract value threshold.
Contract is suitable for SMEs?
Yes
Contract is suitable for VCSEs?
No
Description
The conduct of an OECD 488 transgenic rodent mutation assay (TGRA) using the Big Blue® 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® 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® 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® 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® 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® 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
Award information
Awarded date
13 May 2022
Contract start date
14 May 2022
Contract end date
31 May 2023
Total value of contract
£366,300
This contract was awarded to 1 supplier.
GENTRONIX LIMITED
Address
Alderley Park
Cheshire East
M13 9NT
GBReference
Companies House number: 03810162
Supplier is SME?
Yes
Supplier is VCSE?
No
About the buyer
Contact name
Jamie Shaw
Address
Western Bank
SHEFFIELD
S102TN
England
Telephone
01142221516
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Closing: 13 May 2022, 5pm
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