Notice Information
Notice Title
Genome Plasmid
Notice Description
We are planning a clinical trial to treat a rare genetic disease that causes progressive dementia in children. Our therapy is based on the following: Autologous haematopoietic stem progenitor cells (HSPCs) are modified ex vivo with a lentiviral vector (LV) to express supraphysiologic levels of a secreted enzyme in myeloid progeny, in essence using gene-modified monocytes/macrophages as a durable and effective vehicle for central nervous system (CNS) enzyme delivery. In order to progress this therapy, we require the following; a plasmid to our specification, produced to FDA, IND ready standard for use in the manufacture of a lentiviral vector for clinical trial. This Plasmid will be delivered directly from the supplier to the University of Edinburgh's partner in the project, University of California Los Angeles.
Lot Information
Lot 1
We are planning a clinical trial to treat a rare genetic disease that causes progressive dementia in children. Our therapy is based on the following: Autologous haematopoietic stem progenitor cells (HSPCs) are modified ex vivo with a lentiviral vector (LV) to express supraphysiologic levels of a secreted enzyme in myeloid progeny, in essence using gene-modified monocytes/macrophages as a durable and effective vehicle for central nervous system (CNS) enzyme delivery. In order to progress this therapy, we require the following; a plasmid to our specification, produced to FDA, IND ready standard for use in the manufacture of a lentiviral vector for clinical trial. This Plasmid will be delivered directly from the supplier to the University of Edinburgh's partner in the project, University of California Los Angeles. This will require the following QC to be performed: - Appearance - Clear, Colorless, No Visible Particulates upon visual inspection - A260:280 - 1.7-2.0 measured by Spectrophotometer - Concentration - 1.0 - 1.1 mg/ml (0.95-1.14mg/ml) measured by Spectrophotometer - Endotoxin - <30 EU/mg measured by Endosafe(r) PTS - DNA Homogeneity - >=90% All Supercoiled Forms analysed by Agarose Gel Electrophoresis - Residual RNA - None Detected @ 1.0mg load analysed by Agarose Gel Electrophoresis and Plasmid Safe(tm) Assay - Residual ssDNA - None Detected @ 1.0mg load analysed by Agarose Gel Electrophoresis and Plasmid Safe(tm) Assay - Residual Chromosomal DNA - None Detected @ 1.0mg load analysed by Agarose Gel Electrophoresis and Plasmid Safe(tm) Assay - Residual Linear DNA - <3% analysed by Plasmid Safe(tm) Assay and Linear DNA Assay - Identity - Consistent with Provided Information for 4 Restriction Reactions with no Discrepancies analysed by Restriction Digest and Research Primer Walking Sequencing - Protein - Reported measured by Micro BCA(tm) - pH of Final Product - 7.5-8.5 measured by pH meter - Bioburden - No growth on plates analysed by Five Day Bioburden The supplier must have previously supplied a plasmid to this specification that has been used in a similar clinical trial. The supplier must be able to evidence prior success in FDA approvals where their product has been used. The supplier will be required to deliver the product no later than 2 months after contract signature Supplied should follow all relevant legislation applicable to location of operation and State of California, USA
Options: To cover the potential for minor loss or extension of project scope the University may purchase additional orders from the winning supplier via the Negotiated Procedure Without Prior Call For Competition
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-r6ebe6-0000801998
- Publication Source
- Public Contracts Scotland
- Latest Notice
- https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=JUN532782
- Current Stage
- Tender
- All Stages
- Tender
Procurement Classification
- Notice Type
- PCS Notice - Website Contract Notice
- Procurement Type
- Standard
- Procurement Category
- Goods
- Procurement Method
- Open
- Procurement Method Details
- Open procedure
- Tender Suitability
- Not specified
- Awardee Scale
- Not specified
Common Procurement Vocabulary (CPV)
- CPV Divisions
33 - Medical equipments, pharmaceuticals and personal care products
-
- CPV Codes
33140000 - Medical consumables
Notice Value(s)
- Tender Value
- £62,000 Under £100K
- Lots Value
- Not specified
- Awards Value
- Not specified
- Contracts Value
- Not specified
Notice Dates
- Publication Date
- 17 Jun 20258 months ago
- Submission Deadline
- 1 Jul 2025Expired
- Future Notice Date
- Not specified
- Award Date
- Not specified
- Contract Period
- Not specified - Not specified
- Recurrence
- Not specified
Notice Status
- Tender Status
- Active
- Lots Status
- Active
- Awards Status
- Not Specified
- Contracts Status
- Not Specified
Buyer & Supplier
Contracting Authority (Buyer)
- Main Buyer
- UNIVERSITY OF EDINBURGH
- Contact Name
- Ross Sharp
- Contact Email
- rsharp4@ed.ac.uk
- Contact Phone
- +44 1316502759
Buyer Location
- Locality
- EDINBURGH
- Postcode
- EH1 1HT
- Post Town
- Edinburgh
- Country
- Scotland
-
- Major Region (ITL 1)
- TLM Scotland
- Basic Region (ITL 2)
- TLM1 East Central Scotland
- Small Region (ITL 3)
- TLM13 City of Edinburgh
- Delivery Location
- Not specified
-
- Local Authority
- City of Edinburgh
- Electoral Ward
- City Centre
- Westminster Constituency
- Edinburgh East and Musselburgh
Further Information
Notice Documents
-
https://www.publiccontractsscotland.gov.uk/search/show/search_view.aspx?ID=JUN532782
Genome Plasmid - We are planning a clinical trial to treat a rare genetic disease that causes progressive dementia in children. Our therapy is based on the following: Autologous haematopoietic stem progenitor cells (HSPCs) are modified ex vivo with a lentiviral vector (LV) to express supraphysiologic levels of a secreted enzyme in myeloid progeny, in essence using gene-modified monocytes/macrophages as a durable and effective vehicle for central nervous system (CNS) enzyme delivery. In order to progress this therapy, we require the following; a plasmid to our specification, produced to FDA, IND ready standard for use in the manufacture of a lentiviral vector for clinical trial. This Plasmid will be delivered directly from the supplier to the University of Edinburgh's partner in the project, University of California Los Angeles.
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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