Framework for QC Outsource Testing

Concepts

• redcar
• analysis services
• national biologics manufacturing centre
• qc outsource testing
• multi supplier framework agreement
• routine testing
• analytical testing services
• period of the framework
• qc release testing of nucleic acid therapeutics
• cpi centre

Location

Redcar

Description

CPI has a requirement, which will to be to establish a Multi Supplier Framework agreement for the QC outsource testing initially at our National Biologics Manufacturing Centre, but services may be extended across other CPI Centre’s as and when required throughout the period of the Framework. The Tender is split into two Lots. Lot 1 - Routine Testing/Monitoring of Samples. Lot 2 - GMP Analytical Testing Services

Total Quantity or Scope

GMP analytical testing services are required for QC release testing of nucleic acid therapeutics including mRNA Active Pharmaceutical Ingredient (API) and lipid nanoparticle containing mRNA Bulk Drug Substance (BDS).

Award Detail

Award Criteria

CPV Codes

• 71620000 - Analysis services

Indicators

• Award on basis of price and quality.

Legal Justification

*The COVID-19 outbreak has given rise to an urgent need for GMP analytical testing services required for QC release testing of nucleic acid therapeutics including mRNA Active Pharmaceutical Ingredient (API) and lipid nanoparticle containing mRNA Bulk Drug Substance (BDS). because of an urgent need to respond and develop a vaccine. This does not give CPI sufficient time to comply with the standard open procedure timescales for this procurement. CPI considers this to be a state of urgency which it has duly substantiated. Accordingly, CPI is using the accelerated time limits permitted under the Public Contract Regulations 2015 (regulation [27(5) for the open procedure) in respect of this procurement

Other Information

Upon successful award, the requirements of this Tender can be procured by any department, branch, division, business unit, site, subsidiary or any other legal entity of CPI, against any existing or future project and/or order, whether or not it is part funded by the European Regional Development Fund (ERDF) Competitive Programme 2014 – 2020, or any subsequent replacement Competitive Programme (SC Ref:682341)