Section one: Contracting authority
one.1) Name and addresses
NHS Blood and Transplant
500 North Bristol Park
Bristol
BS34 7QH
Contact
Richard Athay-Hunt
richard.athay-hunt@nhsbt.nhs.uk
Country
United Kingdom
Region code
UKK11 - Bristol, City of
Internet address(es)
Main address
Buyer's address
one.3) Communication
Additional information can be obtained from the above-mentioned address
Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at
https://health-family.force.com/s/Welcome
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Qualified Person Service for Investigational Medicinal Product (IMP)
Reference number
C197288
two.1.2) Main CPV code
- 73100000 - Research and experimental development services
two.1.3) Type of contract
Services
two.1.4) Short description
NHSBT are looking to appoint a suitable Qualified Person (QP) on a contract basis to work alongside its existing in-house QPs to support a very active and rapidly growing portfolio of Investigational Medicinal Product (IMP) manufacturing projects.
two.1.5) Estimated total value
Value excluding VAT: £260,000
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.3) Place of performance
NUTS codes
- UKK1 - Gloucestershire, Wiltshire and Bristol/Bath area
two.2.4) Description of the procurement
NHSBT are looking to appoint a suitable Qualified Person (QP) on a contract basis to work alongside its existing in-house QPs to support a very active and rapidly growing portfolio of Investigational Medicinal Product (IMP) manufacturing projects.
NHSBT has developed the capability over at least 20 years to manufacture a range of Biotechnology, Gene Therapy, Cell Therapy and Tissue Engineered Medicinal Products for Phase I/II clinical Trials. Many of these are categorised as Advanced Therapy Medicinal Products (ATMP) in accordance with EU Regulations. IMP manufacture is focused at NHSBT facilities in Barnsley, Bristol, Birmingham, and Liverpool holding appropriate MIA(IMP). NHSBT manufacture IMP for both internally sponsored Clinical Trials and under contract for academic and commercial clients.
The services we require the Qualified Person (QP) to support are as follows:
· Advice on regulatory and quality compliance requirements for specific Biological and ATMP manufacturing projects.
· Input to selected regulatory submissions
· Input to design of selected processes and facilities
· QP Certification of batches of biological & ATMP for use in approved clinical trials
· Mentoring of selected NHSBT staff through the process of obtaining QP registration
two.3) Estimated date of publication of contract notice
20 September 2023
Section four. Procedure
four.1) Description
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: No