Published date: 1 August 2019

Closed opportunity - This means that the contract is currently closed. The buying department may be considering suppliers that have already applied, or no suitable offers were made.


Closing: 2 September 2019

Contract summary

Industry

  • Laboratory services - 71900000

Location of contract

BS34 7QH

Value of contract

£0

Procurement reference

tender_214910/786134

Published date

1 August 2019

Closing date

2 September 2019

Contract start date

1 January 2020

Contract end date

31 December 2024

Contract type

Service contract

Procedure type

Open procedure (above threshold)

Any interested supplier may submit a tender in response to an opportunity notice.

This procedure can be used for procurements above the relevant contract value threshold.

Contract is suitable for SMEs?

No

Contract is suitable for VCSEs?

No

Description

Provision of external Quality Control testing services for the Cellular and Molecular Therapies (CMT) directorate within NHSBT, namely the Advanced Therapies Units (ATU) and Clinical Biotechnology Centre (CBC).
Testing Requirements

To include but not limited to with the right to add or remove tests:

In Process and Final Product testing using the following assays;

- Endotoxin (Ph. Eur. 2.6.14)

- Mycoplasma (Ph. Eur.2.6.7 or validated equivalent e.g PCR)

- Sterility (Ph. Eur. 2.6.1 or validated equivalent e.g. BacTALERT system).

- Karyotyping

- Bacterial Cell Bank Testing

- Mammalian Cell Bank Testing

- Specialised Viral Safety Testing

Regulatory Requirements

For a contractor to be considered the following specification has to be met:

- EU GMP licenced laboratory for QC testing of ATIMPs (cell based and molecular therapies), biotechnology and biological products

- FDA GMP licencing for QC testing of ATIMPs, biotechnology and biological products

- GLP

- Pharmacopoeia harmonised testing where possible

- Validation of all assays where required.

Other Requirements

- Service - quick and easy access to results and reports for validations and assays. Availability of a designated representative to discuss requirements.

- Quick turnaround times including report of findings and a Certificate of Results.

- Flexibility of service to allow changes that occur due to project based work.

- Bespoke testing for novel cellular and molecular therapies.

- Testing and reporting is performed to GMP

- Validation services - There may be the requirement to validate new/existing tests on a project by project basis

- Service Level Agreement between CMT and the contractor

- Quality Technical Agreement must be in place

- Supplier Evaluation must be performed

More information

Links

About the buyer

Contact name

Seun Ayandipo

Address

500 Northway, North Bristol Park
Bristol
BS34 7QH
England

Email

seun.ayandipo@nhsbt.nhs.uk