NHSBT1245/S/SP - External Testing Services

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