Within cell and gene therapy projects, it is a common need to contract out some of the work to CRO's externally, outside of Ïã¸ÛÁùºÏ²Ê.
GMP MANUFACTURING:
Outsourced work – exceptional costs?
Ïã¸ÛÁùºÏ²Ê procurement rules for work over £50k.
CRO manufacturer will usually operate under a Master Services Agreement (MSA) and Schedule of Work (SoW) which defines terms, scope, objectives, timelines and deliverables of the work package.ÌýIf a collaborator rather than a fee for service supplier, there will also be a collaboration agreement.Ìý
- Engage early to reduce risk– ensure due diligence with all CROs completed. Slots for CRO: check details – delays etc
- Contract agreements for preclinical GLP Toxicology & GMP CROs, CTUs – secure SoWs - all agreements in conjunction with Ïã¸ÛÁùºÏ²Ê Research Services, TRO and Ïã¸ÛÁùºÏ²ÊB
- GMP batches ready – supply chain secured – stability and potency ongoing for duration of studies
Ïã¸ÛÁùºÏ²Ê Support:Ìý
The Ïã¸ÛÁùºÏ²Ê Translational Research Office (TRG)'sÌýexpertise and knowledge of the cell and gene therapy field means that they know which GMP manufacturers are in the best position to help and allow you to start the conversation with them.Ìý
CLINICAL TRIALS APPLICATIONÌý(CTA) SUBMISSION:
All documentation relating to manufacturer, suppliers needs to be included for a CTA - ie, IMPD/IB, HRA – MHRA class gene therapies as ATMPs (Directive 2001/83/EC, ATMP regulation 1394/2007 applies)
Committee for Advanced Therapies (CAT) oversee all marketing authorisations
Ïã¸ÛÁùºÏ²Ê Support:Ìý
There are several clinical trial units that the Ïã¸ÛÁùºÏ²Ê Translational Research Group can liase with, including:Ìý
- Cancer Research UK & Ïã¸ÛÁùºÏ²Ê Cancer Trials Centre
- Comprehensive Clinical Trials Unit at Ïã¸ÛÁùºÏ²Ê
- Medical Research Council Clinical Trials Unit at Ïã¸ÛÁùºÏ²Ê
- PRIMENT Clinical Trials Unit
The TRG work with theÌýJoint Research OfficeÌýtoÌýhandle clinical trial related work.Ìý
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