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Highlighting requirements of the "Process Development & Manufacturing for GLP Pre-Clinical Studies" stage for successful biologics translation.
Some important definitions for Process Development & Manufacturing for GLP Pre-Clinical Studies:
Contract Manufacturing Organisation (CMO)
- Appointed by UCL for the design, manufacture, packaging and labelling of a non-GMP or GMP compliant biologic for pre-clinical studies and clinical trials
- Operates under a ‘Master Services Agreement (MSA) and Schedule of Work (SoW)’ which defines terms, scope, objectives, timelines and deliverables of the work package
- Operates under a ‘Quality Agreement (QA)’ which define quality assurance & regulatory requirements
- May themselves sub-contract tasks or testing
Contract Research Organisation (CRO)
- Appointed by UCL for the design and performance of pre-clinical study
- Operates under a MSA, SoW, QA
Raw Materials Supplier
- Certified provider of pharmacopeia-grade materials for GMP compliant manufacture
- Supplies to contract manufacturer under the terms of their Contract Manufacturing Agreement
Outsourced Work Considerations
- Outsourced work is budgeted as exceptional costs on funding application
- UCL procurement rules (Tender required for £50K+ contracts/animal work exempt)
- VAT considerations
PROCESS DEVELOPMENT:
Factors to consider:
- Upstream and downstream processes require development
- Scalable processes/GMP considerations for clinical manufacture?
- Formulation studies
NON-GMP MANUFACTURING:
Considerations - Batch manufacture to ‘GMP-like’ compliance; Generation of a suitable product for GLP toxicology studies; Fill finish requirements.
NON-GMP BIOLOGIC:
Questions to answer - Is the biologic fit-for-purpose and does it meet release criteria? Can it be used to obtain preliminary stability data?
GLP TOXICOLOGY STUDY:
Study must mimic intentions of the clinical trial, dosing regimen, route of administration dose.
Lack of toxicity with relevant animal model(s) must be demonstrated.
UCL Support:
The UCL Translational Research Group (TRG)'s expertise and knowledge of the biologics field means that they know which non-GMP manufacturers are in the best position to help and allow you to start the conversation with them.
If employing a contract manufacturing organisation (CMO), UCL Research Services and the Joint Research Office (JRO) shall co-develop the Contract Manufacturing Agreement. The JRO shall lead on the development of the Quality Agreement to ensure Good Manufacturing Practice (GMP) regulatory compliance (e.g. audit of the CMO).
All CMOs will be required to provide technical documentation to the legal manufacturer or its appointed delegate. All documentation relating to manufacturer and suppliers shall be included the Investigational Medicinal Product Dossier (IMPD) and Investigator Brochure (IB) for the Clinical Trial Application (CTA).