宅男视频

XClose

UCL Therapeutic Innovation Networks

Menu

Process Development & Manufacturing for GLP Pre-Clinical Studies (Biologics)

Highlighting requirements of the "Process Development & Manufacturing for GLP Pre-Clinical Studies" stage for successful biologics translation.

Biologics roadmap

Some important definitions for听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 鈥楳aster Services Agreement (MSA) and Schedule of Work (SoW)鈥� which defines terms, scope, objectives, timelines and deliverables of the work package
  • Operates under a 鈥楺uality Agreement (QA)鈥� 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 拢50K+ contracts/animal work exempt)
  • VAT considerations

lab equipment
PROCESS DEVELOPMENT:

Factors to consider:

  • Upstream and downstream processes require development
  • Scalable processes/GMP considerations for clinical manufacture?
  • Formulation studies

GMP manufacturing
听NON-GMP MANUFACTURING:听

Considerations听 - Batch manufacture to 鈥楪MP-like鈥� compliance; Generation of a suitable product for GLP toxicology studies; Fill finish requirements.

antibody icon
听NON-GMP BIOLOGIC:

Questions to answer - Is the biologic听fit-for-purpose and听does it meet听release criteria?听Can it be used to obtain preliminary stability data?

rat icon
GLP TOXICOLOGY STUDY:

听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.听

UCL Support:

罢丑别听UCL Translational Research Group (TRG)'s听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.听

If employing a contract manufacturing organisation (CMO), UCL Research Services and the Joint Research Office听(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).听

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).听

听