Services

The CTP offers our partners a one-stop solution to advance projects from preclinical development to all phases of clinical trials. Our capabilities include product manufacturing, quality control and regulatory services, together with guidance for investigational new drug (IND) application preparation and submission.

USC CHLA Services Infographic

CTP Offerings

Project consultation/support

  • Provide early advice on best translational and clinical development pathways
  • Develop effective and tailored regulatory strategies
  • Support grant applications for onboarded projects
  • Support clinical study design and choice of endpoints
  • Assist in writing of Chemistry, Manufacturing, and Controls section (CMC) for investigational new drug (IND) submissions
  • Offer training programs for workforce development 

Process development

  • Establish a comprehensive technology-transfer strategy
  • Optimize manufacturing workflow, including upstream and downstream processes
  • Develop Standard Operating Procedures (SOPs) and Target Product Profile (TPP)
  • Develop validated quality control assays/protocols
  • Shift from open to closed manufacturing systems
  • Scale up/out production processes

cGMP manufacturing for clinical trials

  • Manufacture of biologics and cell therapy products
  • cGMP viral vector production
  • Starting material, in-process and drug product testing e.g., identity, purity, potency, stability, viability, and safety
  • Final product formulation and cryopreservation (if applicable)
  • Integrated quality assurance system