- Cell Line Development
- Master Cell Banking (MCB)
- Working Cell Banking (WCB)
- Clarified Harvest/Purification Product
- Stability Studies for Preclinical (GLP Tox Batch) and clinical (GMP Batch)
- Stability Protocols
- Stability Reports
- DS/DP storage
- BDS Production & Release for Preclinical and Clinical batches
- Harvest Sampling Plan and QC Test Data
- Product Release Forms
- Executed Batch Records
- Drug Substance and Drug Product Specifications
- Sampling Plans
- DP: Finished, Packaged and Labelled clinical batches
- Product Disposition
- Shipment of Investigational Drug Product and Receipt at Investigator Sites
- Management of Temperature Excursions
- Regulatory Inspections
- Stability study design, initiation and management for investigational products
- Setting and revising use periods for investigational products
