Deep in advanced therapy and pharma operations.
Three domains that overlap far more than most consultancies admit. The hard problems live in the overlap, where a manufacturing constraint turns into a data problem and then into an inspection finding. DigiSci Consulting works at that junction rather than on either side of it.
Cell & Gene Therapy
Advanced therapies break the assumptions conventional manufacturing is built on. Batch sizes of one, living materials and a chain of identity that cannot fail, all under GMP, with EU ATMP Regulation 1394/2007 Article 15 requiring traceability held for thirty years. Manufacturing capability rather than molecule is the durable advantage in this sector, which is why the digital design has to start at the process.
- Tech transfer from development to GMP, with comparability and process characterisation
- Chain-of-identity and chain-of-custody design against the thirty-year traceability obligation
- CDMO selection, oversight and readiness review
- Deviation reduction at root-cause level across recurring classes
Pharmaceutical Manufacturing
DigiSci Consulting treats data, process and compliance as one system rather than three departments. Throughput and inspection risk usually sit in the seams between them. Value has moved to the data layer, so adoption and data quality come before any predictive layer is worth building.
- PQS design and build against a locked specification with an automated compliance gate
- Data integrity and audit trail design to ALCOA+
- Process Analytical Technology and process monitoring
- CDMO oversight and inspection readiness
AI in Regulated Environments
The constraint on AI in pharma is permissibility rather than capability. A model that performs well still has to demonstrate intended use, reproduce a decision for an inspector and survive change control, and the business case has to carry the cost of all three. Human oversight here means oversight that changes outcomes, not oversight that signs off.
- Intended-use definition and validation strategy, with GAMP 5 categorisation applied per configured module
- Data integrity and audit trail design, with a six-link traceability chain from requirement to evidence
- CSA and CSV change-control paths, with vendor pre-executed qualification treated as vendor evidence
- ISO/IEC 42001 gap analysis crosswalked against draft EU GMP Annex 22