BIOSECURE HDBO — GMP manufacturing

In conventional pharmaceutical manufacturing a batch serves thousands of patients. In autologous cell therapy every batch is one patient, and giving a product to the wrong person is not recoverable. The record system is therefore not a by-product of manufacturing; it is part of it.

Chain of identity and chain of custody

Chain of identity is the evidence that a product remains linked to the correct patient or donor from source to administration. Chain of custody is the record of who is accountable for it at any moment. Between the apheresis clinic, the manufacturing facility, quality control, storage, transport and clinical use there are many handovers; each is captured as a scan, a responsible party and a temperature record.

Processes are defined, not hard-coded

CAR-T, mesenchymal stromal cells from Wharton's jelly, adipose or bone marrow, SVF, CD34 selection, dendritic cell products, chondrocytes and plasmid or lentiviral production all run in the same facility with different step counts, sequences and data patterns. Processes are defined with a drag-and-drop designer and versioned; a quality control box can be attached to any step.

What an electronic batch record must solve

1. Blocking progression until in-process quality results are entered
2. Recording the lot and expiry of every consumable and the calibration status of every instrument against the batch
3. Placing environmental data — differential pressure, temperature, humidity, particulates, oxygen and carbon dioxide — on the same timeline as the manufacturing step
4. Flagging exceptions automatically and linking them to deviation and CAPA records
5. Producing forms automatically and releasing product under electronic signature

Quality control panel

Sterility, mycoplasma, replication competent virus, endotoxin, immunophenotyping by flow cytometry, viability and PCR or ddPCR results are held as related records and bound to the batch, together with consumable and environmental quality data.

Regulatory frame

The design follows cGMP and EU GMP Annex 1 for the manufacturing environment, 21 CFR Part 11 and EU Annex 11 for electronic records and signatures, and GAMP 5 for a risk-based validation lifecycle.