Biopharmaceutical manufacturing: connect every lot to its data, from formulation to release
A clinical lot fails its SEC high molecular weight species limit. The next questions are which drug substance lot went into it, what its acceptance results were, and whether other lots used the same material. In many biopharma programs the formulation sits in a spreadsheet, the lot genealogy in batch records and the release and stability results in separate lab systems, so someone rebuilds the history by hand.
Uncountable’s software for pharmaceutical and biotech teams puts formulations, process steps, material lots, release results, stability data and specifications on one data model. Each line records the exact lot it used, each result sits beside the limit it was checked against, and every field change is kept in an audit log. When a result fails, your team follows the chain from the drug product lot to its drug substance lot and its acceptance results on the same record.
This solution brief is for manufacturing, quality, validation and data leaders at biopharmaceutical companies who want faster, better-documented investigations from development to clinical supply.
Inside this solution brief:
- Drug substance, excipients, process parameters and test results recorded as typed fields with units
- Lot genealogy from each drug product lot to its drug substance lot
- Release results checked against the specification on every lot
- Stability curves compared across candidates, next to the formulation
- Instrument files parsed into structured results, and connections to your other systems
- Audit logs, PIN signatures and phase reviews
- A worked example: from a failed release result to its lots
Start every investigation from the lot record, not from a search. For more depth, read the guide Biopharma CMC without the data gaps.
FAQs
How Uncountable connects formulations, process steps, material lots, release results, stability data and specifications on one data model for biopharmaceutical manufacturing, from lot genealogy and spec checks to stability, instrument data, integrations and audit trails.
Each line of a record carries the exact lot it used, so each drug product lot can be traced to its drug substance lot and that lot's acceptance results. When a release result fails, the team follows the chain from the lot through its related experiments.
Each lot carries its release specification, with the limit next to each value. Values that meet the specification show green and values that fail show red, so a failed limit is visible on the same record as the lots behind it.
Yes. Excel, CSV, XML and instrument exports are parsed into structured results, and other systems connect through the Python SDK, the API, scheduled jobs and webhooks.
Every field change is kept in an audit log, records can be locked with a PIN signature, and phase reviews can be required before a record moves on. Access is granted by project or experiment, on a platform with SOC 2 Type II and ISO 27001.
