P-14
What the operation makes.
Material in SAPProduct on the batch record
The Context Layer
Your Manufacturing Operation as Code.
A connected, source-grounded view of the operational information needed for the work: your documents, your system data and the scientific sources your teams rely on, organized by a customer-specific Ontology and a Knowledge Graph that keeps every result linked to its original source, without requiring data migration.
- operationSite A · fed-batch culture · product P-14SAP · plant
- recipeP-14 master batch record · Rev 3Veeva Vault · controlled document
- specificationP-14 · Rev 2Veeva Vault · controlled document
- procedurescell culture and harvest SOPs · in forceSharePoint · Document Intelligence
- equipmentproduction bioreactor · 2000 L · Site ASAP · equipment master
- materialcell-culture feed · lots 2231-A, 2231-B this quarterSAP · material master
- certificates2231-A · 0088 · 2231-B · 0091 · on fileOutlook · the supplier's email
- compositiondata for lot 2231-B · not in the review setcertificate 0091 · flagged
- batchesBR-0410 to BR-0421 · the comparison setbatch records · Document Intelligence
- feedsfeed 3 recorded late · BR-0412 · BR-0421batch records · feeding record
- deviationsDV-0088 · feed 3 later than planned · openVeeva Vault · deviation record
- samplesharvest · lower titer on BR-0412, BR-0421Snowflake · harvest results
- literaturefeed timing and harvest titer · 3 studiesPubMed · ScienceDirect
Where the knowledge lives
Knowledge exists across the organization and its partners.
Putting it to use demands work of its own: finding the right information, reconciling what different records say and assembling the evidence needed to begin. Recipes, procedures, batch records and lab reports on paper and in PDFs; materials, suppliers and equipment in SAP; process and sample data in Snowflake; deviations and controlled documents in Veeva Vault; the literature in PubMed. Each names the operation's things its own way, so every question starts by assembling them by hand.
Why was harvest titer lower on BR-0412 and BR-0421?
Documents
- Batch recordsfeeding records · section 6
- Master batch recordP-14 · Rev 3 · feeding schedule
- SOPscell culture and harvest
- Harvest resultstiter by HPLC · p. 2
- Certificates of analysis0088 · 0091 · the feed lots
Systems
- SAPprocess orders · feed lot by batch
- Snowflakeharvest titer · BR-0410 to BR-0421
- Veeva VaultDV-0088 · the master batch record
- SharePointthe P-14 tracker · batches by lot
- Outlookthe supplier's email · certificates
Scientific sources
- PubMedfeed timing · harvest titer
- ScienceDirectcell-culture media variability
Turn time spent finding information into time spent moving forward.
Explore Document IntelligenceThe Ontology
A model of how your operation defines and relates its concepts.
Entities, relationships, schemas and vocabulary specific to your operation and the first job, created and tuned by Katalyze around your terminology, processes and use case. Katalyze brings the domain expertise and reusable patterns; the concepts, the names and the relationships are your operation's own.
Book a DemoP-14 · Rev 3
How a product is meant to be made.
master batch record in Veeva Vaultplanned feed times on the feeding record
P-14 · Rev 2
What a product has to meet to be released.
specification in Veeva Vaultspecification on a certificate of analysis
cell-culture feed
What goes into a product.
material in SAPFeed lot on the feeding record
2231-A · 2231-B
A quantity of a material received at once.
Lot No. on a certificate of analysisbatch in SAP, its word for a lot
BR-0412
One run of a product, through harvest.
Batch No. on the batch recordprocess order in SAP
DV-0088
A departure from the recipe, and what was done.
Deviation in Veeva Vaultsee DV-0088 in a margin note
harvest · BR-0412
What was taken from a batch to test.
Harvest sample on the feeding recordharvest results in Snowflake
3 studies
Published work the operation relies on.
studies in PubMedarticles in ScienceDirect
The Knowledge Graph
A connected map of your operation's entities and their relationships.
Built on the Ontology from the linked data and the source records, with pointers back to the original documents and systems of record. Agents establish ground truth by querying it and validating findings against source evidence; your experts question it in plain language. Katalyze surfaces missing or uncertain information instead of allowing unsupported conclusions to pass silently.
How compliance worksThe questionWhy was harvest titer lower on BR-0412 and BR-0421?
P-14monoclonal antibody · Site A
Known asMaterial in SAP · P-14 mAb on the batch record · P-14 in the master batch record · P-14 in the tracker
recipemaster batch record · Rev 3Veeva Vault · controlled document
specificationRev 2Veeva Vault · controlled document
batches12 · BR-0410 to BR-0421batch records · Document Intelligence
harvest titerlower on BR-0412 and BR-0421Snowflake · harvest results
deviations1 open · DV-0088Veeva Vault · deviation record
feed lots this quarter2231-A, 2231-BSAP · material master
literature3 studiesPubMed · ScienceDirect
How it is built
Connects without data migration.
Document Intelligence extracts and contextualizes information from operational documents, while Connectors bring in relevant system data, scientific datasets, research publications and other academic sources. Together, these inputs feed the Context Layer. Customer systems remain the source of truth.
Explore ConnectorsWhat runs on it
Each new solution builds on the same platform and Context Layer.
Agents establish ground truth by querying the Context Layer and validating findings against source evidence, then investigate and execute governed work. App Studio lets teams build dashboards and applications from reusable components backed by the same connected information, and search and question it in plain language. Start with one job, Document Intelligence or an Agentic Solution; the context it builds gives the next a head start.
All Agentic SolutionsAgents act on it
Experts ask questions of it
Results
Put more of your expertise into progress.
What teams put the connected context toward: faster batch release, shorter deviation investigations and more of their experts' time on the science.
See customer resultsThe ontology layer was already in place. Data ingestion into the intelligence layer was solved.
Sabya DGlobal Head (VP) R&D Data Platforms & Products- Live on your existing stack, not months
- 2 weeks
- Of the pharma top 20 run Katalyze
- 5
- Doses delivered with Katalyze
- 10M
FAQ
Questions about the Context Layer.
What it connects, how it is built around your operation, and what it changes for the next question. The full set of answers is in the FAQ.
Book a demo
Give the next question a head start.
Bring the job you want to move forward and the records you'd like connected. Thirty minutes on how Katalyze would do the work, and where your experts come in.
Or, just a quick chat to run through the product, your call.