Katalyze for Companies Preparing for Commercial Manufacturing
Carry your process knowledge into commercial manufacturing.
As commercial manufacturing approaches, the evidence behind the process needs to travel across internal teams and manufacturing partners. Katalyze connects that knowledge so experts can investigate questions, prepare transfer documentation, and decide what needs attention.
- Process definitionP-14 master batch record, Rev 3Linked · with the rationale behind itVeeva Vault
- Supporting recordsFeeding records · harvest resultsLinked · BR-0410 to BR-0421Document Intelligence · Snowflake
- Material historyLots 2231-A and 2231-BLinked · certificates 0088 and 0091SAP
- Receiving-site questionsSite B4 open · for the receiving teamfeed strategy · feed material · bioreactor operation · harvest samplingTransfer comparison
- Transfer documentationDraft 1For review · with the receiving teamTech Transfer · run recorded
5 items · 4 open questions · every value with its source
Where your team's time goes.
Finding records, reconciling details, and writing up findings leave less time for the next technical question.
Explore Document Intelligence- Knowledge across partners
- Bring together the relevant information made available by internal teams, CDMOs, suppliers, and testing partners, so experts can trace a question across the records that support it.
- Questions that cross functions
- A material or performance question may involve CMC, MSAT, and Quality. Give the experts a source-linked basis for examining the issue and deciding what work follows.
- Evidence for the receiving team
- Help draft supporting transfer documentation from the process records and rationale, with open questions visible for your experts and the receiving team.
- Deciding what needs attention
- Your experts refine the reasoning and decide what further analysis, transfer work, or process change is needed.
Put the knowledge in your systems to work.
Connect the information the job needs. Your existing systems remain the source of truth.
Explore connectors- Veeva VaultDocumentsAvailable
- SharePointDocumentsAvailable
- SAPEnterprise systemsAvailable
- SnowflakeData platformsAvailable
- Outlook / Microsoft GraphDocumentsAvailable
- SFTPFile storesAvailable
Where Katalyze can support your team.
Connect the knowledge each solution needs, then use it to investigate questions and prepare work for review.
Explore all solutions- 01
Tech Transfer
Assemble process knowledge into documentation and plans that help the receiving team examine its open questions.
- P-14 · master batch record, Rev 3 · to Site B
- 4 items · 4 open
- Draft 1 · for review
- 02
Raw Material Characterization
Investigate material and supplier differences in the context of the process your team is preparing to manufacture.
- lots 2231-A, 2231-B · certificates on file
- composition data · not in the review set
- request the data
- 03
Yield Optimization
Connect process records and material history to examine a change in performance and decide what deserves further study.
- 12 batches · harvest titer
- feed timing · feed lot · compared
- BR-0415 · same lot · comparable
Give your team time to work through the hard questions.
Katalyze investigates evidence and drafts documents. Your experts refine the work and decide what follows.
How Agentic Solutions work- Your commercial-stage developers team
Your team defines the transfer question
Specify the process, the partners involved, and the decision the work should support.
P-14 · Site A to Site B - Katalyze
Katalyze connects the process knowledge
Bring the development and manufacturing records, the material history, and the partners' information into the Context Layer.
12 batches · 2 lots · 3 systems · lineage kept - Katalyze
Katalyze examines the open questions
Compare the process definition with the receiving site's context and surface what is missing or uncertain.
4 items · 4 open - Katalyze
Katalyze drafts the transfer documentation
Draft supporting transfer documentation and plans, with the evidence and the open questions visible for review.
Transfer documentation · draft 1 - Your commercial-stage developers team
Your experts decide what needs attention
Refine the reasoning and decide what further analysis, transfer work, or process change follows.
Revised · J. M. · equivalence not established - Katalyze
Katalyze keeps the context for the program
Record the run and keep the established context available as the program takes on its next question.
run recorded · lineage kept
Katalyze in pharmaceutical operations.
What really separated Katalyze was that it was built for an enterprise like Sanofi from day one. The ontology layer was already in place. Data ingestion into the intelligence layer was solved. They had the security, the governance, the deployment story, everything we needed to scale this across R&D, not just run a pilot in one corner of the organization.
Sabya DGlobal Head (VP) R&D Data Platforms & Products- Plant throughput
- Up 25%
- Increased productivity
- 30%
- Faster batch release
- 40%
How Katalyze fits your team's work.
Explore the records, responsibilities, and review process behind the work.
More time for the work that moves medicine.
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.