Can it explain the evidence behind a process parameter?

Katalyze can connect the relevant process documents, records, and scientific sources for experts to examine. The strength of the rationale depends on the evidence available. Missing information is surfaced rather than treated as an established justification.

How does Katalyze support process and control decisions?

Katalyze connects process knowledge, investigates questions, and helps draft supporting technical documents and action plans. Your CMC, process, and Quality experts assess the evidence and retain responsibility for the control strategy, process changes, and validation.

Can it help when process knowledge sits with a CDMO?

Relevant records from your organization and the CDMO can contribute where they are made available for the work. Your team can examine the supporting evidence, identify gaps in the process rationale, and prepare the questions or documentation needed for the next discussion.

How should we think about cell and gene therapy programs?

Start with the program-specific process and question. Cell and gene therapy materials, assays, and manufacturing steps need their own context. We scope the work around that evidence and your team's responsibilities.

Katalyze for CMC Teams

Keep the reasoning behind your process decisions.

Process decisions depend on understanding why a parameter, material requirement, or procedure was chosen. Katalyze connects that rationale to studies and manufacturing records, helping CMC experts assess a change or carry the knowledge into a transfer.

Book a Demo Explore Raw Material Characterization

Process understanding · material knowledge · transfer evidenceP-14 · master batch record, Rev 3 · March 2026

ParameterAs definedEvidenceSource
Feed strategyDefined in the master batch recordFeed addition later than planned on BR-0412 and BR-0421carried into the transfer as an open questionP-14 master batch record, Rev 3 · Feeding records
Feed materialLots 2231-A and 2231-B · certificates 0088 and 0091Composition data for 2231-B not in the review setMaterial record · certificates
Harvest titerThe analytical record's measureLower on BR-0412 and BR-0421 · comparable on BR-0415Harvest results · Snowflake
Analytical contextSampling stage and method as definedChecked before the comparison is readHarvest results · analytical record
The literatureCell-culture media variabilityInforms the hypotheses · establishes nothing about a batchPubMed · ScienceDirect

P-14 master batch record, Rev 3 · 12 batches · 2 lots · 1 question carried into the transfer

The working week

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

Mon 16

Tue 17

Wed 18

Thu 19

Fri 20

Recovering the process rationale: The reasoning behind a parameter or material requirement may sit across several records.
Connecting studies to manufacturing: Process characterization studies need to be interpreted alongside manufacturing history.
Preparing knowledge for transfer: The receiving team needs the evidence behind the procedure as well as the procedure itself.
Assessing the next process decision: CMC experts weigh the evidence, its limits, and the implications for the next stage.

Your systems

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
SnowflakeData platformsAvailable
SAPEnterprise systemsAvailable
Outlook / Microsoft GraphDocumentsAvailable
PubMedScientific sourcesAvailable
ScienceDirectScientific sourcesAvailable

Where to start

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
Raw Material Characterization
Examine material attributes and supplier information alongside the evidence relevant to process performance.
- lots 2231-A, 2231-B · certificates 0088, 0091
- composition data · not in the review set
- request the data · K. S.
→
02
Yield Optimization
Relate batch performance to process and material history when assessing what deserves further study.
- BR-0410 to BR-0421 · harvest titer
- feed timing · feed lot · compared
- next comparison · feed execution and material history
→
03
Tech Transfer
Prepare the process description and supporting evidence for the receiving team, with unresolved questions visible.
- P-14 · master batch record, Rev 3
- 4 items · Site A against Site B · 4 open
- Draft 1 · for review · J. M.
→

Who does what

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 CMC team
Your team defines the decision
Specify the process question, development stage, or transfer need the work should support.
master batch record, Rev 3 · P-14
Katalyze
Katalyze gathers relevant knowledge
Connect process documents, material information, system data, and applicable scientific sources.
12 batches · 2 lots · certificates 0088, 0091
Katalyze
Katalyze examines the evidence
Investigate the relationships relevant to the question and identify missing or uncertain information.
feed strategy · feed material · analytical context
Katalyze
Katalyze drafts supporting documents
Draft technical assessments or supporting transfer documentation, with source evidence and open questions for experts to review.
Material assessment · draft 1
Your CMC team
Your experts assess the implications
Judge what the evidence supports and what further work is needed for the process or program.
composition data requested · K. S.
Katalyze
Katalyze keeps the context available
Record the work so the established context can support later investigations and transfer questions.
run recorded · lineage kept

Customer experience

Katalyze in pharmaceutical operations.

See customer results

Questions

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.

See the platform

Katalyze for CMC Teams

Where your team's time goes.

Put the knowledge in your systems to work.

Where Katalyze can support your team.

Raw Material Characterization

Yield Optimization

Tech Transfer

Give your team time to work through the hard questions.

Your team defines the decision

Katalyze gathers relevant knowledge

Katalyze examines the evidence

Katalyze drafts supporting documents

Your experts assess the implications

Katalyze keeps the context available

Katalyze in pharmaceutical operations.

How Katalyze fits your team's work.

01Can it explain the evidence behind a process parameter?

02How does Katalyze support process and control decisions?

03Can it help when process knowledge sits with a CDMO?

04How should we think about cell and gene therapy programs?

More time for the work that moves medicine.