Lower temperature
PD-024
- Titre
- 2.6 g/L
- Viability
- 94%
- Working volume
- 2 L
- Feed
- 6 g/L/h
- Temperature
- 35 °C
Find the process worth taking forward.
For Process Development teams working across upstream, downstream and analytical development. Ask neil to compare runs, prepare the next study and carry the science into scale-up and transfer.
Bring your development study
Which process should we take forward?
You: PD-024 has the highest titre. Should we take that process forward?
neil
It is a candidate, not yet a winner. PD-024 produced 2.6 g/L, but both feed and temperature changed from the reference run. Let’s look at what each result actually represents.
Viability (%)
Titre (g/L)
View all values
| Record | Titre (g/L) | Viability (%) |
|---|---|---|
| PD-021 | 1.8 | 95 |
| PD-022 | 2.4 | 91 |
| PD-023 | 2.3 | 88 |
| PD-024 | 2.6 | 94 |
You: Which comparison tells us the most about feed?
neil
PD-021 against PD-022: both use 2 L and 37 °C, while feed changes from 4 to 6 g/L/h. Titre rises from 1.8 to 2.4 g/L; viability falls from 95% to 91%. That is the closest comparison in this set. With one run per condition and incomplete lot and method context, I would not call it a demonstrated feed effect.
You: Prepare the next study and the decision we need it to support.
neil
I’ve separated the two changed factors into a four-condition study. The proposal keeps the run records, measurements and open design decisions together, ready for the scientist to review.
PD-025 / next-study proposal
DraftSeparate the feed and temperature effects before selecting the process.
35 °C37 °C4 g/L/h2 L2 L6 g/L/h2 L2 L
“We have been delighted with the rigour and agility shown by Seal in providing Ingenza with a robust GxP system that fully supports our process development and biomanufacturing operations.”
One process. Several disciplines.
Keep specialist work connected through the runs, materials and measurements it shares.
Upstream development
Run comparison and proposed follow-up experiments.
Upstream development
Run comparison and proposed follow-up experiments.
Compare feed, culture conditions and actual run profiles without losing vessel, material or sample context.
Explore upstream developmentDownstream development
Step-recovery assessment with sample and pool lineage.
Downstream development
Step-recovery assessment with sample and pool lineage.
Follow recovery and quality across unit operations, pools and fractions. Locate the loss before choosing what to change.
Explore downstream developmentAnalytical development
A comparison that exposes method changes and missing context.
Analytical development
A comparison that exposes method changes and missing context.
Keep method versions, standards and sample preparation attached to the result used in a process decision.
Explore analytical developmentProcess characterisation
A study package with evidence and assumptions for review.
Process characterisation
A study package with evidence and assumptions for review.
Connect the study question, parameter ranges, responses and analysis to the proposed process understanding.
Explore process characterisationWork across the systems you already use.
Connect permitted records from your ELN, LIMS, historian, ERP and documents—or start with supplied data. neil brings the relevant evidence into the work in Seal.
Procedures & quality records
Samples & analytical results
Materials & production context
Development & transfer documentsHow access and connections work
Connections and available actions depend on the source system, API and configured permissions. Agree the records and access for the job; retain source references and versions in the output. Connecting a system does not grant neil unrestricted access or permission to change it.
Explore the connectionsTransfer the understanding, not just the recipe.
Carry the evidence and the unresolved question together. In this study, the strongest result and the larger-scale run used different conditions.
PD-024
- Working volume
- 2 L
- Feed
- 6 g/L/h
- Temperature
- 35 °C
PD-023
- Working volume
- 20 L
- Feed
- 6 g/L/h
- Temperature
- 37 °C
Does the 35 °C condition hold up at 20 L?
These runs do not answer that yet. Keep the scale question with the candidate, so MSAT can assess the evidence and plan the next work.
See how MSAT carries the process forwardSee how the comparison is prepared.
3 minQuestions from Process Development teams.
This blueprint connects the process definition to structured runs, actual conditions, samples, results and assessed claims. The transfer package retains that context. It supplies the receiving team with evidence and a starting definition, not an automatically approved manufacturing recipe.
Yes. Enforcement is configurable. During early development, scientists capture data in a structured framework but aren't constrained by it. As the process matures, controls tighten. The system adapts to the process lifecycle, not the other way around.
Transfer the selected definition with its run evidence, parameter rationale, equipment requirements and unresolved gaps. The receiving site maps its equipment and instructions, verifies the controls and approves the intended recipe. Preserve links to the development versions.
Legacy development data can be imported and linked to process definitions. The value compounds going forward. New development work is structured from the start, and legacy data provides historical context.
Development and manufacturing can share linked definitions and evidence in Seal. Manufacturing configures and verifies the site-specific recipe, execution fields, exception paths and approvals before use. Development results do not by themselves authorise manufacturing execution.
Define the intended use, record controls, permissions, review and verification required for your development work. Your organisation assesses the applicable requirements and qualifies the configured workflow. Exploratory and controlled studies can use different permissions and review paths; software alone is not a compliance determination.
Promotion supplies a governed starting definition and its evidence. Manufacturing still configures and approves the site-specific recipe, equipment mapping, instructions, controls, exceptions, and validation state. Seal removes re-entry and lost context without bypassing manufacturing or quality approval.
Typical criteria include a selected candidate, defined unit operations and parameters, representative materials and analytics, repeatability, scale-model rationale, sampling strategy, preliminary risk and control understanding, source-data completeness, and owned knowledge gaps.
They remain part of the process evidence. Factors, actual execution, results, exceptions, conclusions, and failure modes are searchable and can support risk assessments, operating boundaries, investigations, and avoidance of repeated dead ends.
Process development explores and selects the process candidate. Characterization systematically quantifies parameter and material effects on process performance and quality attributes to support a control strategy. Seal connects them through the same candidate, runs, parameters, samples, and claims.