Process context

UP-011 CPP outside range

The upstream-to-capture lifecycle for AB-mAb-014. Select a stage to see its critical process parameters, quality attributes and how recent batches compare.

Recipe RCP-AB014-V4Active batch MES-26073 · T+264.4hCPP snapshot 08:26 UTCDemo · read-only

View SOP-UP-014 revisions Historical batches Open selected unit in Workbench

Lifecycle map

Seed train through capture · select a stage

Critical process parameters · BR-UP-01

Live snapshot at T+264.4h · green band = recipe range

Observation

Dissolved O₂

39.4%

Range 35–45

7.04

Range 6.90–7.20

Agitation

85.0rpm

Range 80–90

Feed flow

14.48mL/min

Range 15.8–17.6 · SP 16.90

Feed flow 14.48 mL/min is below the 15.8 mL/min lower limit

−14.3% against setpoint since T+264.4h, coincident with PM-204 head pressure at 1.48 bar. DO, pH and agitation remain in range. Open PM-204

Stage summary

Fed-batch production with temperature shift at T+120h and continuous feed from PM-204.

Unit: BR-UP-01
Phase: 05 · Stationary
Elapsed: T+272.7h / 336h
Feed pump: PM-204
Temp SP: 34.0 °C
Governing SOP: SOP-UP-014 Rev 7

Critical quality attributes

Latest in-process results for MES-26073

Titer
Out of trend
3.42 g/LSpec > 3.80 g/L (Day 11 in-process)HPLC Protein AQC-948Observation
Aggregates (HMW)
Within spec
1.8 %Spec ≤ 3.0 %SEC-HPLCQC-944Observation
Charge variants (acidic)
Within spec
24.1 %Spec 18–30 %CEX-HPLCQC-944Observation
Glycan (G0F)
Not tested until harvest
—Spec 35–55 %HILIC-FLDQC-952 (planned)Unknown

Unit-run variance audit · BR-UP-01

Same unit, same recipe, three campaign batches

Calculated

Parameter	MES-26071	MES-26072	MES-26073	Range
Mean DO, Phase 05 (%)	40.1	39.8	39.4	35–45
Mean pH, Phase 05	7.05	7.04	7.04	6.90–7.20
Agitation (rpm)	85.0	85.1	85.0	80–90
Mean feed flow T+240–280h (mL/min)	16.88	16.41	14.48	15.8–17.6
Peak PM-204 head pressure (bar)	0.98	1.06	1.48	≤ 1.20
Feed delivered (to T+264h) (L)	291.4	284.9	254.2	Trend only
Day 11 titer (g/L)	3.98	3.81	3.42	> 3.80
Final normalized yield index (idx)	81.2	78.4	75.9	Target 82.0

Environmental CPPs (DO, pH, agitation) are near-identical across batches; differences concentrate in feed delivery and pump pressure. This narrows where to look but does not establish cause.

Sources: Plot in Workbench

Note

Earlier-batch feed delivered is computed to the same elapsed hour (T+264h) for a like-for-like comparison.

Note

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