Batch 360

MES-26073In executionQA hold · Q-DEV-031

AB-mAb-014 (IgG1 Monoclonal Antibody) · BR-UP-01 2,000 L · Stage: Fed-Batch Stationary (Day 11/14)

ISA-88 procedure UP-01 · recipe RCP-AB014-V4Inoculated Oct 8 08:00 UTCManifest sha256:f3a91c07e5…7c3d25Demo · read-only

View events & genealogy Inspect investigation INV-104 Compare batches in Workbench

Recipe phases · RCP-AB014-V4

Oct 7
Media charge
T+0h
Inoculation
0–72h
Batch growth
72–120h
Fed-batch growth
05120–336h
Fed-batch stationary
Running · step 05.4 deviation
06Oct 22
Harvest
07Oct 22–23
Transfer & CIP

Yield position

Normalized yield index to date vs campaign target and prior batches

Yield index

Calculated

75.9−6.1 vs 82.0

vs MES-26071

Calculated

−5.3pts

81.2 → 78.4 → 75.9

Feed droop

Observation

−14.2%after T+264.4h

Feed delivered

Observation

254.2L

to date · Day 11 of 14

Normalized yield index (idx)

MES-26071MES-26072MES-26073Reference envelopeMissing telemetry (dashed = imputed, excluded from stats)

42-minute historian gap at T+182.0–182.7h Imputed

PI buffer overflow on Oct 15, 14:00–14:42 UTC. A Kalman-smoothed estimate is drawn dashed for visual continuity only; it is excluded from all yield and feed statistics on this page. The local HMI trend showed no alarms during the gap (operator note).

Step record

Chronological, from eBR, historian and LIMS · selected steps

Step	Description	Start	Duration	Status
01.2	Basal media BM-1184-03 charged, 1,620 L; equilibrated 36.8 °C	Oct 7 14:10	17.8 h	Complete
02.1	Inoculation from N-1 SUB-200-02 · VCD 0.47 ×10⁶/mL	T+0.0h	0.6 h	Complete
04.1	Feed start · PM-204 setpoint 16.90 mL/min (FM-2207)	T+72.0h	—	Complete
05.1	Temperature shift 36.8 → 34.0 °C	T+120.0h	1.4 h	Complete
—	Historian gap: no PI records for 42 min (PI buffer overflow)	T+182.0h	0.7 h	Data gap
05.3	Daily glucose bolus · day 9	T+216.0h	0.3 h	Complete
05.4	Bolus nutrient addition · feed PV 14.48 vs SP 16.90 mL/min (−14.3%)	T+264.0h	Running	Deviation
05.5	Day 11 in-process sample QC-948 pulled	T+262.0h	—	Result OOT

Linked sample `QC-948`

OOT

HPLC Protein A titer: 3.42 g/L
Specification: > 3.80 g/L
VCD: 14.8 x 10^6 cells/mL
Pulled: T+262.0h · Day 11
Analyst: M. Okafor · signed
Second review: Pending

In-process result. Release decisions use the harvest panel (QC-952), not yet pulled.

Open QC-948

Investigation

Hypotheses under review

INV-104 is evaluating three candidate explanations for the yield decline. One is supported by correlated evidence; two are contradicted. No root cause has been approved.

HypothesisA · Tubing fatigue / slip
ContradictedB · Media lot variation
ContradictedC · DO sensor drift

Inspect INV-104

Batch identity

Batch: MES-26073
Campaign: CMP-26-10
Unit: BR-UP-01
Feed pump: PM-204
Elapsed: T+272.7h
Planned end: T+336h · Oct 22
Release: Hold active
Process: UP-01

Recipe phases · RCP-AB014-V4

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