Harvest sample · MES-26073 day 11

QC-948OOT alertSign-off 1 of 2

Sample-centric view of the LabWare LIMS result set RS-77120 and its Waters Arc HPLC raw data. Results and signatures remain in LIMS; nothing here changes them.

Result set RS-77120Method HPLC-PROA-01 v4Demo · read-only

Inspect linked batch record Flag for OOT investigation Review assay record in approvals

Harvest titer

Observation

3.42g/Lspec > 3.80

Viable cell density

Observation

14.8×10⁶ cells/mL

Within campaign trend

Dual sign-off

1 of 2

QA reviewer pending

Titer gap to alert limit

Calculated

−0.38g/L−10.0%

(3.42 − 3.80) / 3.80

Waters Arc HPLC · chromatogram

Run ARC-2-26-1019-04 · injection 3 of 3 · 280 nm · no baseline correction

Hover trace for readout

Peak	RT (min)	Area (mAU·min)	% area
Flow-through	1.10	2.57	4.6
Pre-peak	3.62	1.12	2.0
IgG1 monomer	4.25	49.80	88.9
Post-peak	5.05	2.52	4.5

Calculated Areas re-integrated here (trapezoid, flat baseline 2 mAU) for orientation only; the reportable value is the LIMS result.

Test battery

All tests on QC-948 from LIMS result set RS-77120

Observation

Test	Method	Result	Unit	Specification	Status
Harvest titer (Protein A HPLC)	HPLC-PROA-01	3.42	g/L	> 3.80 (alert)	OOT
Viable cell density	VICELL-VCD-02	14.8	×10⁶ cells/mL	Report (trend 12–20)	Within trend
Viability	VICELL-VIAB-02	86.1	%	≥ 80.0	Pass
GlucoseLower third of range	CEDEX-GLU-04	1.9	g/L	1.0 – 6.0	Pass
Lactate	CEDEX-LAC-04	2.6	g/L	≤ 3.0	Pass
Ammonium	CEDEX-NH4-04	6.9	mmol/L	≤ 8.0	Pass
OsmolalityWithin spec, near upper limit	OSMO-03	371	mOsm/kg	280 – 380	Alert
SEC monomerAggregation impact unknown	SEC-UPLC-05	—	%	≥ 95.0	Not started

SEC monomer has not been run, so aggregate formation cannot be ruled in or out. Titer OOT is an alert-limit excursion pending review, not a confirmed failure.

Dual-analyst sign-off

1 of 2 complete · signatures held in LabWare LIMS

Primary analyst · M. Okafor
Signed 2026-10-19 11:40 UTC · meaning: “Performed”
Signed
QA reviewer · Priya Natarajan
Second-person review · waiting 5 d
Pending

Review assay record in approvals

The second signature is applied in LIMS. The review center prepares the evidence package only.

Sample

Batch: MES-26073
Skid: BR-UP-01
Sample point: SP-2 · day 11
Molecule: AB-mAb-014
Instrument: ARC-HPLC-02
Column lot: CA-2231

LIMS record hash

sha256:8f2c39d91f…2de901

System suitability

Observation

RT RSD0.21%≤ 1.0%Pass

Area RSD0.64%≤ 2.0%Pass

Ref std RS-IGG1-09 recovery99.1%95–105%Pass

Suitability passed, so an assay error is less likely, but it is not excluded until QA review.

Chain of custody

Drawn at BR-UP-01 sample port SP-2
2026-10-19 06:12 UTC · T. Reed · Suite 3B
Received at QC Lab 2 · 4.1 °C
2026-10-19 06:31 UTC · J. Alvarez · QC Lab 2
Aliquoted ×4 (QC-948-A…D)
2026-10-19 07:05 UTC · J. Alvarez · QC Lab 2
Injected on ARC-HPLC-02
2026-10-19 10:20 UTC · M. Okafor · QC Lab 2
Result entered · primary signature
2026-10-19 11:40 UTC · M. Okafor · LabWare LIMS

Context

Observation Linked deviation Q-DEV-031 covers the PM-204 feed droop on the same batch.

Campaign: CMP-26-10 · AB-mAb-014 (IgG1 Monoclonal Antibody)

Next steps

Flag for OOT investigation Inspect linked batch record

Next steps

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