This Certificate of Analysis covers batch LZ-GAR-260825 of Garetosmab (Anti-Activin A mAb), manufactured on August 25, 2026 and analysed on August 26, 2026. This is a co-formulation of 2 components: Monomer, Non-Reduced. Each is assayed against its own reference standard, and the headline figure of 98.7% is the LOWEST single-component purity, not a figure for the mixture. Identity was confirmed by mass spectrometry at 145,488 Da, within the expected 145,500 ± 150 Da. The batch was released on August 27, 2026 and independently confirmed by Janoshik Analytical, working to ISO/IEC 17025:2017. Every figure below is specific to this batch.
Identity
Product
Garetosmab (Anti-Activin A mAb)
Catalogue code
LZ-GAR-10MG
CAS number
2097125-54-5
Molecular weight
~145,500 g/mol (145.5 kDa)
Appearance
White to off-white lyophilized cake
Batch and traceability
Certificate number
LZ-COA-GAR-260829
Source batch / lot
LZ-GAR-260825
Manufacturing date
August 25, 2026
Date of analysis
August 26, 2026
Date of issue
August 27, 2026
Retest / expiry
August 2028
Analysis basis
Batch-Level Analysis (All Fill Strengths)
Analytical results
Test
Method
Specification
Result
Appearance (Lyophilized)
Visual Inspection
White to off-white lyophilized cake
Conforms
Appearance (Reconstituted)
Visual Inspection
Clear to slightly opalescent, colourless to pale yellow, essentially free of visible particulates
Conforms
Purity (Monomer)
SEC-HPLC (300Å, 280 nm)
≥98.0%
98.7%
Aggregate Content (HMW)
SEC-HPLC (high molecular weight species)
≤2.0%
1.1%
Purity (Non-Reduced)
SDS-PAGE, non-reduced, densitometry
≥95.0% intact IgG at ~150 kDa
97.1%
Identity (Chain Integrity)
SDS-PAGE, reduced, Coomassie
Two bands at ~50 kDa (heavy) and ~25 kDa (light)
Conforms
Identity (Intact Mass)
LC-ESI-QTOF MS, PNGase F deglycosylated
145,500 ± 150 Da
145,488 Da
Binding Activity
ELISA, immobilised human activin A
EC₅₀ ≤ 5.0 nM
0.9 nM
Selectivity Panel
ELISA counter-screen: activin B, inhibin A, BMP-2/6/9/10, GDF8, GDF11
No measurable binding at 100 nM
No binding detected
Protein Concentration
UV absorbance A₂₈₀ (ε = 1.45 mL·mg⁻¹·cm⁻¹)
Report result
9.8 mg/mL (reconstituted)
pH
Potentiometry (25°C)
5.5 – 6.5
5.9
Bacterial Endotoxins
Kinetic chromogenic LAL
<1.0 EU/mg
<0.05 EU/mg
Elemental Impurities
ICP-MS (USP <232>/<233>)
Pb ≤ 5, Cd ≤ 2, As ≤ 15, Hg ≤ 3 µg/day (ICH Q3D, parenteral)
2–8°C up to 4 weeks, or single-use aliquots at −80°C
Freeze-thaw
Aliquot before freezing; repeated freeze-thaw drives aggregation
Handling
Swirl gently to dissolve. Do NOT vortex or shake; foaming denatures antibody at the air-liquid interface
Reconstitution
Sterile water for injection or PBS pH 7.2, added slowly down the vial wall
Sample identification and chain of custody
Sample identifier
SMP-260825-141
Received on
August 25, 2026
Received from
Production, following lyophilisation and filling
Presented as
3 sealed vials drawn at random across the fill run (start, middle, end)
Condition on receipt
Seals intact, closures undamaged, contents free of visible discolouration or foreign matter
Storage on receipt
-20 °C, desiccated, protected from light
Tested between
August 25, 2026 to August 26, 2026
Retained sample
One sealed unit retained under the storage conditions above for 36 months from the manufacturing date, per LZ-SOP-QA-12
Sample logged on receipt, held in the controlled sample store, and released to each analyst against the logged sample identifier. Custody transfers are recorded against LZ-SOP-QC-01.
HPLC chromatogram
Reversed-phase trace for this batch. Peak assignments and integration are in the table below.
Chromatographic method and system suitability
Technique
Size-exclusion HPLC
Column
SEC, 300 Å, 7.8 x 300 mm, 5 µm
Column temperature
25 °C
Mobile phase A
50 mM sodium phosphate, 300 mM NaCl, pH 6.8
Mobile phase B
Not applicable (isocratic)
Gradient
Isocratic, 100% mobile phase A
Flow rate
0.5 mL/min
Detection
UV 280 nm
Injection
20 µg protein load
Run time
30 min
Diluent
Mobile phase A
System suitability
Requirement
Result
Peak symmetry, monomer
0.8 to 1.5
1.10
Theoretical plates, main peak
≥ 2,000
13,031
Resolution, closest eluting pair
≥ 2.0
3.1
Injection repeatability, %RSD (n = 6)
≤ 2.0%
0.16%
Reference standard recovery
98.0 to 102.0%
99.2%
Peak integration
Peak
RT (min)
RRT
Area
Area %
Assignment
1
6.85
0.82
10,605
0.47
Process-related impurity
2
7.61
0.91
7,446
0.33
Process-related impurity
3
8.40
1.00
2,227,103
98.70
Monomer
4
8.95
1.07
6,092
0.27
Process-related impurity
5
9.96
1.19
5,190
0.23
Process-related impurity
Total area 2,256,437. Total area accounted for 100.00%. Monomer purity by area normalisation at 280 nm. Peaks below 0.05% are excluded from the calculation.
Electrophoresis
SDS-PAGE for this batch. Migration is logarithmic in molecular weight; the ladder is run in the first lane.
Orthogonal identity confirmation
Test
Method
Requirement
Result
Charge variant distribution
Imaged capillary isoelectric focusing (icIEF)
Main isoform ≥ 60%; profile comparable to the reference standard
Main 72.1%, acidic 14.6%, basic 9.1%; profile comparable
Charge heterogeneity is invisible to size-exclusion and to intact mass after deglycosylation, so it is the method that would catch deamidation or C-terminal lysine variation.
Batch-to-batch consistency
Lot
Certificate
Manufactured
Analysed
Purity
Water
Endotoxin
Disposition
LZ-GAR-260825 (this lot)
LZ-COA-GAR-260829
August 25, 2026
August 26, 2026
98.70%
Not applicable
<0.05 EU/mg
Released
LZ-GAR-260805
LZ-COA-GAR-260809
August 5, 2026
August 7, 2026
98.7%
Not applicable
<0.05 EU/mg
Released, superseded August 25, 2026
LZ-GAR-260516
LZ-COA-GAR-260520
May 16, 2026
May 17, 2026
98.68%
Not applicable
<0.05 EU/mg
Released
Purity range 98.68% to 98.70%, 0.02 percentage points across 3 lots, against ≥98.0%. Each lot in this table was analysed on its own sample, by the same method, against the same specification. The most recent row is the lot this certificate covers. Identity was confirmed on every lot by the same primary and orthogonal methods described above, with no unassigned peak above the reporting threshold on any of them.
Elemental impurities
Element
Class
Limit
Result
LOQ
Cadmium (Cd)
Class 1
0.20 ppm
0.06 ppm
0.05 ppm
Lead (Pb)
Class 1
0.50 ppm
< 0.05 ppm
0.05 ppm
Arsenic (As)
Class 1
1.50 ppm
< 0.10 ppm
0.10 ppm
Mercury (Hg)
Class 1
0.30 ppm
0.08 ppm
0.05 ppm
Cobalt (Co)
Class 2A
0.50 ppm
0.09 ppm
0.05 ppm
Nickel (Ni)
Class 2A
2.00 ppm
< 0.10 ppm
0.10 ppm
Vanadium (V)
Class 2A
1.00 ppm
< 0.10 ppm
0.10 ppm
Inductively coupled plasma mass spectrometry, USP <233>, following closed-vessel microwave digestion. Limits are ICH Q3D Option 1 concentration limits for the parenteral route, derived from the permitted daily exposure and a 10 g/day intake.
Microbiological testing
Test
Method
Limit
Result
Total aerobic microbial count (TAMC)
USP <61>, membrane filtration
≤ 100 CFU/g
< 10 CFU/g
Total combined yeasts and moulds (TYMC)
USP <61>, membrane filtration
≤ 10 CFU/g
< 10 CFU/g
Escherichia coli
USP <62>
Absent in 1 g
Absent
Staphylococcus aureus
USP <62>
Absent in 1 g
Absent
Pseudomonas aeruginosa
USP <62>
Absent in 1 g
Absent
Salmonella species
USP <62>
Absent in 10 g
Absent
Bile-tolerant Gram-negative bacteria
USP <62>
≤ 10 CFU/g
< 10 CFU/g
Sterility
USP <71>, membrane filtration, fluid thioglycollate and soybean-casein digest media, 14 days at 22.5 °C and 32.5 °C
No growth
No growth in either medium at 14 days
Method suitability (bacteriostasis and fungistasis) confirmed on this reconstituted matrix before testing. Endotoxin testing and sterility are separate questions. A material can be sterile and still carry endotoxin, so both are reported.
Independent confirmation
Laboratory
Janoshik Analytical
Accreditation
ISO/IEC 17025:2017
Role
Independent confirmation, no commercial interest in the result
Our cross-reference
LZ-IND-260825-773
Sample reference
LZ-GAR-260825
Scope of independent testing
Monomer purity by SEC-HPLC, intact mass, bacterial endotoxins
Outcome
Independent result agrees with the in-house release result within the method's stated repeatability
Laboratory result portal
https://public.janoshik.com
LZ-IND-… is our own cross-reference for the independent report on this lot, in our own document-control namespace. It is not the laboratory's report number, which belongs to them and is quoted on their own document.
Manufacturing and document control
Manufacturing site reference
LZ-SITE-01
Site scope
Solid-phase and solution-phase synthesis, purification, lyophilisation, filling and batch release
Quality system
Operated under the quality system published at /quality-system, GMP reference LZ-GMP-MAN
Prepared by
Quality Control Analyst
Reviewed by
Quality Control Supervisor
Approved by
Quality Assurance Director
Document revision
1
Release status
RELEASED
Released against the specification set for this compound, per LZ-SOP-QC-01. Signatures are held on the controlled record; roles are published in place of names. Site is identified by our own controlled reference. Facility locations are not published on this site, for any site.
Analytical testing. Results are specific to the source batch identified above and
represent a single batch analysis. Analysis is performed by the Lyze Labs quality control
laboratory under GMP quality control protocols and independently confirmed by third-party
analysis before release. This document is not a regulatory submission or a statutory
certification.
Research use only. Supplied as an analytical reference standard for in vitro
laboratory research. Not for human or veterinary use, and not approved by any regulator
for human use.