PrymaLab

PrymaLab Analytical · In-house laboratory

3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net

Certificate no.

PL-26-00003

Verification key

DWUV94CU

Scan or enter both at
prymalab.net/testing/verify

Certificate of Analysis · Lot release

ACE-031 1 mg

Lot PL-2609-003 · Lyophilized powder · Label claim 1 mg/vial

Tested in-house by PrymaLab

In-house analytical result,
not an independent third-party test

Lot / batch number

PL-2609-003

Date made

2026-09-18

Date of analysis

2026-09-19

Date issued

2026-10-03

Retest / expiry

2028-09-18

Units in lot / sampled

250 / 2

Storage

−20 °C, desiccated, dark; avoid freeze–thaw after reconstitution

Certificate type

Lot COA, 2 pages

Compound

ACE-031

ActRIIB-Fc decoy receptor: soluble activin receptor type IIB extracellular domain fused to human IgG1 Fc

CAS number

Not assigned

Molecular formula

Not applicable (recombinant glycoprotein)

Theoretical mass (avg.)

Glycoform-dependent; unreduced Fc-fusion homodimer about 72–75 kDa

Structure

Recombinant human ActRIIB extracellular domain fused to human IgG1 Fc (hinge–CH2–CH3), CHO-expressed; covalent homodimer through the Fc hinge disulfides; N-glycosylated. Binds GDF-8/GDF-11, activin A and BMP-9/10.

Purity · RP-HPLC, area %

98.1%

Specification ≥ 95.0% (SDS-PAGE corroboration) • main peak at 7.38 min

Identity · Observed Mass

72,529 Da

Deconvoluted glycoform centroid • spec ≤ 75,000 Da (unreduced dimer)

Overall conclusion

PASS

Meets every specification for the tests performed

Test	Method	Specification	Result	Conclusion
Appearance	Visual inspection	White to off-white lyophilized powder or cake	White lyophilized powder	PASS
Identity	LC-MS, ESI positive	Deconvoluted mass within glycoform envelope	72,529 Da (dimer); 36,268 Da on reduction	PASS
Purity	RP-HPLC, UV 214 nm, area%	≥ 95.0%	98.1%	PASS
Largest impurity	RP-HPLC, area%	≤ 5.0%	1.4% at 6.86 min	PASS
Water content	Karl Fischer	5.0%	2.1%	PASS
Bacterial endotoxin	LAL, kinetic	≤ 5.0 EU/mg	0.31 EU/mg	PASS
Sterility / bioburden	USP <71>, membrane filtration	No growth after 14 days	No growth; conforms	PASS

1HPLC chromatogram

Data file: ACE_PL-2609-003_20260919_01 · Column C18, 150 × 4.6 mm · UV 214 nm

Baseline uncropped; main peak and impurities labeled with retention times. Peak table on page 2.

PrymaLab

Certificate of Analysis · continued

ACE-031 1 mg · Lot PL-2609-003 · Certificate PL-26-00003

Lot PL-2609-003

Method, peak table and approval

2HPLC method · ACE_PL-2609-003_20260919_01

Instrument

Waters Alliance e2695, SN E2695B742

Data System

Empower 3, Build 3471

Detector

Waters 2998 PDA

Detection Wavelength

214 nm

Column

C18, 150 × 4.6 mm, 3.5 µm

Column Part / Serial

186003326 / USHX18211

Mobile Phase B

0.1% TFA in MeCN

Flow Rate

1.0 mL/min

Column Temperature

30 °C

Injection Volume

20 µL

Run Time

10 min

Sample Diluent

Water, 0.1% TFA

Sample Concentration

0.5 mg/mL

Blank Injected

Yes

Reference Standard

In-house ACE-031 reference, lot PL-RS-ACE-01, RT 7.36 min (SDS-PAGE ref: NSA1, lot APP2012MA6)

3Gradient program

Time (min)	% A	% B
0.0	95	5
3.0	95	7.0
7.0	55	45
8.0	20	80
9.0	20	80
10.0	95	5

4Peak table

Peak	RT (min)	Area	Area %
1	6.20	21,500	0.5
2	7.38	4,217,300	98.1
3	7.98	61,200	1.4
Total		4,300,000	100.0

Threshold 0.05% area · Blank subtracted: Y · Purity = main peak area ÷ total integrated area × 100, to two decimals; main peak shaded.

5Identity by mass spectrometry

Instrument

SQD, ESI positive

Ionization / Mode

ESI, positive

Observed m/z (charge)

2401.9 (30+ [M+30H]) · 2183.5 (33+ [M+33H])

Deconvoluted Mass

72,529 Da (centroid glycoform)

Theoretical Mass

~72,000 Da (glycoform envelope)

Difference

2.6 kDa CHO glycoform spread

Data File

ACE_PL-2609-003_MS_20260919_01

Acceptance

Within glycoform envelope

6Additional tests

Test	Performed by	Date	Report / file
Water content	PrymaLab	2026-09-20	RPT-KF-PL-2609-003
Endotoxin	PrymaLab	2026-09-21	RPT-ET-PL-2609-003

A test with no row here was not performed on this lot. Outside-laboratory reports, when used, are attached and named below.

7Review and approval

D. Reynolds
Analyst · performed the testing
Date: 2026-09-19

S. Calloway
Reviewer · checked against raw data
Date: 2026-10-02

M. Phelps
Lab Director · approved for release
Date: 2026-10-03