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Advanced Testing

Independent characterization of LuvionBio test articles that goes beyond a purity number. Our current work: cell-based functional-potency studies performed by Reaction Biology Europe GmbH against commercial reference standards, using cAMP-based receptor activation in engineered HEK293 cell lines.

Purity tells you what is in the bottle. A cell-based potency comparison tells you whether what is in the bottle activates the intended receptor the same way a recognized commercial reference standard does — at the same concentration range, in the same direction, with the same shape of dose response. Our stability studies then track how that material holds up in solution over time. Together they are an early step toward functional benchmarking in the research-use-only market.

Cell-Based Potency Studies

Project PQ25445 · 31 March 2026

GLP-1 — Cell-Based Assay Performance

cAMP-based GLP-1R activation in engineered HEK293 cells, 10-point dose range, 4-parameter logistic fit.

9.5%
EC₅₀ difference from reference
Excellent alignment (≤10%)
1.05×10⁻¹⁰
LuvionBio EC₅₀ (g/mL), GLP-1R
1.16×10⁻¹⁰
Reference EC₅₀ (g/mL)

The LuvionBio test article and the commercial reference standard produced nearly superimposable dose-response curves on GLP-1R, with EC₅₀ values within roughly one part in ten of one another.

Project PQ25445 · 31 March 2026

GLP-2 — Cell-Based Assay Performance

cAMP-based activation measured at GLP-1R and GIP-R in engineered HEK293 cells. “GLP-2” is the LuvionBio internal product designation; the assay measures activity at the GLP-1R and GIP-R receptors against a commercial reference standard.

8.0%
GLP-1R EC₅₀ difference
Excellent alignment (≤10%)
6.2%
GIP-R EC₅₀ difference
Excellent alignment (≤10%)
2 receptors
GLP-1R & GIP-R, closely overlapping curves

Across both receptors, the LuvionBio test article and the commercial reference standard produced closely overlapping dose-response curves, with EC₅₀ values within approximately 6–8% of one another — both inside the top tier of LuvionBio’s internal comparative review framework.

Each potency report includes full methodology, the interpretation framework, a claims-substantiation review, and an RUO compliance statement. These are single-batch comparative potency assays — not regulatory potency assays or release specifications.

Stability Studies

A purity number tells you what is in the vial on day one. A time-course stability study tells you whether what is in the vial stays what it was — measured repeatedly across reconstitution and storage, on the same instrument, against a defined grading framework. Each lot below was independently tested by Freedom Diagnostics (USA) over a 28-day reconstituted-solution window.

Lot LBL-0625-10NJ5-1031 · 28-Day Study

NAD+ 500 MG — 28-Day Stability

Reconstituted-solution purity (HPLC-UV / LC-MS) and pH measured across five timepoints over 28 days.

0.10%
Total purity drift (Day 1 → 28)
High-Grade
0.07
Total pH variation (5.59–5.66)
High-Grade
99.8%+
Purity held across all 5 timepoints

Purity stayed above 99.8% and moved no more than 0.13% peak-to-trough; solution pH held within 0.07 units across the full 28 days — both inside the High-Grade tier of LuvionBio’s internal stability framework.

Lot LBL-0625-RT10-1027 · 28-Day Study

GLP-3 — 28-Day Stability

Reconstituted-solution purity (HPLC-UV / LC-MS) and pH measured across five timepoints over 28 days. MS identity GLP-3 (CAS 2381089-83-2).

0.04%
Total purity drift (Day 1 → 28)
High-Grade
0.51
Total pH excursion (7.12–7.63)
Acceptable
99.70%+
Purity held across all 5 timepoints

Purity was the standout — just 0.04% drift over 28 days, deep inside the High-Grade tier. Solution pH was more variable (0.51-unit total excursion, Acceptable tier); because purity stayed essentially flat over the same window, that pH movement most likely reflects measurement and handling variability, and is reported transparently as found.

Each stability report is interpreted against LuvionBio’s internal grading framework (disclosed in full) and includes the original signed certificate of analysis, independently verifiable by accession number. These are single-lot studies — not regulatory stability programs or release specifications.