Asklepios BioPharmaceutical (AskBio)

Research Triangle, NC · San Sebastian, ES

Hybrid — also manufactures internal programs

AAV

10 confirmed programs · 4 sponsors · Last scored 2026-04-29

61.8

Signal Score

○ FDA Inspections ✓ Clinical Trials (10) ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: Asklepios BioPharmaceutical (AskBio)

Signal Score: 61.8/100 (as of 2026-04-29)
Quality Compliance: Assessment pending
Headquarters: Research Triangle, NC · San Sebastian, ES
Modalities: AAV
Active Programs: 10 confirmed from ClinicalTrials.gov across 4 sponsors
Data Sources: FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By: CDMO Signal — independent CDMO intelligence platform

About Asklepios BioPharmaceutical (AskBio)

Hybrid developer + CDMO.

Signal Score & Pillar Breakdown

Quality Compliance —

No FDA inspection records found. This CDMO may operate under a different legal name or may not have US FDA-inspected facilities.

FDA InspectionsNo US records on file

No FDA inspection records found for this manufacturer

Quality score requires FDA inspection data

Operations

10 active programs across 4 sponsors · Modalities: AAV · 5 programs in advanced phases (Phase 2/3)

Programs 10

Sponsors4

ModalitiesAAV

10 active programs across 4 sponsors

Modalities: AAV

5 programs in advanced phases (Phase 2/3)

Source: ClinicalTrials.gov facility matching

NCT07566429 A Study of AB-1005 Gene Therapy in Japanese Adults With... PHASE2 Not Yet Recruiting

NCT07282847 A Study to Evaluate Safety, Tolerability, and Efficacy of... PHASE1/PHASE2 Recruiting

NCT07081841 AB-1005 Long-Term Follow-up Study NA Enrolling By Invitation

NCT06285643 A Study of AAV2-GDNF in Adults With Moderate Parkinson's... PHASE2 Recruiting

NCT05598333 Phosphatase Inhibition by Intracoronary Gene Therapy in... PHASE2 Active Not Recruiting

NCT05230459 A Study to Evaluate the Safety of AB-1003 (Previously... PHASE1/PHASE2 Recruiting

NCT05699460 Pre-Gene Therapy Study in Parkinson's Disease and Multiple... NA Active Not Recruiting

NCT04167540 GDNF Gene Therapy for Parkinson's Disease PHASE1 Active Not Recruiting

NCT03533673 AAV2/8-LSPhGAA (ACTUS-101) in Late-Onset Pompe Disease PHASE1 Completed

NCT00428935 Safety Study of Mini-dystrophin Gene to Treat Duchenne... PHASE1 Completed

Source: ClinicalTrials.gov · Retrieved May 20, 2026

Financial Stability

Profile-based financial assessment

SEC FilingsPrivate company

Parent company: Bayer

Financial assessment: 68.0/100

Capacity

2 manufacturing sites

FDA 483 Findings 5 observations · 2025-11-18 → 2025-11-18 ?

By subsystem

Documentation & Records 4 (80.0%)
Other 1 (20.0%)

By severity

2 — Minor: 5
Repeat observations: 0

Most severe findings

Minor (2) Documentation & Records 2025-11-18 21 CFR 111.260

Batch record - required information

"Your batch production record did not include all required information."
Minor (2) Other 2025-11-18 21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

"You did not qualify a supplier of a component by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations."
Minor (2) Documentation & Records 2025-11-18 21 CFR 111.70(e)

Specifications - finished dietary supplement

"You did not establish product specifications for identity, purity, strength and composition."