Minaris Advanced Therapies

Philadelphia, PA · Allendale, NJ · Munich, DE · Yokohama, JP

Profile last updated: 2026-08-18

CAR-T Cell Therapy

No confirmed program data — ClinicalTrials.gov verification pending · Last scored 2026-09-07

83.3

Signal Score

✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ✓ Press (2) ✓ EMA GMP (2) ✓ MHRA GMP (4)

Quick Facts: Minaris Advanced Therapies

Signal Score: 83.3/100 (as of 2026-09-07)
Quality Compliance: 99.6/100
Headquarters: Philadelphia, PA · Allendale, NJ · Munich, DE · Yokohama, JP
Modalities: CAR-T, Cell Therapy
Active Programs: Data pending
Data Sources: FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By: CDMO Signal — independent CDMO intelligence platform

About Minaris Advanced Therapies

Merged WuXi AT + PCT/Hitachi. Acquired by Altaris from WuXi AppTec (2024).

Signal Score & Pillar Breakdown

Scores are being republished. Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.

Quality Compliance

FDA Inspections1 on record

Warning Letters0

Last InspectionVoluntary Action Indicated (VAI) (2025-09-29)

EMA GMP Certificates2 on record

MHRA GMP Certificates4 on record

Operations —

No ClinicalTrials.gov facility matches confirmed for this manufacturer.

Programs — no verified data

Sponsors— no verified data

ModalitiesCAR-T, Cell Therapy

Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.

Financial Stability

Profile-based financial assessment

SEC FilingsPrivate company

Capacity

Capacity status: Limited

Status

Recent Press2 articles

Minaris Advanced Therapies FDA Inspection History

2025-09

NAI VAI OAI

Date	Site	Type	Observations	Classification
2025-09-29	Minaris Regenerative Medicine, LLC Allendale, New Jersey Facility-linked	Human Cellular, Tissue, and Gene Therapies	Yes	Voluntary Action Indicated (VAI)

Source: FDA Data Dashboard · Retrieved Oct 06, 2026

Minaris Advanced Therapies EMA GMP Compliance 2 certificates

2025-07

2024-02

Compliant Non-Compliant

Certificate	Site	Country	Inspection Date	Status
DE_BY_04_GMP_2026_0001	MINARIS Regenerative Medicine GmbH	Germany	2025-07-30	COMPLIANT
DE_BY_04_GMP_2026_0002	MINARIS Regenerative Medicine GmbH	Germany	2024-02-08	COMPLIANT

Source: EMA EudraGMDP · Retrieved Oct 06, 2026

Minaris Advanced Therapies MHRA GMP Compliance 4 certificates

2017-03

2009-04

Compliant Non-Compliant

Certificate	Site	City / Postcode	Inspection Date	Status
UK GMP 35210 Insp GMP 35210/978451-0004[H]	WUXI APPTEC INCORPORATED	30066	2017-03-02	COMPLIANT
UK GMP 35210 Insp GMP 35210/935445-0001 [H]	WUXI APPTEC INCORPORATED	19112	2009-04-30	COMPLIANT
UK GMP 35210 Insp GMP 35210/935445-0001 [V]	WUXI APPTEC INCORPORATED	19112	2009-04-30	COMPLIANT
UK GMP 35210 Insp GMP 35210/940604-0001[H]	WUXI APPTEC INCORPORATED	55120	2009-04-27	COMPLIANT