BioReliance (Merck)

Glasgow, UK · Rockville, MD
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-02
81.5
Signal Score
✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ✓ MHRA GMP (8)

Quick Facts: BioReliance (Merck)

Signal Score
81.5/100 (as of 2026-04-02)
Quality Compliance
99.8/100
Headquarters
Glasgow, UK · Rockville, MD
Modalities
AAV, Lentiviral, Biologics
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By
CDMO Signal — independent CDMO intelligence platform

Signal Score & Pillar Breakdown

Quality Compliance 99.8
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2024-11-22)
MHRA GMP Certificates8 on record
Operations
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs no verified data
Sponsorsno verified data
ModalitiesAAV, Lentiviral, Biologics
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability 68.0
Parent company: Merck KGaA
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: Merck KGaA
Financial assessment: 68.0/100
Capacity 63.0
2 manufacturing sites
Sites: Glasgow, UK, Rockville, MD
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
2 manufacturing sites

FDA Inspection History

2024-11
NAI VAI OAI
Date Site Type Observations Classification
2024-11-22 Rockville, Maryland Vaccines and Allergenic Products Yes Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Apr 05, 2026

MHRA GMP Compliance 8 certificates

2025-05
2025-05
2025-03
2025-03
2025-02
2025-02
2013-07
2012-07
Compliant Non-Compliant
Certificate Site City / Postcode Inspection Date Status
UK GMP 22774 Insp GMP/IMP 22774/31007-0023 [H] BIORELIANCE LIMITED STIRLING FK9 4NF 2025-05-02 COMPLIANT
UK GMP 22774 Insp GMP/IMP 22774/31007-0023 [V] BIORELIANCE LIMITED STIRLING FK9 4NF 2025-05-02 COMPLIANT
UK GMP 22774 Insp GMP/IMP 22774/2062763-0012 [H] BIORELIANCE LIMITED PENICUIK EH26 0PZ 2025-03-19 COMPLIANT
UK GMP 22774 Insp GMP/IMP 22774/2062763-0012 [V] BIORELIANCE LIMITED PENICUIK EH26 0PZ 2025-03-19 COMPLIANT
UK MIA 22774 Insp GMP 13987/4473-0031[H] BIORELIANCE LIMITED GLASGOW G20 0XA 2025-02-13 COMPLIANT
UK API 22774 Insp GMP 13987/4473-0031 BIORELIANCE LIMITED GLASGOW G20 0XA 2025-02-13 COMPLIANT
UK GMP 18729 Insp GMP 18729/376405-0002[H] BIORELIANCE CORPORATION 20850-3349 2013-07-15 COMPLIANT
UK MIA 22774 Insp GMP/IMP 22774/31007-0012[H] BIORELIANCE LIMITED STIRLING FK9 4NF 2012-07-25 COMPLIANT
Source: MHRA GMDP Database · Retrieved Apr 05, 2026
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