Thermo Fisher Scientific
Plainville, MA · Alachua, FL · Cambridge, MA
2 confirmed programs
· 2 sponsors
· Last scored 2026-04-29
81.5
Signal Score
✓ FDA Inspections (5)
✓ Clinical Trials (2)
✓ SEC Filings (16)
✓ Press (20)
✓ EMA GMP (1)
✓ MHRA GMP (9)
Quick Facts: Thermo Fisher Scientific
- Signal Score
- 81.5/100 (as of 2026-04-29)
- Quality Compliance
- 94.1/100
- Headquarters
- Plainville, MA · Alachua, FL · Cambridge, MA
- Modalities
- AAV, Lentiviral, Plasmid DNA, Adenoviral
- Active Programs
- 2 confirmed from ClinicalTrials.gov across 2 sponsors
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Thermo Fisher Scientific
Acquired Brammer Bio ($1.7B, 2019).
Signal Score & Pillar Breakdown
Quality Compliance
94.1
FDA Inspections5 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2026-05-07)
EMA GMP Certificates1 on record
MHRA GMP Certificates9 on record
Operations
60.0
2 active programs across 2 sponsors
Modalities: Adenoviral, AAV, Plasmid DNA, Lentiviral
2 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
2 active programs across 2 sponsors · Modalities: Adenoviral, AAV, Plasmid DNA, Lentiviral · 2 programs in advanced phases (Phase 2/3)
Programs
2
Sponsors2
ModalitiesAAV, Lentiviral, Plasmid DNA, Adenoviral
2 active programs across 2 sponsors
Modalities: Adenoviral, AAV, Plasmid DNA, Lentiviral
2 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
Partnership Announcements (from press monitoring)
Source: ClinicalTrials.gov · Retrieved Jul 04, 2026
Financial Stability
78.0
Publicly traded — financial transparency
Moderate industry presence in SEC filings (12 mentions)
Source: SEC EDGAR, press monitoring
16 SEC filings with industry mentions on record
SEC Filings16 with industry mentions
Publicly traded — financial transparency
Moderate industry presence in SEC filings (12 mentions)
Capacity
90.0
3 manufacturing sites
Broad modality coverage (4 modalities)
3 facility investment mentions in SEC filings
Active facility expansion (2 articles)
Regulatory milestones (2 articles)
Sites: Plainville, MA, Lexington, MA, Alachua, FL
Source: SEC EDGAR, press monitoring, company profiles
3 manufacturing sites
StatusAvailable
3 manufacturing sites
Broad modality coverage (4 modalities)
3 facility investment mentions in SEC filings
Active facility expansion (2 articles)
Regulatory milestones (2 articles)
Sites: Plainville, MA, Lexington, MA, Alachua, FL
Recent Press20 articles
3 manufacturing sites
Broad modality coverage (4 modalities)
3 facility investment mentions in SEC filings
Active facility expansion (2 articles)
Regulatory milestones (2 articles)
Thermo Fisher Scientific FDA Inspection History
2026-05
2025-09
2025-09
2025-07
2024-11
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-05-07 | Allentown, Pennsylvania | Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-09-26 | Greenville, North Carolina | Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-09-26 | Cincinnati, Ohio | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-07-17 | High Point, North Carolina | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2024-11-20 | Saint Louis, Missouri | Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Jul 04, 2026
Thermo Fisher Scientific FDA 483 Findings 47 observations · 2025-07-17 → 2026-02-05 ?
By subsystem
By severity
- 3 — Moderate: 6
- 2 — Minor: 41
- Repeat observations: 0
Most severe findings
-
Lack of or inadequate procedures
"Procedures for corrective and preventive action have not been adequately established."
-
Written procedures - establish; returned dietary supplements
"You did not establish written procedures for when a returned dietary supplement is received, when a returned dietary supplement must be destroyed, or otherwise suitably disposed, when a returned dietary supplement may be salvaged, for conducting an investigation of your manufacturing processes and other batches for a returned dietary supplement and quality control personnel to approve a returned dietary supplement for reprocessing."
-
Lack of or inadequate procedures
"Procedures for corrective and preventive action have not been adequately established."
Thermo Fisher Scientific EMA GMP Compliance 1 certificates
2025-11
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| CRN00GTCX/ASR12633 | Thermo Fisher Scientific Cork Limited | Ireland | 2025-11-07 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Jul 04, 2026
Thermo Fisher Scientific MHRA GMP Compliance 9 certificates
2024-10
2024-10
2024-07
2024-07
2024-07
2021-03
2019-08
2019-01
2017-01
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK MIA 18693 Insp GMP/GDP/IMP 18693/11204-0018[H] | FISHER CLINICAL SERVICES UK LIMITED | HORSHAM RH12 4QD | 2024-10-08 | COMPLIANT |
| UK MIA(IMP) 18693 Insp GMP/GDP/IMP 18693/11204-0019[I] | FISHER CLINICAL SERVICES UK LIMITED | HORSHAM RH12 4QD | 2024-10-08 | COMPLIANT |
| UK MIA 17857 Insp GMP/IMP 17857/10036-0034[H] | PATHEON UK LIMITED | SWINDON SN3 5BZ | 2024-07-29 | COMPLIANT |
| UK MIA(IMP) 17857 Insp GMP/IMP 17857/10036-0034[I] | PATHEON UK LIMITED | SWINDON SN3 5BZ | 2024-07-29 | COMPLIANT |
| UK MIA(IMP) 32390 Insp GMP/IMP 32390/411870-0007[I] | THERMO ELECTRON LIMITED | BISHOP'S STORTFORD CM23 5RG | 2024-07-16 | COMPLIANT |
| UK MIA(IMP) 17857 Insp GMP/IMP 17857/14285-0011[I] | PATHEON UK LIMITED | ABINGDON OX14 4SD | 2021-03-24 | COMPLIANT |
| UK MIA(IMP) 32390 Insp IMP 32390/18853104-0001[I] | THERMO ELECTRON LIMITED | STEVENAGE SG1 2FX | 2019-08-29 | COMPLIANT |
| UK MIA(IMP) 18693 Insp GMP/GDP/IMP 18693/11485563-0003[I] | FISHER CLINICAL SERVICES LIMITED | CRAWLEY RH10 9NL | 2019-01-21 | COMPLIANT |
| UK GMP 20788 Insp GMP 20788/13917-0005[H] | PATHEON PHARMACEUTICALS INCORPORATED | 45237 | 2017-01-17 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved Jul 04, 2026
Clinical Activity 2 studies
NCT02340936
Clinical Trial to Determinate Dose, Security and Efficacy or Lenalidomide...
PHASE1/PHASE2
Completed
NCT00982111
First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell...
PHASE3
Completed
Source: ClinicalTrials.gov · Retrieved Jul 04, 2026
Financial Intelligence
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
Source: SEC EDGAR · Retrieved Jul 04, 2026
Recent News 20 articles
Thermo Fisher Unveils Integrated Platform to Advance Scalable Cell Therapy Manufacturing - Digital Health News
Thermo Fisher Unveils Integrated Platform to Advance Scalable Cell Therapy Manufacturing Digital Health News
Thermo Fisher Scientific Unveils an Integrated Platform to Advance Scalable Cell Therapy Manufacturing - FinancialContent
Thermo Fisher Scientific Unveils an Integrated Platform to Advance Scalable Cell Therapy Manufacturing FinancialContent
Thermo Fisher Scientific Introduces Gibco CTS DynaXS Single Use Bioreactor - Contract Pharma
Thermo Fisher Scientific Introduces Gibco CTS DynaXS Single Use Bioreactor Contract Pharma
Thermo Fisher Scientific Unveils an Integrated Platform to Advance Scalable Cell Therapy Manufacturing - New Castle News
Thermo Fisher Scientific Unveils an Integrated Platform to Advance Scalable Cell Therapy Manufacturing New Castle News
Thermo Fisher Scientific Unveils an Integrated Platform to Advance Scalable Cell Therapy Manufacturing - The Joplin Globe
Thermo Fisher Scientific Unveils an Integrated Platform to Advance Scalable Cell Therapy Manufacturing The Joplin Globe
Thermo Fisher introduces integrated platform to advance scalable cell therapy manufacturing - BioSpectrum India
Thermo Fisher introduces integrated platform to advance scalable cell therapy manufacturing BioSpectrum India
Thermo Fisher Scientific launches applied Biosystems PowerFlex Thermal Cycler - Med-Tech Insights
Thermo Fisher Scientific launches applied Biosystems PowerFlex Thermal Cycler Med-Tech Insights
Thermo Fisher Scientific, SHL Medical Collaborate on Integrated Drug-Device Solutions - Medical Product Outsourcing
Thermo Fisher Scientific, SHL Medical Collaborate on Integrated Drug-Device Solutions Medical Product Outsourcing
Thermo Fisher Scientific Opens U.S. Flagship Bioprocess Design Center to Accelerate the Delivery of - PharmiWeb.com
Thermo Fisher Scientific Opens U.S. Flagship Bioprocess Design Center to Accelerate the Delivery of PharmiWeb.com
Thermo Fisher Scientific opens bioprocess design center with 4,000 sq. ft. of lab and training space - R&D World
Thermo Fisher Scientific opens bioprocess design center with 4,000 sq. ft. of lab and training space R&D World
Thermo Fisher opens Plainville design center amid $2B push for U.S. manufacturing - The Business Journals
Thermo Fisher opens Plainville design center amid $2B push for U.S. manufacturing The Business Journals
Thermo Fisher opens new facility for vaccine, gene therapy development - The Boston Globe
Thermo Fisher opens new facility for vaccine, gene therapy development The Boston Globe
Thermo Fisher Scientific Expands Plainville Facility With Flagship Bioprocess Design Center To Advance Biologics Development - BioPharma APAC
Thermo Fisher Scientific Expands Plainville Facility With Flagship Bioprocess Design Center To Advance Biologics Development BioPharma APAC
Thermo Fisher Scientific sells microbiology business for $1B to European private equity firm - Fierce Biotech
Thermo Fisher Scientific sells microbiology business for $1B to European private equity firm Fierce Biotech
Thermo Fisher CEO says onshoring push will bring a ‘tailwind’ for the Waltham company - The Business Journals
Thermo Fisher CEO says onshoring push will bring a ‘tailwind’ for the Waltham company The Business Journals
Healthcare Filtration Markets 2025-2035 with Focus on Biologics Manufacturing Featuring Alfa Laval, Asahi Kasei, Cobetter, Corning, Merck, Pall, Parker Hannifin, Sartorius, Thermo Fisher Scientific - Yahoo Finance
Healthcare Filtration Markets 2025-2035 with Focus on Biologics Manufacturing Featuring Alfa Laval, Asahi Kasei, Cobetter, Corning, Merck, Pall, Parker Hannifin, Sartorius, Thermo Fisher Scientific Yahoo Finance
Thermo Fisher Launches Automated Cell Therapy System - Technology Networks
Thermo Fisher Launches Automated Cell Therapy System Technology Networks
Thermo Fisher Launches Automated Cell Therapy System - Technology Networks
Thermo Fisher Launches Automated Cell Therapy System Technology Networks
How Investors May Respond To Thermo Fisher Scientific (TMO) Expanding Its Cell Therapy And Biologics Platforms - Sahm
How Investors May Respond To Thermo Fisher Scientific (TMO) Expanding Its Cell Therapy And Biologics Platforms Sahm
Thermo Fisher Scientific introduces the Gibco CTS Compleo Fill and Finish System - SelectScience
Thermo Fisher Scientific introduces the Gibco CTS Compleo Fill and Finish System Select Science
Frequently Asked Questions About Thermo Fisher Scientific
How many FDA inspections does Thermo Fisher Scientific have on record?
CDMO Signal tracks 5 FDA inspections for Thermo Fisher Scientific, sourced from the FDA inspection database. See the full inspection history above.
Has Thermo Fisher Scientific received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Thermo Fisher Scientific.
Does Thermo Fisher Scientific hold EMA or MHRA GMP certificates?
CDMO Signal tracks 1 EMA and 9 MHRA GMP certificates for Thermo Fisher Scientific.
How many clinical programs is Thermo Fisher Scientific linked to?
Thermo Fisher Scientific is associated with 2 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.
What is Thermo Fisher Scientific's CDMO Signal Score?
Thermo Fisher Scientific has a Signal Score of 82/100, based on quality, operations, financial stability, and capacity data.
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