bluebird bio Manufacturing
Durham, NC
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
78.5
Signal Score
○ FDA Inspections
○ Clinical Trials
✓ SEC Filings (11)
○ Press
○ EMA GMP
○ MHRA GMP
Quick Facts: bluebird bio Manufacturing
- Signal Score
- 78.5/100 (as of 2026-09-07)
- Quality Compliance
- Assessment pending
- Headquarters
- Durham, NC
- Modalities
- Lentiviral, 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 bluebird bio Manufacturing
Manufactures Zynteglo and Lyfgenia gene therapies.
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
—
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
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesLentiviral, Cell Therapy
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
86.0
11 SEC filings with industry mentions on record
SEC Filings11 with industry mentions
Capacity
71.0
Profile-based capacity assessment
Financial Intelligence
"These forward-looking statements include, but are not limited to, statements about:
•
our entrance into an Agreement and Plan of Merger (the "Merger Agreement") with Beacon Parent Holdings, L.P., a Delaware limited partnership ("Parent"), and Beacon Merger Sub, Inc., a Delaware corporation ("Merger Sub"), including our beliefs about the potential benefits of the transaction contemplated by the Merger Agreement; and the planned completion and timing of the transaction contemplated by the Merger A"
"•
Among other potential adverse events, insertional oncogenesis is a significant risk of gene therapies using viral vectors that can integrate into the genome."
"The Company is a biotechnology company committed to commercializing potentially curative gene therapies for severe genetic diseases based on its proprietary lentiviral vector ("LVV") gene addition platform."
"These forward-looking statements include, but are not limited to, statements about:
•
our entrance into an Agreement and Plan of Merger (the "Merger Agreement") with Beacon Parent Holdings, L.P., a Delaware limited partnership ("Parent"), and Beacon Merger Sub, Inc., a Delaware corporation ("Merger Sub"), including our beliefs about the potential benefits of the transaction contemplated by the Merger Agreement; and the planned completion and timing of the transaction contemplated by the Merger A"
"•
Among other potential adverse events, insertional oncogenesis is a significant risk of gene therapies using viral vectors that can integrate into the genome."
"Business
Overview
We are a biotechnology company committed to commercializing potentially curative gene therapies for severe genetic diseases based on our proprietary lentiviral vector (“LVV”) gene addition platform."
"These forward-looking statements include, but are not limited to, statements about:
•
our plans and expectations regarding our commercialization activities for SKYSONA, ZYNTEGLO, and LYFGENIA, as well as any future approved products and the timing or success thereof, including expectations regarding our network of qualified treatment centers;
•
the initiation, timing, progress and results of our preclinical and clinical studies, and our research and development programs;
•
our ability to advance"
"•
Among other potential adverse events, insertional oncogenesis is a significant risk of gene therapies using viral vectors that can integrate into the genome."
"The Company is a biotechnology company committed to researching, developing and commercializing potentially curative gene therapies for severe genetic diseases based on its proprietary lentiviral vector ("LVV") gene addition platform."
"These forward-looking statements include, but are not limited to, statements about:
•
our plans and expectations regarding our commercialization activities for SKYSONA, ZYNTEGLO, and LYFGENIA, as well as any future approved products and the timing or success thereof, including expectations regarding our network of qualified treatment centers;
•
the initiation, timing, progress and results of our preclinical and clinical studies, and our research and development programs;
•
our ability to advance"
"•
Among other potential adverse events, insertional oncogenesis is a significant risk of gene therapies using viral vectors that can integrate into the genome."
"The Company is a biotechnology company committed to researching, developing and commercializing potentially curative gene therapies for severe genetic diseases based on its proprietary lentiviral vector ("LVV") gene addition platform."
"These forward-looking statements include, but are not limited to, statements about:
•
our plans and expectations regarding our commercialization activities for SKYSONA, ZYNTEGLO, and LYFGENIA, as well as any future approved products and the timing or success thereof, including expectations regarding our network of qualified treatment centers;
•
the initiation, timing, progress and results of our preclinical and clinical studies, and our research and development programs;
•
our ability to advance"
"•
Among other potential adverse events, insertional oncogenesis is a significant risk of gene therapies using viral vectors that can integrate into the genome."
"The Company is a biotechnology company committed to researching, developing and commercializing potentially curative gene therapies for severe genetic diseases based on its proprietary lentiviral vector ("LVV") gene addition platform."
"Generally Accepted Accounting Principles (“US GAAP”) in connection with the Company's accounting for lease arrangements, including certain arrangements with contract manufacturing organizations (“CMOs”) and a contract testing organization (“CTO”) that are deemed to contain one or more leases for accounting purposes."
"These forward-looking statements include, but are not limited to, statements about:
•
our plans and expectations regarding our commercialization activities for SKYSONA, ZYNTEGLO, and LYFGENIA, as well as any future approved products and the timing or success thereof, including expectations regarding our network of qualified treatment centers;
•
the initiation, timing, progress and results of our preclinical and clinical studies, and our research and development programs;
•
our ability to advance"
"•
Among other potential adverse events, insertional oncogenesis is a significant risk of gene therapies using viral vectors that can integrate into the genome."
Source: SEC EDGAR · Retrieved Oct 06, 2026
Frequently Asked Questions About bluebird bio Manufacturing
What is bluebird bio Manufacturing's CDMO Signal Score?
bluebird bio Manufacturing has a Signal Score of 78/100, based on quality, operations, financial stability, and capacity data.
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