ElevateBio BaseCamp

Waltham, MA

AAV Lentiviral CAR-T

Program data pending ClinicalTrials.gov matching · Last scored 2026-04-29

59.0

Signal Score

○ FDA Inspections ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: ElevateBio BaseCamp

Signal Score: 59.0/100 (as of 2026-04-29)
Quality Compliance: Assessment pending
Headquarters: Waltham, MA
Modalities: AAV, Lentiviral, CAR-T
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

Pure-play CDMO.

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 —

No ClinicalTrials.gov facility matches confirmed for this manufacturer.

Programs — no verified data

Sponsors— no verified data

ModalitiesAAV, Lentiviral, CAR-T

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

Profile-based financial assessment

SEC FilingsPrivate company

Private company

Financial assessment: 60.0/100

Capacity

1 manufacturing site

1 manufacturing site: Waltham, MA

Modalities: AAV, Lentiviral, CAR-T

Capacity assessment: 58.0/100

Moderate (3) CAPA 2025-09-26 21 CFR 111.503

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."
Minor (2) Documentation & Records 2025-09-26 21 CFR 111.70(e)

Specifications - finished dietary supplement

"You did not establish product specifications for identity, purity, strength, composition and limits on contamination."
Minor (2) Personnel & Training 2025-09-26 21 CFR 111.155(c)(3)

Quality control - components, approve, release

"Your quality control personnel did not approve components while the components were quarantined and release components from quarantine for use in the manufacture of a dietary supplement."