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Biopharma Technology LLC vs Viralgen

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CategoryBiopharma Technology LLCViralgen
Listed sitecdmocdmo
SummaryUSA-based CDMO specializing in lyophilization R&D, formulation development, and small-batch manufacturing for pharma and diagnostics with 35+ years of industry experience and ISO 13485 & ISO 9001 certification.Viralgen is a CDMO specializing exclusively in cGMP AAV gene therapy manufacturing, with the world's largest dedicated AAV production capacity and a 100% success rate for IND/IMPD dossiers across 50+ gene therapy customers.
Services
  • Analytical Method Development & Validation
  • ICH Stability Studies
  • Analytical Method Development & Validation
  • Regulatory Affairs
  • EU EMA Regulatory Strategy
  • US FDA Regulatory Strategy
ModalitiesData not yet provided.
  • AAV / Viral Vector Platform
  • Gene Therapy
IndicationsData not yet provided.
  • Rare Disease
Locations
  • Headquarters, Carlsbad, California, USA
  • Headquarters & Manufacturing, San Sebastián, Basque Country, Spain
Certifications
  • ISO · Identifier: ISO 13485
  • ISO · Identifier: ISO 9001
  • EMA · Identifier: AEMPS/EMA certified
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.