Andelyn Biosciences has the ability to support Phase III programs as of 2020.
The company has expanded its capabilities to offer both adherent and suspension mode manufacturing up to 200L scale.
Andelyn Biosciences is targeting 2022 for the completion of a new state-of-the-art cGMP manufacturing facility capable of early stage development through commercial scale production (pictured bottom left). The 200,000 square foot building will house 8 suites with capacity up to 2,000L SUB. Until then, all Andelyn labs and manufacturing suites are housed in the Abigail Wexner Research Institute at Nationwide Children’s (pictured bottom right).
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- 130+ employees and growing
- 15+ years’ experience manufacturing AAV viral vectors
- Full spectrum QC/QA
- Plasmid Manufacturing expertise
- Sixty 36 layer HYPERStacks per sublot
- 50L, 200L suspension bioreactors (SUB)
- Multiple, concurrent sublot productions
- 60+ IND clinical trials supported in the US/EU/ROW
- First release of a gene therapy for clinical use in 2011
- 15+ years’ experience process development/process characterization
- Product development history with multiple serotypes and purification processes