Developing and manufacturing biological drug substances that fall under Biosafety Level 3 classification requires a very specific infrastructure — one that combines the containment standards of a BSL-3 facility with the documentation, process control, and quality systems of GMP manufacturing. Finding both under one roof, available to external sponsors, is rare in Europe.
At Archivel, our BSL-3 GMP suite was designed precisely for this gap — providing clinical-stage sponsors working with Group 3 biological agents access to a fully compliant, GMP-certified manufacturing environment, integrated within our broader biologics facility in Barcelona.
