Cumplimiento regulatorio: Escalado gestionado conforme a normas regulatorias globales para la producción de biológicos y vacunas de base mamífera y microbiana
Tiempo de entrega: Los sistemas modernos de un solo uso y un equipo técnico experimentado permiten un tiempo de respuesta rápido, escalabilidad y consistencia lote a lote
Experiencia en área terapéutica: Plataformas de producción de base mamífera y microbiana para proteínas terapéuticas, anticuerpos monoclonales, enzimas y candidatos a vacunas

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KBI Biopharma provides flexible, phase-appropriate clinical manufacturing to advance biologics and vaccines from early through late-stage trials, using a US-based network of cGMP facilities covering both mammalian- and microbial-based production of therapeutic proteins, monoclonal antibodies, enzymes, and vaccine candidates. Whether processes are developed internally or transferred from clients, the company manages scale-up against global regulatory standards using modern single-use systems and an experienced technical team for fast turnaround, scalability, and lot-to-lot consistency, with services spanning clinical drug substance manufacturing, drug product support, release and stability testing, tech transfer/scale-up, and regulatory documentation support.