Arranta is more than a CDMO; we are a strategic partner, teaming up with innovators and aligning with their vision to unlock the potential of advanced therapies and to bring those therapies from labs to patients.

Whether your company is a new innovator, a mid-sized biotech, or a large pharma, Arranta is your partner for every step of the journey from process development through clinical supply to commercial manufacturing, offering:

• Analytical Development, Qualification, and Validation
• Live Biotherapeutic Product Process Development
• Live Biotherapeutic Product Pre-clinical, Clinical and Commercial Drug Substance and Drug Product Manufacturing
• mRNA Vaccine Drug Substance Process Development
• mRNA Vaccine Pre-clinical, Clinical and Commercial Manufacturing (including plasmid, mRNA, and lipid nanoparticle, and aseptic fill/finish)

Our capacity has been built specifically for developing and manufacturing advanced biologic therapies requiring up to BSL2 segregation… and it’s available now. Arranta has a deep commitment to build and operate the state-of-the-art facilities needed to support complex manufacturing processes for clients.

• Purpose-built cGMP Manufacturing facilities in compliance with:
  • • FDA Code of Federal Regulations (Part 21)
    • ICH Guidelines
• Flexibly engineered as multi-product facility to accommodate different manufacturing technology platforms
• Facility and equipment controls to accommodate 50 g LNP production
• mRNA drug substance, LNP formulation and sterile fill/finish capabilities under one roof
• Facility engineering principles and procedural controls meet current and anticipated regulatory compliance standards
  • • Unidirectional flow of people, product, materials, & waste
    • Single use technologies
    • Complete segregation of manufacturing suites
    • HVAC isolation of air in GMP suites enabling centralized VHP decontamination of individual suites

A Quality culture and system is at the center of everything we do.

• Robust phase-appropriate Quality Management System in place
• Best-in-class Quality IT Systems in place
• We offer regulatory support to help you submit your products for licensure and to take them through the regulatory path to approval.