Aldevron

Overview

Aldevron is a contract development and manufacturing organization (CDMO) offering comprehensive manufacturing solutions and regulatory support for viral and non-viral vector therapies, mRNA therapeutics, and gene editing applications. The company provides services spanning discovery through clinical trials to commercialization, with established workflows for both custom manufacturing and catalog products.

Core Service Areas

mRNA & RNA Therapeutics

• Complete mRNA custom manufacturing with LNP encapsulation and fill/finish capabilities
• In vitro transcription and capping enzymes (Codex® HiCap RNA Polymerase)
• RNA vaccine and therapeutic development
• Drug substance manufacturing, analytics, and quality control under one quality system

Gene Therapy & Viral Vectors

• Plasmid design expertise (traditional and next-generation Nanoplasmid)
• Process development and QC for viral and non-viral gene therapy applications
• AAV and lentiviral vector plasmid manufacturing
• Viral expression and helper plasmids for high-titer vector generation

Gene-Modified Cell Therapy

• Custom lentiviral plasmid manufacturing
• Standardized ALD-Lenti System packaging plasmids

Gene Editing

• CRISPR nucleases (high-fidelity and wild-type) at research and cGMP grades
• Support for ex vivo and in vivo gene editing programs
• Custom and catalog nucleases and gRNA products

Plasmid DNA Manufacturing

• Research-grade plasmid DNA maxi preps (48-hour turnaround)
• Targeted and batch plasmid deliverables
• GMP-Source™ and cGMP-grade options
• Alchemy™ cell-free DNA technology

Regulatory & Development Support

Aldevron provides analytical method development, process characterization, CMC support, IND and regulatory guidance, and PSQ experience to support clients from preclinical through commercialization phases. The company emphasizes comprehensive capabilities beyond manufacturing, including process design and late-phase/commercialization readiness to avoid costly technology transfers.