Phase-Appropriate Quality Grades

The right product at the right time

You are embarking on a new therapeutic or diagnostic development journey. You must balance numerous variables to maximize your chances of success. This includes critical decisions from the earliest phases regarding the quality level of catalog and custom-manufactured products.

If your product choices in the early phases can’t grow with you, either in quality or quantity, you may face rework, technology/process transfers, or other costly delays. Therefore, Aldevron provides the same products at phase-appropriate quality levels to scale with your needs:

Research grade – Appropriate for a variety of research and pre-clinical applications, providing affordable, high-quality DNA, RNA, or protein.

For Molecular Diagnostics (MDx) use – Manufactured in our ISO13485 certified facility.

GMP-Source™ – A faster, cost-effective alternative to full cGMP production, GMP-Source adopts the most relevant features of cGMP manufacturing, including traceability, document control and materials segregation.
GMP-Grade* – Appropriate for ancillary materials intended for further manufacturing within cGMP settings, GMP-Grade offers highly characterized products made under a robust QMS certified to ISO 13485:2016 standards.
cGMP – Driven by a comprehensive quality assurance process, we produce cGMP products in segregated grade-classified manufacturing suites under compliance with 21 CFR 210 and 21 CFR 211, ensuring the highest quality products with each order.

The following Aldevron products are available in the following quality grades:

		Research Grade	For MDx use	GMP-Source	GMP-Grade	cGMP
Custom Manufacturing	Traditional Plasmid DNA	•		•		•
	Nanoplasmid™ DNA	•		•		•
	Alchemy™ Cell-free DNA	•
	RNA Drug Substance	•				•
	RNA Drug Product	•				•
	Protein/Enzymes	•	•			•
	Ribonucleoprotein (RNP)** Complexes	•				•
Catalog Products	CRISPR Nucleases	•				•
	in vitro Transcription & Capping Enzymes	•			•	•
	Viral Vector Plasmids	•		•		•
	Cloning Backbones	•
	Reporters	•

* GMP-Grade is a branding term used by Aldevron to describe products manufactured and released at Aldevron's Madison Innovation campus which operates in compliance with ISO 13485 quality management system standards. Materials under this branding term are intended for further processing as Ancillary Materials, Process Reagents and Raw Materials to produce cell-based and gene therapy products. These materials are neither present in the final product nor administered to humans or animals. It is the sole responsibility of the purchaser and their customers to evaluate the use of GMP-Grade material for their intended use and to ensure compliance with applicable regulatory or legal requirements.
** Aldevron provides RNPs only to customers who are duly licensed, including to make and have made RNPs, for their intended use.