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 with a proven track record with GMP regulations (21 CFR 210 and 21 CFR 211).

GMP-Source™ (GMP-S) grade – A faster, cost-effective alternative to full cGMP production, (GMP-S) . Adopts the most relevant features of cGMP manufacturing, including traceability, document control and materials segregation.

GMP grade – Driven by a comprehensive quality assurance process, we produce GMP products in segregated ISO-classified manufacturing suites under a QMS certified to ISO 13485:2016 (21 CFR 820), 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-S Grade	GMP Grade
Custom Manufacturing	Traditional Plasmid DNA	X		X	X
	Nanoplasmid™ DNA	X		X	X
	RNA Drug Substance	X			X
	RNA Drug Product	X			X
	Protein/Enzymes	X	X		X
	Ribonucleoprotein (RNP) Complexes	X			X
In-stock Products	CRISPR Nucleases	X			X
	in vitro Transcription & Capping Enzymes	X			X
	Viral Vector Plasmids	X		X	X
	Cloning Backbones	X
	Reporters	X