Aldevron Breakthrough Blog

3 Reasons CRISPR Gene Editing Success Relies on Partnering with an Experienced Manufacturer

CRISPR/Cas9 Gene Editing

Groundbreaking technologies arise every decade or so, advancing genomics research and the development of new medicines. Restriction enzymes in the 70s, polymerase chain reaction in the 80s and next-generation sequencing in the 90s all represented huge leaps forward. Recently, however, the CRISPR revolution has shown the potential to overshadow them all.

CRISPR, or clustered regularly interspaced short palindromic repeats, is a long-sought breakthrough for making highly specific changes to genetic codes. Compared to established technologies such as zinc-finger nucleases (ZFNs) and transcription activator like effector nucleases (TALENs), the CRISPR system using Cas9 nuclease is faster, easier, more precise and more flexible.

CRISPR technology will have great impact on basic and applied life-science research. Therefore, important questions should be asked when choosing a partner that can develop and manufacture CRISPR components such as Cas9 to meet your present and future needs for Cas9 product design, scale and quality.

We’ve reviewed three important reasons why experience and expertise matters when choosing such a partner. 

1. Custom, Consistent Manufacturing Capabilities

Scaling up for clinical applications brings risks that absolutely cannot be ignored:

  • Production method should be engineered to scale.
  • Production method needs to be transferable directly to GMP manufacturing.
  • Production method must minimize lot to lot variability in performance.

The Aldevron Basis for Breakthroughs

When ready to scale up for clinical application, will your Cas9 protein supplier be ready to make the transition with you?

To avoid risks associated with such a critical transition, we provide Cas9 proteins manufactured consistently from research through preclinical and clinical applications. As your custom development and manufacturing partner for Cas9 and related nucleases, we offer a range of options:

  • Process development and production starting from a gene sequence.
  • Process development and production starting with a Client’s expression plasmid or cell paste.
  • Custom production starting from Client’s manufacturing processes.

 2. Simple and Effective Construct Design

The development of CRISPR-based gene therapies using Cas9 protein calls for products free of non-native sequences that have no purpose in your application.

Aldevron offers a selection of recombinant spCas9 proteins free of affinity, detection and solubility tags, allowing you to:

  • Avoid unintended consequences in your research or clinical application that might result from presence of affinity, detection or solubility tags.
  • Avoid divalent metal-cation contamination by using spCas9 products purified without using immobilized metal affinity chromatography (IMAC).

The Aldevron Basis for Breakthroughs

Aldevron’s offers recombinant spCas9 protein fused only to one or more copies of the seven amino acid nuclear localization signal from SV40 Large T-antigen (sv40 NLS) to facilitate nuclear import of ribonucleoprotein (RNP). Our spCas9-sv40 NLS fusion proteins are expressed and purified without extraneous, nonnative sequences such as affinity, solubility or detection tags widely used for recombinant protein production.

Click here to request a free sample of our wild-type S. pyogenes Cas9 nucleases––the best option for CRISPR-Cas9 applications.

3. Comprehensive Documentation Support

To ensure smooth and efficient transition from research into preclinical and later phases, it’s important to start with Cas9 protein manufactured strictly using animal origin-free materials or materials sourced from countries deemed BSE/TSE free.

Use of a Cas9 protein that is manufactured with animal components during the research phase may result in additional costs and time to qualify a new enzyme at later stages in the development cycle.

The Aldevron Basis for Breakthroughs

Our raw material management system assures only qualified materials are used for manufacturing. Cas9 proteins can be delivered with TSE/BSE statement as well as Certificates of Analysis and Manufacturing Summary Reports.

With over 1,000 protein lots produced, Aldevron has a record of success developing and manufacturing client sequences for Cas9 and related nucleases, and we would appreciate the opportunity to partner with you on your project.

Interested in bringing Aldevron's Cas9 proteins to your lab? Click here to request a free sample of our wild-type S. pyogenes Cas9 nucleases––the best option for CRISPR-Cas9 applications.

Want to learn more about partnering with Aldevron for your next project? Contact us today to start a conversation.

About the author

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Tom Foti

Tom Foti

Thomas Foti has more than 25 years of biotechnology experience and serves as Vice President/GM of the Protein Business Unit. He was one of the original founders of Aldevron’s protein services business, which was formed in 2009. Prior to working for Aldevron, Foti served in several roles in the Merck KGaA Bioscience Division, most recently as the Director of its Global Custom Services Business. He started his career in 1992, with Novagen, Inc. serving in manufacturing and operational roles until 1999. He played college basketball while earning a Bachelor’s of Science in Biotechnology and Microbiology from North Dakota State University. Foti also holds a Master’s in Business Administration from Edgewood College and a Management Leadership Certificate from Massachusetts Institute of Technology.

Topics: Gene Editing, Protein