COBO-Q Newsletter - Quality Control Genome Editing (June 2019) - Cobo Technologies
 
 
 
 
 
 
 
 

COBO-Q Newsletter June 2019

COBO-Q will give you the latest updates about InDel profiling using the IDAA method, proteomic expression analysis powered by SWATH LC-MS and EU/US regulations within the field of genome editing.

COBO-Q is the newsletter from COBO Technologies - a fast-growing Danish company located in Copenhagen, Denmark, specialised in products and services for Quality Control Genome Editing.

 
 
 
 
 

Corporate News

 
 
 
 
 

COBO Technologies Member of the NIST Genome Editing Consortium in US

COBO Technologies Member of the NIST Genome Editing Consortium in US

National Institute of Standards and Technology (NIST), the US reference lab for biological measurements, launched the Genome Editing Consortium in January 2018 to develop measurements and standards to increase confidence in the use of these techniques for health care, agriculture, chemical production, and other fields of national importance. As member of the NIST Genome Editing Consortium, COBO participated in the yearly workshop on May 3rd, 2019 on the NIST campus in Gaithersburg, Maryland. The consortium addresses the measurements and standards needed to increase confidence and lower the risk of utilizing genome engineering technologies in research and commercial products.

COBO will support to consortium with knowlegde and services related to InDel analysis using the IDAA method.

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Product and Services

 
 
 
 
 

PROFILase - New PCR Master Mix Optimised for InDel Profiling using IDAA Method

COBO Technologies proudly announces release of PROFILase 2x Master Mix, which is specifically formulated for IDAA tri-primer amplification and complex InDel profiling.

PROFILase 2x Master Mix is an all-in-one 2x master mix based on a Hot Start DNA Polymerase modified from Taq DNA polymerase. The unique enzyme formulation features a convenient reaction set up at room temperature with significantly reduced handling time, increased reproducibility, specificity, sensitivity and product yield.

Importantly, PROFILase 2x Master Mix has been optimized to reduce so called 3’-amplicon non-template dependent base additions and minimize formation of non-specific product.

PROFILase 2x Master Mix is ideally suited for sensitive and quantitative InDel profiling of genome editing outcomes in cells, tissues and whole organisms, using the powerful IDAA method.

PROFILase - New PCR Master Mix Optimised for InDel Profiling using IDAA Method
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PIPPR - Proteomic Expression Analysis of CRISPR modified cells

PIPPR is COBO Technologies new QC platform for detailed protein/proteome expression analysis of cells modified with any of the nuclease tools; CRISPR-Cas9, Meganucleases, ZFNs or TALENs.

Using the powerful SWATH LC-MS approach, PIPPR will offer you fast, robust and cost-effective identification and quantification of potential any protein expressed in the cell. Use PIPPR to confirm knockout of your protein of interest, do detailed expression analysis between wt and modified cells, complexed off-target analysis or investigate specific pathways or protein families.

Just ship total proteins extracted from your cells and you will receive protein expression report within only 4-6 weeks.

PIPPR Standard Service (incl. 2.000-2.500 proteins) is available now.

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Recent Publications

 
 
 
 
 

Improved CRISPR-Cas9 Gene Editing by Fluorescence Activated Cell Sorting of Green Fluorescence Protein Tagged Protoplasts.

This publication presents a plant CRISPR-Cas9 procedure that resulted in a 3–5 fold (from 20 to 30% in unsorted to more than 80% in sorted) increase in mutation frequencies as evidenced by Indel Detection by Amplicon Analysis (IDAA), which allows for high throughput profiling and quantification of the generated mutations.

Petersen BL, Möller SR, Mravec J, Jørgensen B, Christensen M, Liu Y, Wandall HH, Bennett EP and Yang Z. BMC Biotechnology (2019) 19:36,

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Fast and Quantitative Identification of Ex-Vivo Precise Genome Targeting-Induced InDel Events by IDAA.

This publication provides a protocol that is based on complexed Cas9/gRNA RNPs delivered to primary peripheral blood mononuclear cells (PBMCs) isolated from healthy individuals followed by sensitive and quantitative Indel Detection by Amplicon Analysis (IDAA), InDel profiling. Importantly, the protocol describes benefits from a short "sample-to-data" turnaround time of less than 5h. Thus, this protocol describes a methodology that provides a suitable and effective solution to validate and quantify the extent of ex-vivo CRISPR-Cas9 targeting in primary cells.

König S, Yang Z, Wandall HH, Mussolino C, Bennett EP. Methods Mol Biol. 2019;1961:45-66.

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EU/US Regulations, Guidelines and Standards

 
 
 
 
 

Introduction to U.S. Regulation for use of CRISPR-Cas9 in Pharmaceutical Clinical Research

Although CRISPR-Cas9 technology is still in its infancy, a rapid increase is expected in the scale, scope, complexity, and development rate of biotechnology pharmaceutical products enabled by CRISPR-Cas9 - over the next few years. The drug products will have to go thru clinical trial before they can be marketed.

The current system for regulating biotechnology products—the Coordinated Framework for the Regulation of Biotechnology—may be inadequate for this new technology.

Therefore U.S. Congressional Research Service has published a paper “Advanced Gene Editing: CRISPR-Cas9, December 7, 2018” discussing some aspects associated with regulation for CRISPR-Cas9. In this publication the current regulation is outlined: “The fundamental federal guidance for regulating biotechnology products, including those developed using CRISPR-Cas9, is the Coordinated Framework for the Regulation of Biotechnology (the Coordinated Framework) originally published in 1986 by the White House Office of Science and Technology Policy (OSTP). A key principle in this regulatory structure is that genetically engineered products should continue to be regulated according to their characteristics and unique features, not their production method—that is, whether or not they were created through genetic engineering techniques (e.g., CRISPR-Cas9, ZFNs, and TALENs). The framework provides a regulatory approach intended to ensure the safety of biotechnology research and products, using existing statutory authority and previous agency experience. The Coordinated Framework consists of three primary agencies—the Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the Food and Drug Administration (FDA).”

FDA is the regulating agency for clinical trials for pharmaceutical drug products.

“FDA protects human health and safety by regulating human and animal drugs, human and animal foods derived from genetically engineered plants, and genetically engineered animals under the authorities of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act (42 U.S.C. §201 et seq.).”

“FDA regulatory requirements apply to all clinical research, regardless of funding source that is carried out to investigate new, unapproved medical products such as drugs, devices, and biologics. Although FDA has not yet reviewed and approved or disapproved a CRISPR-Cas9 application, CRISPR-Cas9 products would meet the definition of a human gene therapy product and are biologics. In this case, clinical research with CRISPR-Cas9 products requires FDA acceptance of an IND; this regulatory requirement derives from FDA’s authority to regulate biologics. Biologics must receive a license (i.e., authorization) from FDA prior to being marketed.”

Today no specific new regulation is in force for clinical trials using CRISPR-Cas9. The “normal” regulation for clinical trials is to be complied to. But this can change in the future as both U.S. Congress and FDA are closely following the development of the CRISPR-Cas9 technology.

 

 

 
 
 
 
 

We will be happy to hear from you

Interested in more info about our services or products within QC Genome Editing. Please use this contact form or send email directly to: info@cobotechnologies.com.

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