MOLECULAR BIOLOGY

 

DNase Detection Assay

This test will certify products to be free of DNase contamination and ready for use in experiments and applications of DNA.

The DNase Detection Assay will test for the presence of common environmental DNases (human, bacterial) and qualify products tested to be safe for use in DNA related work.  Passing lots are accompanied with a certificate of conformity.

The test is best tested in conjunction with the RNase Detection Assay.  As an indicator of the cleanliness of the manufacturing and efficacy of sterilization programs. 

DNase is a common laboratory contaminant as it is biologically active in tears, saliva, and to a minimal degree detectable on human skin.  Humans and bacteria are the primary source for deoxyribonucleases.  Precautions should be taken to ensure that glassware, solutions, reagents, workspace, tools, and gloves are free from deoxyribonuclease contamination when working with DNA. 

RNase Detection Assay

This test will certify products to be free of RNase contamination and ready for use in any experiments and applications of RNA.

The RNase Detection Assay will test for the presence of common environmental RNases (human, bacterial, and viral) and qualify products tested to be safe for use in RNA related work.  Passing lots are accompanied with a certificate of conformity and considered to be RNase Free below a 10-11 Kunitz Units sensitivity.  

 

The test is commonly tested in conjunction with the DNase Detection Assay  as an indicator of the cleanliness of the manufacturing and efficacy of sterilization programs. 

The ubiquity of RNase is a huge concern for researchers in RNA work.   It's pervasiveness  as environmental contaminant can be attributed to humans.  It is exuded from the sebaceous oils of the human epidermis and are the primary source for ribonucleases.  Environmental contamination is also of great concern, as micoorganisms are a significant contributor as well to RNase.  RNase is a robust enzyme capable of withstanding prolonged sterilization and resistant to chemical inactivation.   Therefore it is of the utmost importance that precautions should be taken to ensure that glassware, solutions, reagents, workspace, tools, and gloves are free from ribonuclease contamination when working with RNA. 

DNA Detection Assays

Certify any  product to be free of certain types of DNA and common contaminants and inhibitors that interfere with the PCR process.

 

The suite of DNA Detection Assays will test for the presence of DNA from common contaminants on the manufacturing environment, they include human, mouse, rat, bacteria.   The assays will qualify products tested to be safe for use in DNA related work.  Passing lots are accompanied with a certificate of conformity.

 

The detection assay will also quantify to a certain level of assurance lack of inhibitors and common contaminants which will interfere with PCR reactions and processes.  See qPCR inhibition test to quantify PCR inhibition levels. 

The test is commonly tested in conjunction with the RNase and DNase Assays to complement a products use in the molecular and forensics field.  DNA Free products assure end users the cleanliness of manufacture and the efficacy of sterilization programs.

qPCR Inhibition

This test will certify your products to be free of PCR inhibitors.  

 

PCR, RT-qPCR and qPCR are extremely sensitive enzymatic reactions.  Polymerase activity, primers, pH, nucleotides and ionic concentrations are all carefully controlled components of a PCR reaction mix.  These optimized components and conditions are very sensitive to leachates, extractables, and other inhibitors used within the setup of a PCR reaction.  

Endotoxin/Pyrogen Testing

This certification certifies any of a variety of products to be free of contaminating endotoxins or quantifies endotoxin levels. 

 

The Endotoxin Detection Assay tests for gram negative endotoxins.  The assay follows current USP chapter <85> and AAMI ST72:2013 guidelines to qualify products are below specified levels of endotoxin.   Passing lots are accompanied with a certificate of conformity.  

Endotoxins/Pyrogens are ubiquitous as they are components of lysed bacterial cell walls.    Bacteria will be present in any laboratory or manufacturing environment.  Stringent control of manufacturing environments and human personnel is required to keep endotoxin/pyrogen levels low.    

Protease Detection Assay

Test products to be free of Proteinase contamination.

Proteases are a primary concern for reagent manufacturers, biologics, and enzyme producers.  Buffers and containers used in the storage of enzymatic proteins and biologics is important to be tested for Protease contamination.  

 

Enzymes themselves need to be tested for the presence of protease.  A majority of enzymes produced are cloned in bacterial hosts.   It is important to test that proteases from these host organisms are not transferred over during production and purfication.  

 

Endonuclease Detection Assay

Test products for presence of contaminating endonucleases such as restriction enzymes and nickases.

Exonuclease Detection Assay

Test products for Exonuclease contamination.

Phosphatase Detection Assay (ALP)

Test products to be free of Phosphatase contamination.

In biotech, pharma, food, research and life sciences; extraneous phosphatases are detrimental contaminants in a researchers workflow.  Primarily, alkaline phosphatase (ALP) are of great concern in immunoassays (ELISA, histochemistry).  These assays are notably sensitive to experimental conditions.

 

Interference from bacterial ALP, is common in water systems, buffers, and laboratory consumables.  ALP testing and routine monitoring of water systems, manufacturing environments, and life science consumables are important in the control of microbial ingress.  

Mycoplasma Detection Assay

Verify products and cell lines to be free of Mycoplasma contamination.

Mycoplasma contamination of cell lines is one of the major problems in cell culturing and cell culture maintenance.  Specific, sensitive, and reliable detection of mycoplasma contamination is an important part of mycoplasma control .

 

New cell lines as well as cell lines in continuous culture must be tested in regular intervals. We use PCR methodology over traditional culture based methods to deliver fast and sensitive technique to detect mycoplasma contamination.

 

The technique can also be used to determine the mycoplasma down to species level if requested (additional time and costs).  

Protein Detection Assay

Test and Certify products to be free of contaminating Proteins.

ATP Detection Assay

Test and certify products to free of ATP Contamination.

ATP is present in all living cells.  With microorganisms and cellular debris in high abundance in the environment, testing contamination in a manufacturing environment is vital for ensuring proper gowning, handling, and cleaning procedures are effective.

 

The presence and amount of ATP is an indication of the level of purity of that product.  During the manufacturing process, human handling of and exposure to manufacturing materials and machinery, creates opportunities for product contamination to occur.  ATP’s presence on manufactured products is indicative of cellular contamination resulting from contact with humans (saliva, hair follicles, nasal cavity, finger tips, ear canal), food residues, water, soil, animals, or other biological sources.

USP Heavy Metals Testing

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