Protease-Free Certification

Protease-Free Certification
This test certifies any of a wide variety of products to be free of protease contamination.
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Service Description


  • Experienced - MO BIO has over 22 years of experience in providing Protease-free certifications to many major medical device companies and suppliers of plastic consumables
  • Qualified - All MO BIO Services technicians receive extensive training and are qualified to test raw materials or end products for the presence of Proteases
  • Certified - MO BIO is ISO 9001:2008 certified for providing 3rd party independent laboratory testing services for the life science industry

A protease is any enzyme that performs proteolysis via hydrolysis of the peptide bonds that link amino acids together in a polypeptide chain. Protease contamination is of great concern in the medical device and pharmaceutical industries as well as the biotech and research fields, because it can result in degradation of valuable protein samples, which may render them unusable in applications such as PAGE, western blotting, 2D Gel electrophoresis and mass spectrometry.

Certifying products protease-free has become a common practice among general laboratory plastics manufacturers as well as medical device and pharmaceutical companies. Testing your product lines for this common contaminant will add integrity to your products and will enable a wider range of customers to utilize your products for their experiments and applications.



Protease Test Method

Test samples of the product are extracted in a protease-free solution and a portion of the extract is incubated with a protease substrate. Negative and positive controls are run with the test sample extract to verify the experimental procedure and technique. The extract solution is used to represent the negative control. Proteinase K is exposed to the protease substrate in various concentrations to represent the positive control.

All samples are incubated overnight for 18 hours at 37˚C. The samples and controls are then incubated at 4˚C for 30 minutes. After the incubation period, the pH of all samples and controls are adjusted. Hydrolysis of the casein releases azo dye into the media where it is detected upon pH change. The test samples and the negative control should exhibit no color change. The positive control should have color change, indicating the effect of protease contamination on the substrate used for all samples.

Passing test criteria: The protease substrate exposed to the test sample extract must look exactly the same as the substrate negative control that was exposed to the protease free extract solution. The negative control must not have any protease activity. The positive control must show a color change for the test to be valid.

Test sensitivity: 6 ng

Contact Services

Contact Services

MO BIO Laboratories Inc. has over 22 years of experience in providing services that keep your products competitive and in demand. Our customers include many of the top plastics and medical device suppliers in the industry. As an ISO 9001:2008 certified company, MO BIO is committed to delivering the highest quality testing services to our customers. Our services specialists can also work with you to develop a custom testing schedule and/or custom tests that fit the specific needs of your products. MO BIO is located in Carlsbad, CA, USA.