Proteinase K, rec., PCR Grade, sol.

from Titrirachium album, expressed in Pichia pastoris, solution

Proven performance in diagnostics and pharma

For DNA or (m)RNA isolation, Proteinase K is the enzyme of choice to remove proteins that are still present adjacent to the nucleic acids. For about 20 years, Roche has been producing this enzyme from a recombinant organism and making it available in a highly reproducible quality that became the gold standard in the industry.

Special emphasis was placed on the testing for contaminating impurities, such as nucleases and DNA. Designed fit-for-purpose to isolate nucleic acids, Roche CustomBiotech Proteinase K, PCR Grade, provides the performance, quality, and scale you need.

We have designed our manufacturing process from the master cell bank to final QC-release to exclude or minimize potential contaminants, thereby reducing overall process risk and simplifying procedures for regulatory approval.

produced using validated manufacturing and cleaning processes up to the final filling step. Except for the hemoglobin-based activity assay, the products is released using validated QC methods. Know that you are getting consistent quality every time.

the product is manufactured without using any animal, human or cell culture derived material from TSE-relevant animal species acc. to EMA/410/01 Rev. 3. A statement regarding TSE/BSE and viral safety is available.

during fermentation, no antibiotics are used. Therefore, allergic reactions to antibiotics is not a factor in your overall risk analysis.

tested during final QC-release for the absence of impurities such as nucleases, DNA, and bioburden. Work with an enzyme at peak performance that poses no risk to downstream processing.

We work with you to provide the necessary technical documents for your regulatory submissions.

Changing reagent quality between pre-clinical development and commercialization poses a risk. Secure your processes by using the best available quality from the start.

Reach out to your regional CustomBiotech representative for more information
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Technical documents

for certificates, method sheets (instructions for use), safety data sheets and software downloads
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