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"StructureNodeID": "02-0090", "StructureGroupPath": "CustomBiotech->Vaccine Testing", "StructureGroupName": "Vaccine Testing" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Proteinase K, recombinant, PCR Grade, digests proteins very efficiently. It can be used to rapidly inactivate endogenous RNases and DNases during nucleic acid isolation or remove enzymes that have been used during (m)RNA synthesis by in vitro transcription, as in the manufacture of mRNA vaccines.
Proteinase K is also used to:
  • Isolate native RNA and DNA from tissues and cell lines by promoting cell lysis
  • Analyze membrane structures by modifying proteins and glycoproteins on cell surfaces
  • Remove cellular debris during the preparation of colony lifts
  • Treat tissue sections to ensure efficient probe infiltration during in situ hybridization
", "Name": "Applications" }, { "Language": "en", "Value": "Recombinant Proteinase K in PCR Grade quality is a universal tool to remove proteins from DNA or (m)RNA preparations.", "Name": "Positioning" }, { "Language": "en", "Value": "Will be supplied as \"Proteinase K, rec., PCR grade, solution\". Unit of measure is \"L\".
 ", "Name": "CB - Order Information" }, { "Language": "en", "Value": "
  • Maximize the yield of target nucleic acids.
    Proteinase K is rigorously tested for the absence of nucleases.
  • Experience stability and safety.
    The solution is very stable and can be stored at room temperature for at least 18 months. The handling of the solution is safe and flexible.
", "Name": "Benefits" }, { "Language": "en", "Value": "Appearance: Clear, colorless solution
Volume activity (+37°C, hemoglobin): ≥600 U/mL
Specific activity (+37°C, hemoglobin): ≥30 U/mg protein
Unit definition (hemoglobin): One unit is the enzyme activity which releases folin positive amino acids and peptides equivalent to 1 μmol of tyrosine in 1 minute under the test conditions at 37°C.
Volume activity (+25°C, Chromozym): ≥50 U/mL
Specific activity (+25°C, Chromozym): ≥2.5 U/mg protein
Unit definition (Chromozym): One unit is the enzyme activity which cleaves 18 mmol Chromozym TRY in 1 minute at +25°C.
Protein (Biuret): 14.0-22.0 mg/mL
Unspecific endonucleases (MWM III DNA): Not detectable in up to 200 μg after 16 hours incubation at +37°C.
Nicking activity (pBR322 DNA): Not detectable in up to 200 μg after 16 hours incubation at +37°C.
Ribonucleases (MS2 RNA): Not detectable in up to 40 μg after 16 hours incubation at +37°C.
DNA (Threshold®): ≤10 pg/mg enzyme
Bioburden: ≤5 CFU/mL
Stability: At +2 to +8°C within specification range for 18 months.", "Name": "Specification" }, { "Language": "en", "Value": "Proteinase K, originally isolated from the mold Tritirachium album, is a recombinant enzyme expressed in Pichia pastoris.It is a highly active, unspecific subtilisin-related serine endopeptidase.
EC Number: 3.4.21.64
CAS Number: 39450-01-6
Molecular weight: 28.8 kD
pH optimum: 7.5-10.5
Inhibitors: Proteinase K is inhibited by diisopropyl fluorophosphate and phenylmethylsulfonyl fluoride (PMSF) and is also totally inactivated by mercuric ions. Pefabloc® SC and Pefabloc® PLUS are specific, irreversible and nontoxic inhibitors.
Specificity: Proteinase K is one of the most active endopeptidases known without any pronounced cleavage specificity. Activity can be stimulated by addition of denaturing agents (SDS and urea).
Stability: Even at room temperature, the solution is very stable and can be stored for at least 18 months.", "Name": "Properties" } ] } } ] }

Proteinase K, recombinant, PCR Grade

from Titrirachium album, expressed in Pichia pastoris, solution

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mrna

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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