Accurate Evaluation Decoding for Protein Derivative of BCG (BCG-PPD)

BCG-PPD is a lyophilized product made from bacillus Calmette-Guérin strains purified by cultivation, sterilization, filtration, salting out, and acid precipitation. It contains active substances obtained from bacterial culture suspensions. According to the client's needs in Pharmaceutical and Biological Analysis, we provide you with the most satisfactory and convenient analytical evaluation solutions. Moreover, we have extensive industry experience in Pharmaceutical Analysis, Biological Evaluation, and Pharmaceutical Excipient Analysis.

• Basic test
  • Our research team provides various basic tests including solubility tests, pH tests, and moisture determination services.
• Identification
  • We identify by observing the average diameter of the sclerotic reaction in BCG-sensitized guinea pigs after injection with BCG-PPD.
• Content test
  • Protein: We provide accurate protein content determination service by the Lowry method. Under alkaline conditions, phenol reagent is easily reduced by tyrosine, tryptophan, and cysteine in proteins in a blue color reaction.
  • Polysaccharide: We add glucose standard solution and BCG-PPD respectively to the anthrone mixture and test absorbance. The polysaccharide content of this product is calculated using the concentration of glucose standard solution corresponding to its absorbance.
  • Nucleic acid: We use a UV-visible spectrophotometer to test nucleic acid content.
  • Phenol: We calculate the amount of phenol in the samples by titration with sodium thiosulfate. Notably, the results of the titration are corrected with a blank test.
• Potency test
  • Diluted injection
    The standard and BCG-PPD are diluted in 3 concentrations and injected intradermally into BCG-sensitized guinea pigs. Our researchers observe the longitudinal and transverse diameters of localized sclerosis at 24 h and 48 h, respectively, and then calculate the total or average area of sclerosis response for each dilution for 2 days.
  • Direct injection
    We choose guinea pigs with appropriate body weight and sensitized by BCG to be injected intradermally with standard and BCG-PPD. Our researchers observe the diameter of the sclerotic reaction and calculate the ratio at 24 h and 48 h after the injection, respectively.
• Sensitization test
  • We choose guinea pigs that have never been tested before to set up an experimental group and a control group. The guinea pigs in the experimental group are injected subcutaneously with BCG-PPD 3 times according to the inoculation schedule. Then both experimental and control groups are injected again with BCG-PPD for 1 time. Our researchers look continuously to see if there is a significant difference.
• Sterility test and abnormal toxicity test
  • Sterility test: We provide professional sterility tests on bulk, final bulk, and final products to ensure optimum quality.
  • Abnormal toxicity test: We offer reliable abnormal toxicity tests to detect toxicity introduced during the manufacturing process or due to other causes.

Publication Data

Applications of BCG-PPD Evaluation

• BCG-PPD evaluation provides a basis for the evaluation of other protein derivatives.
• BCG-PPD analysis and evaluation have facilitated the development and design of BCG vaccines.
• BCG-PPD evaluation has a key role in cancer research such as bladder cancer and colon cancer drug development.

Advantages of US

• Our professional evaluation team possesses rich basic professional knowledge, is skilled in operating various experiments, and is familiar with the standard specifications in their fields, which enables us to accurately conduct BCG-PPD analysis and issue reports.
• For all titration and absorbance tests, our researchers conduct parallel experiments to ensure the most accurate data for our clients.
• Our lab provides a one-stop service for BCG-PPD bioactivity evaluation including animal culture, inoculation, observation of status, and calculation services.

CD BioGlyco has team members with different professional backgrounds working together to help our clients with pharmaceutical and biological analysis projects. This helps to blend different perspectives and improve analytical and evaluation capabilities. Please feel free to contact us.