Frequently Asked Questions – Raw Materials

Q. Does Genzyme Diagnostics only manufacture enzymes?

A. No, Genzyme Diagnostics also manufactures chemical substrates and antibodies in the intermediates product line, as well as formulated reagents and rapid tests.

Q. What does enzyme activity mean?

A. Enzyme activity is a measurement of how potent a particular enzyme is and will vary from batch to batch for the same enzyme even when using the same methodology for assigning an activity value. All of our enzymes have a guaranteed minimum activity specification; however for each batch of enzyme an actual activity will be assigned and quoted on a Certificate of Analysis. When enzymes are used in diagnostic reagents they are added to reagents in quantities based on activity, hence higher activity lots require less enzyme powder to be added. Enzyme powder is a mixture of enzyme protein plus additives such as buffer salts, preservatives and/or stabilizers.

Activity measurements are reported in units per mg powder and usually state the assay conditions used, especially the temperature. Different assay methods usually produce different activities, so care should be taken when comparing activity measurements.

Activity is also sometimes referred to as concentration.

Q. What is specific activity?

A. Specific activity is a measure of activity that only takes into account activity by actual protein in the powder. If a powder is 60% protein (or 60% pure enzyme), then the activity per mg of protein will be higher than the stated activity per mg powder. The percent protein must be known to determine the specific activity, which is why protein is normally reported on the enzyme certificate of analysis. Specific activity is normally expressed in XX units/mg of protein. This is dependent on the determination method and the temperature at which the test was run.

Specific activity is simply a different way of expressing the activity measurement of an enzyme. As stated in the answer to the question above, enzyme activity is a measurement of how potent an enzyme is when in a powder formulation with additives. Specific activity expresses the same enzyme activity value but takes into account the protein content of the enzyme powder. Protein values are routinely determined for all enzyme preparations and are quoted on the Certificate of Analysis. Using the activity measurement and protein value, the specific activity can be calculated and expressed as units per mg of protein. Specific activity values are only directly comparable when the same assay conditions are used for measurement of enzyme activity.

Q. What are contaminants?

A. Contaminants are interfering substances that may occur in enzyme preparations. They are generally at very low levels. Enzymes are manufactured from mixtures of biological fluids using biochemical purification methods. The contaminants we measure are often those that would interfere with the reagent systems that they are commonly used in. The purification processes are tailored to remove these materials. Contaminating substances, which are frequently enzymes, have defined maximum levels and are always specified on the Certificate of Analysis.

Q. Do enzymes have expiration dates? How long can they be used?

A. Our enzymes are provided with Certificate of Analysis, which states a date of analysis for that product and its stability under defined storage conditions. After this period a retest would be recommended to ensure that the enzyme has maintained the same level of activity.

Q. When Bovine Serum Albumin (BSA) is used as a stabilizer in an enzyme preparation, what source of BSA is used?

A. Any BSA that is used in the manufacture of Genzyme products is sourced from suppliers who certify the material to be free from bovine infectious diseases, in particular Bovine Spongiform Encephalopathy (BSE).

Q. What is a recombinant enzyme?

A. A recombinant enzyme is an enzyme that has been genetically modified to be expressed in a microbial host. Generally recombinant enzymes have a higher activity and purity when compared to the native enzyme.

Q. How do you compare different assay units for the same enzyme?

A. Enzyme assays are performed under strictly defined conditions. Direct comparison of enzyme units under different assay conditions is difficult. Genzyme would recommend that for specific applications it is best to obtain a sample of the product of interest to assess its suitability and optimize its use in your formulation.

Q. What special measures are required when purchasing animal derived products?

A. Genzyme provides a range of enzyme from microbial sources. However, the use of animal derived products is appropriate for some applications. In these cases Genzyme can provide Certificates of Origin and provide import/export advice.

Q. Can Genzyme’s products be used in food production?

A. Genzyme’s products are manufactured to the quality and procedures required for In Vitro Diagnostic use only and are not intended for use in food production.

Q. Can Genzyme manufacture a specific diagnostic enzyme for my needs?

A. Genzyme has over two decades of scientific experience in research, scale-up and commercial production of enzymes. Please contact your Genzyme representative to discuss specific enzymes for your needs.

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