The production of the lactase enzyme involves several steps, particularly when using microbial sources such as yeasts or bacteria. For yeast-based production, the process typically starts with the cultivation of lactase-producing yeast strains, such as Saccharomyces fragilis or Torulopsis spherica, in a nutrient-rich medium. This medium often includes deproteinated whey, which is a by-product of cheese production and is rich in lactose, the primary carbohydrate source for the yeast. The fermentation conditions are optimized to enhance lactase production, with factors such as temperature (usually between 80 to 100°F), pH (ranging from 3.5 to 7.5), and the presence of additional nutrients like sucrose, yeast extract, and peptone being carefully controlled[1][2].
After the fermentation process, the yeast cells are harvested and then processed to extract the lactase enzyme. This can involve various methods such as spray-drying, freeze-drying, or tray-drying to convert the yeast into a stable powder. For example, in spray-drying, the yeast slurry is fed into a spray dryer with inlet air temperatures around 200 to 310°F and outlet temperatures around 130 to 205°F. The resulting dry yeast powder is then cooled and stored to maintain its enzymatic activity. This final product is a lactase-active, zymase-inactive enzyme preparation that can efficiently hydrolyze lactose into glucose and galactose, making it useful for various industrial applications, including the production of lactose-free dairy products[3][1].
The safety profile for human consumption of lactase enzyme is generally favorable. Lactase enzyme, such as the one derived from _Aspergillus oryzae_ (GODO-FAL), has been determined to be safe and classified as Generally Recognized as Safe (GRAS) by regulatory bodies. This determination is based on extensive safety studies, including range-finding and subchronic toxicity studies in animals, which showed no adverse effects even at high doses of up to 2000 mg/kg/day. The enzyme is used in various food products, including milk, milk powder, fermented milk products, yogurt, cheese, and other dairy-based items, without any documented side effects in humans. However, rare allergic reactions can occur, and it is advised to consult a healthcare provider before use, especially for children under 4 years old or during pregnancy and breastfeeding[1][2][3].
Regarding potential contamination risks, the production and use of lactase enzyme involve several safeguards to minimize such risks. For instance, the GRAS notification for GODO-FAL includes strict adherence to current Good Manufacturing Practices (cGMP) to ensure the enzyme is produced and used safely. The risk of heavy metal contamination is mitigated through rigorous testing and quality control measures; for example, the enzyme must meet specific standards for heavy metal content to be considered safe for consumption. Similarly, the risk of pathogen contamination is managed through proper handling and processing procedures. While the use of pesticides in the cultivation of the microbial sources (e.g., _Aspergillus oryzae_) could be a concern, the final enzyme product is subject to purification steps that reduce such risks. Overall, the stringent regulatory and manufacturing standards help to ensure that lactase enzyme used in food and beverages is free from significant contamination risks, including heavy metals and pathogens[1][4].
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