Abstract

To successfully deliver probiotic benefits to the consumer, several criteria must be met. Here, we discuss the often-forgotten challenges in manufacturing the strains and incorporating them in consumer products that provide the required dose at the end of shelf life. For manufacturing, an intricate production process is required that ensures both high yield and stability and must also be able to meet requirements such as the absence of specific allergens, which precludes some obvious culture media ingredients. Reproducibility is important to ensure constant high performance and quality. To ensure this, quality control throughout the whole production process, from raw materials to the final product, is essential, as is the documentation of this quality control. Consumer product formulation requires extensive skill and experience. Traditionally, probiotic lactic acid bacteria and bifidobacteria have been incorporated in fermented dairy products, with limited shelf life and refrigerated storage. Currently, probiotics may be incorporated in dietary supplements and other “dry” food matrices which are expected to have up to 24 months of stability at ambient temperature and humidity. With the right choice of production process, product formulation, and strains, high-quality probiotics can be successfully included in a wide variety of delivery formats to suit consumer requirements.

Highlights

  • The most widely accepted definition of probiotics is the one proposed by a working group of the FAO/WHO in 2002 [1] and confirmed with minor grammatical changes by an ISAPP expert panel [2]: “Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host”

  • Special care is taken to understand the production conditions involved in manufacturing probiotics at a commercial scale and to evaluate the performance of strains under similar conditions at lab scale

  • Before end-product testing can occur and the results considered sufficiently reliable to be added to a certificate of analysis (COA), the quality control (QC) lab needs to have implemented several programs which help to ensure the quality of the product

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Summary

Introduction

The most widely accepted definition of probiotics is the one proposed by a working group of the FAO/WHO in 2002 [1] and confirmed with minor grammatical changes by an ISAPP expert panel [2]: “Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host”. This definition implies five important things (Table 1). This benefit should be shown in the target host population

Manufacturing Probiotics and Dairy Starter Cultures
Development of Strain Production
Strain Nutritional Requirements
Manufacturing Raw Materials
Process Control and Consistency
Species and Strain Dependencies
Raw Materials for Growth Media with Special Requirements
Evolution of Quality Control
21 CFR 111
10. Inclusion of Probiotics in Dietary Supplements
11. Inclusion of Probiotics in Foods and Beverages
11.1. Fermented Milk Products
11.2. Ice Cream
11.3. Probiotic Cheese
11.4. Other Dairy Applications
12. Inclusion of Probiotics in “Medical Devices”
13. Conclusions
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