QC Analytical Testing for Live Biotherapeutic Products
Overview Services FAQ's
As a leading international biopharmaceutical company, Creative Biolabs has powerful specialized knowledge, an advanced technology platform, and rich R&D experience. Our QC analytical testing laboratories are equipped with state-of-the-art analytical equipment and testing facilities. We will work with you to develop custom analysis solutions, making your product stand out.
Overview
Recently obtained information on the role of the microbiota in human function makes it possible to envisage an increasing use of probiotics. Probiotics are live microorganisms, and the high strain specificity of most of its benefits, so the product quality is the key. According to the two standards, the product is considered to be acceptable: (1) the quantity of bacteria announced is exact, and (2) the strains announced are present in the product. The most important characteristics of probiotic products are the viability mentioned on the label and the accurate bacterial content. Quantitative is based on each tested bacterial species bacteria/strain results for the cultivation of the selective medium. Although there are many challenges plate count method, the colony forming unit (CFU) quantitative probiotic products in living cell count is still the gold standard method.
QC Analytical Testing Services
Fig.1 Workflow of plate count method.
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Method
Plate count method
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Types of Probiotic Sample
Live biotherapeutic products, food, feed, health care products, dietary supplements, microbial agents (fertilizer).
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Detectable Probiotics
Bifidobacterium spp., Lactobacillus spp., Bacillus spp., Saccharomyces spp., Streptococcus thermophilus, next-generation probiotics, et.al.
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Testing Standards
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Internal methods
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ISO standard or similar
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Client-provided methods
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Applications
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Confirm label claims through species verification.
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Determine the CFUs present in the finished product.
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To monitor the survival of probiotics over the expected shelf life of the product.
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Method validation and troubleshooting services.
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Absence of Specified Organisms
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Testing Standards
USP <62> or similar
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Testing Standards
USP <232/233> or similar
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Testing Standards
USP <791> or similar
Appearance testing is probably the most subjective but important test performed on drug substances, which can provide information regarding the solid-state of the product. Colour can be used as an indicator of purity and to identify contamination that occurs during the synthesis process.
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Testing Standards
USP <922> or similar
In commercial pharmaceutical production, moisture is monitored as a percentage. In many applications, trace moisture measurement is necessary for manufacturing and process quality assurance. Which must be controlled in drug product.
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Microbiological Contaminant Testing
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Organisms that can be detected are:
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Aerobic Plate Count
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Non-Lactic count
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Coliforms
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Yeast and Mold
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Salmonella
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Pseudomonas aeruginosa
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Candida albicans
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Burkholderia cepacia
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Testing Standards
USP <61>, USP <62>, USP <60>, ISO 13559 or similar
QC Analytical Testing performed by Creative Biolabs ensures that your LBPs meet the relevant standards. Creative Biolabs provides quality assessment for your production process and can work with you to provide solutions and improvements. If you need, please contact us for more specific services.
Frequently Asked Questions
Q. What are the criteria by which a probiotic product is considered acceptable?
A. According to two criteria, the product is considered acceptable: the disclosed bacterial count is accurate and the disclosed strain exists in the product.
Q. What aspects of probiotic preparations on the market are likely to be of concern to consumers and relevant regulatory authorities?
A. Attention may include:
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Does the product contain as many bacteria as stated on the product label?
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Does the product contain bacteria of the same type and/or strain as described on the packaging?
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Has the number of bacteria indicated on the product label remained unchanged from production, storage to consumption?
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Does the product truly provide health benefits as claimed by the manufacturer?
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Has any independent laboratory tested the bacterial content and claimed benefits of these probiotic products?
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Does the product contain microorganisms that are not listed on the production trademark label?
Q. What are the main methods for enumeration of bacteria?
A. The most robust counting technique becomes crucial for accurately quantifying the microbial load of a given probiotic formulation. The main methods for bacterial counting include plate counting, microscopic counting, electron particle counter, and flow cytometry. The plate counting method is the most commonly used method for determining the bacterial count in a specific sample. It is worth noting that live probiotics may exist in a live but uncultivated (VNC) state. Cell culture techniques can only estimate the number of replicates, but cannot estimate the number of strains in the VNC state.
For Research Use Only. Not intended for use in
food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.
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