Final Product Assay Services
Background Services FAQs Resources
Creative Biolabs is a leader in the pharmaceutical industry. We have a very powerful technical level and a wealth of experience in the production and quality control of drugs. We can provide excellent technical services in the final product assay of your Live Biotherapeutics Products (LBPs) development so that your project can be carried out smoothly.
Background
Quality is the first issue within the pharmaceutical industry. Drug quality refers to the standard or standardization under the provisions of the official Pharmacopoeia, without any errors. Quality control testing of both in-process and final products helps to ensure the overall quality of the product. For consumers, the quality of finished products is the most basic. Drugs must be safe first and are not at risk to the health of consumers.
Every batch of products, whether preclinical research or clinical research, needs to be tested to ensure that the active ingredients do not contain pollutants. All biopharmaceuticals entering the global pharmaceutical market need to carry out related testing on the final product packaging to prove that they meet the regulatory standards.
Final Product Quality Controls (FPQCs) Testing Services
FPQC are tests conducted after the completion of the manufacturing process. The purpose of FPQC is to check the qualitative and quantitative characteristics, test procedures, and acceptance limits, which must be followed by the final product within its effective shelf life.
1. Content Uniformity Testing
The USP content uniformity test is intended to ensure that the active ingredient is distributed uniformly among the individual units of a batch.
2. Content of Active Ingredients
An active ingredient is an ingredient in a pharmaceutical drug that is biologically active. For an LBP product, it refers to the number of living organisms per dose unit.
3. Friability Test
Friability testing is a laboratory technique used by the pharmaceutical industry to test the durability of tablets during transit.
4. Disintegration Test
Disintegration testing measures the ability of a tablet to break down into smaller particles or granules to allow the active drug to be absorbed into the body.
5. Dissolution Test
A dissolution experiment evaluates the rate and extent to which a product forms a solution under carefully controlled conditions.
6. Endotoxin Testing
Lipopolysaccharides (LPS) are bacterial endotoxins and are components of Gram-negative bacterial walls known to cause fevers and diseases. Endotoxin testing of biologicals manufactured in bacteria is a necessity to ensure that the therapeutic product is endotoxin-free.
7. Comparability & Lot Release Testing
Product release testing is a crucial part of ensuring drug product quality and safety. Lot Release and Comparability testing are necessary for evaluating the purity, potency, and identity of biologics.
Samples
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Probiotics
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Health products
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Supplements
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Biological products
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Raw food materials
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For other products please contact us to confirm.
If you are ready to submit your samples for testing, please fill out the Sample Submission Form.
Deliverables
Upon completion of the test services, a final report will be issued.
Frequently Asked Questions
What is batch release final product testing?
Batch Release final product testing refers to the process of ensuring that a batch of finished pharmaceutical or biological products meets quality standards and is safe for distribution. Batch-release testing applies to all batches of finished products manufactured at pharmaceutical or biotech facilities. In-process quality assurance (IPQA) ensures control samples and other relevant samples (stability, microbiology, validation) are collected.
What are the reference standards for batch release testing?
When it comes to batch release testing, several reference standards and guidelines are relevant:
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Good Manufacturing Practice (GMP) Guidance for Active Pharmaceutical Ingredients (APIs): This document provides comprehensive guidance on quality management, personnel qualifications, process equipment, documentation, materials management, production controls, packaging, storage, and laboratory controls.
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21 CFR 211.165: This section of the Code of Federal Regulations outlines requirements for the testing and release of pharmaceutical products for distribution in the United States. It emphasizes the need for thorough testing and compliance with specifications before releasing batches.
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USP Reference Standards: The United States Pharmacopeia (USP) offers pharmacopeial reference standards and documentary standards. These standards enhance certainty and confidence, reducing the risk of incorrect results and ensuring product quality.
What types of companies need to perform batch release testing?
Here are the types of companies that typically need to perform batch-release testing:
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Pharmaceutical Manufacturers
These companies produce finished pharmaceutical products, including tablets, capsules, injectables, and other dosage forms. They conduct batch-release testing to verify product quality and compliance with regulatory standards.
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Biopharmaceutical Companies
Biotech firms that manufacture biologics (such as probiotic raw material, monoclonal antibodies, biosimilars, and viral vectors) also perform batch-release testing. These complex products require rigorous safety checks before release.
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Contract Manufacturing Organizations (CMOs)
CMOs provide manufacturing services for other companies. They handle batch production and testing on behalf of pharmaceutical and biopharmaceutical clients.
Resources
If your product has been manufactured, you can contact us for the final product assay. Creative Biolabs will make your product better serve the research or market.
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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