Final Product Assay Services

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.

Introduction

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)

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.

FPQC Testing Services at Creative Biolabs

• Uniformity of Content

The USP content uniformity test is intended to ensure that the active ingredient is distributed uniformly among the individual units of a batch.

• 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.

Fig.1 1P limits for content of active ingredients. (Uddin, 2016)

• Friability Test

Friability testing is a laboratory technique used by the pharmaceutical industry to test the durability of tablets during transit.

• 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.

• Dissolution Test

A dissolution experiment evaluates the rate and extent that a product forms a solution under carefully controlled conditions.

• 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.

• 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.

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.

Reference

1. Uddin, M.S.; et al. In-process and finished products quality control tests for pharmaceutical capsules according to pharmacopoeias. Journal of Pharmaceutical Research International. 2016: 1-9.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.