QC Analytical Testing for Live Biotherapeutic Products

As a leading international biopharmaceutical company, Creative Biolabs has powerful specialized knowledge, an advanced technology platform, 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 customed analysis solutions, making your product stand out.

QC analytical procedures are essential for demonstrating that a drug product is suitable for a specific purpose. Common validation characteristics in live biotherapeutic products (LBPs) are as follows:

Moisture Analysis

Moisture analysis includes various methods for measuring moisture content in both high level and trace amounts in solids, liquids, or gases. 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 products.

Colony Morphology

LBPs contain live organisms, such as bacteria, thus the examination of colony morphology is the first step in the identification of LBPs. In microbiology, colony morphology refers to the visual appearance of bacterial or fungal colonies on an agar plate. Different kinds of bacteria produce different colonies. The systematic assessment of the colony morphology provides clues to the identity of organisms, which includes:

  • Culture conditions
  • Color
  • Margin
  • Opacity
  • Form
  • Elevation
  • Surface
  • ther (odor, staining, et al.)

Colony morphology of a capsulated bacterium. Fig.1 Colony morphology of a capsulated bacterium. (Kandi, 2015)

Cell Morphology

Bacteria can be classified by the light microscope according to their morphology and arrangement. The basic morphologies are spheres (coccus), round-ended cylinders (bacillus), helically twisted cylinders (spirochetes), cylinders curved in one plane (selenomonads), and unusual morphologies (such as the square, flat box-shaped cells of the archaean genus Haloquadratum). The arrangements include pairs, tetrads, clusters, chains, and palisades.

Appearance

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.

Microbial Limits Testing (MLT)

MLT is used to determine whether a non-sterile pharmaceutical product conforms to established microbial quality specifications. This is an important set of tests designed to limit the possibility of any adverse event resulting from the presence of high levels of microorganisms in non-sterile products. By limiting the number of bacteria present in the product under test, the likelihood of this happening is automatically reduced. These sections include microbial enumeration test and specified microorganisms test. For non-sterile products, we can test for microbial contamination using a unified pharmacopoeial or client-supplied method to determine the bioburden within the sample. Available services are as follows:

  • MLT Method Suitability Test
  • Microbial Enumeration (Total Aerobic Microbial Count and Total Combined Yeasts and Mold Count)
  • Specified Microorganisms Test

Bioburden Determination

Bioburden refers to the number of microorganisms living on an unsterilized surface. The purpose of bioburden testing (microbial limit testing) is to determine the total number of viable microorganisms (total microbial count) before sterilization. Products used in the pharmaceutical or medical field require to control of the microbial levels during processing and handling.

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.

Reference

  1. Kandi, V. Bacterial capsule, colony morphology, functions, and its relation to virulence and diagnosis. Annals of Tropical Medicine and Public Health. 2015, 8(4): 151.

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