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Quality Controls

Creative Biolabs has leading technology in the field of phage and phage lysin manufacturing. We design and validate the manufacturing processes in accordance with quality manufacturing specifications and analytical methods to ensure the safety and stability of phage and phage lysin biological products.

Identity Analytical Assay

Although the manufacturing processes have been designed and optimized, random mutations in the reproduction process are inevitable. Therefore, sequencing of phage is an essential approach to confirm its identity. PCR-based assays, next generation sequencing (NGS), and metagenomics are currently available to identify phages. In addition, the identity of the host systems can also be identified by these methods.

Purity Analytical Assay

Generally, the purity and composition of biopharmaceuticals, such as phage capsid proteins, phage lysins, toxins, and other bacterial proteins, are determined via the combination of high performance liquid chromatography and mass spectrometry.

Titer Analytical Assay

Phage titer analysis is a procedure to quantify the density of plaque-forming units in each lysate. The phage samples are diluted and plated with susceptible cells. The bacteriophage acts its lytic properties to form a circular plaque of reduced turbidity. The double agar layer (DAL) assay determines the number of viable phage particles in a stock suspension. In addition, the titer of phage can be determined via time-kill assay, qPCR, and ELISA.

Protein Concentration Determination Assay

The determination of the number of phage lysins in a solution can be achieved by direct measurement of absorbance using UV-vis, which is a rapid assay, with generally low accuracy or sensitivity. Highly accurate quantification of phage lysins can be measured using the Bradford assay or the bicinchoninic acid (BCA) assay. The Bradford assay is a colorimetric assay dependent on the binding of protein to Coomassie Brilliant Blue. The BCA assay is also a colorimetric assay leveraging the reduction of Cu2+ by phage lysins and the combination of BCA. The phage lysin concentration is then determined by reference to a standard curve.

Contaminant Analytical Assay

Endotoxins are analyzed via gel-clot assay, turbidimetric assay, and chromogenic assays such as the Limulus amebocyte lysate (LAL) assay. Microbial contaminations include microbiome and microbial toxic proteins, such as enterotoxins. The analytical assays detecting microbial toxic proteins can use ELISA, while residual nucleic acids can be detected by qPCR. Reporter cell line-based assays can be utilized to detect toxic contaminations and nucleic acid contaminations.

Stability Analytical Assay

Our stability studies include stability, lytic activity, and property determinations of drug products of phage or phage lysin under various influencing factors (e.g., temperature, humidity, light, repeated freezing and thawing, vibration, oxidation, pH, and other relevant conditions).

Quality Controls

Creative Biolabs is a leading global contract development and manufacturing company offering a full range of phage and phage lysin manufacturing technologies and analytic services. We also provide customized detection services and solutions to optimize analytic processes for our global customers. To learn more about quality controls, please feel free to contact us.

For Research Use Only. Do NOT use in humans.

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* For Research Use Only. We do not provide direct services or products for patients.