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Manufacturing of Phage

Creative Biolabs has advanced technology and a team of professional scientists with extensive experience in the phage field. We provide not only phage-based therapy development services, but also phage production services from small scale to large scale. With our world-leading manufacturing technology, our custom development and manufacturing services will accelerate the progress of phage-related breakthrough investigations.

Phage Identity Confirmation

Identity confirmation of active ingredient phage via sequencing and transduction tests is imperative to exclude lysogeny, antimicrobial resistance, and virulence factors. Our quality control services can assist you in conducting comprehensive phage characterization to avoid any contaminants. After phage identity is confirmed, isolation and enrichment of the phage will be performed.

Production Strain Identity Confirmation

In conjunction with our phage engineering services, we offer genetic modification of bacterial hosts to produce high titer, low endotoxicity phage products, which ease the purification process. The identification of host bacterial strains used for phage production with our quality control services is of vital importance, as they directly influence the quality and purity of phage products.

Fermentation

Creative Biolabs is equipped with advanced industrial-scale fermentation bioreactors. Our fermentation process can be optimized for different phage and bacterial hosts by adjusting various parameters of the fermentation process, including pH, temperature, nutrient types, agitation/oxygenation, etc., to produce high titer, high purity, low endotoxicity phages. We offer you a semi-batch model of fermentation to ensure continuous large-scale production while avoiding co-evolution of phages and production strains.

Phage Purification

Many impurities are still present in the products obtained after phage fermentation. For phages used as drug products, the removal of impurities is one of the most important steps. For phage-based therapies, endotoxins of phages and bacterial toxins, such as enterotoxins and alpha toxins, have a great impact on the safety of drug products. The residual microbial DNA and microbial compounds and phage double-stranded RNA (dsRNA) in phage products are significant contributors to inflammation. In addition, proteases have a negative impact on the stability and preservation of phage products.

To remove endotoxin and other residual contaminants, we use the following phage purification processes depending on different phages:

  • Sterile filtration
  • Pre-treated with enzymes
  • PEG precipitation
  • CsCl gradient centrifugation
  • Ultrafiltration
  • Centrifugation (ultracentrifugation and prolonged medium-speed centrifugation)
  • Ion-exchange chromatography
  • Affinity chromatography
  • Solvent extraction

Stabilization and Formulations

Phages have been widely used as therapeutic agents in human and animal health, agriculture, and food industries, etc., typically in liquid phage products, as well as in oral solutions, inhalants, patches, etc. To avoid aggregation, adsorption, chemical degradation, or oxidation of phage particles that can affect the efficacy of phage-based therapy, you can use our liquid formulation, lyophilization, encapsulation, emulsification, or microencapsulation services to solve the phage formulation problems. To ensure the final stability of the formulation, we will design and determine the correct balance of adjuvants with APIs for your phage therapies and evaluate the stability and safety of the final drug product.

Manufacturing of Phage Cocktail

We also offer the manufacturing service of phage cocktails on top of the manufacturing of monophage-based therapy. We provide you customized phage cocktail manufacturing services, including designing, producing, analyzing, and confirming all phages contained in the phage cocktail. Our stabilization and formulation services guarantee the correct balance of adjuvants with various phages as well as the stability and safety of the final phage cocktail products.

Manufacturing of Phage

Creative Biolabs is the world's leading contract development and manufacturing company, providing you with a comprehensive range of phage manufacturing technologies and related services. Our manufacturing facilities are designed to meet any of your requirements from laboratory-scale to industrial-scale manufacturing. We also offer our global customers solutions for the design of phage manufacturing and the optimization of phage manufacturing processes. If you would like to learn more about the manufacturing of phages, please do not hesitate to contact us.

To learn more details, you can also get access with the following links:

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.