Production and Purification of Phage

As a leading specialist in the development of phage for therapy, Creative Biolabs excels at the production and purification of diverse phages, including reporter phage, labeled phage and therapeutic phage. Our custom manufacturing program consists of laboratory synthesis and rapid scale-up. We offer custom production and purification service according to our clients' needs in a timely manner.

Demands of Large-scale Production of Phages

Antibiotic-resistant bacteria are observed with increasing prevalence. Alternatives to antibiotics have thus become a public health priority for the treatment of bacterial infections. There has been a resurgence in the use of bacteriophages as therapeutics. Applications of phages include antibiotic replacement, gene therapy vectors, vaccines, diagnostics using filamentous phages and novel optical applications such as the phage laser. This has increased demand for investigations into large-scale production of bacteriophage. However, the large-scale production of wild type or genetically modified bacteriophages for use in the biotherapeutics industry provides significant process and regulatory challenges. Moreover, many of the techniques that are used at small scales are not transferable to large-scale production facilities of phage in industrial processes.

Phage Production at Creative Biolabs

Generally, fermentation process parameters are mainly optimized to improve the phage titer and to increase the phage/impurity. Bacterial and phage inocula, type of nutrients, agitation, oxygenation, pH, temperature strongly influence the phage titer. With extensive experience in phage production, we offer feasible production systems (laboratory synthesis and rapid scale-up) of phages under the international guidelines of Good Manufacturing Practice (GMP). Our commonly used production systems include fermenters (25 L to 200 L) and wave bag disposable systems.

Phage Purification at Creative Biolabs

Some phages degrade the DNA of the host, however, not consistently to a safe level. Proteases should be removed as they could negatively influence the shelf life of phages. The purification process is designed to consistently achieve the specifications of target phages, our featured purification strategies including:

• PEG precipitation
• CsCl gradient centrifugation
• Purification using ultrafiltration
• Purification using centrifugation (ultracentrifugation and prolonged medium-speed centrifugation)
• Purification using chromatography

Highlights:

• Production of phages under GMP
• Short duration, reduced risk of genetic instability and feasible scale-up
• Scale-up appears feasible
• Phage growth to high titers
• Strict quality controls
• Avoid phage cross-contamination
• Highest amounts of bacteriophages in a single fermentation

After bacteriophage production and purification, the typical quality controls include phage identification by mass spectrometry (MS), absence of contaminating phages, titer determination by double agar layer method (DAL), time-kill assays, qPCR or ELISA, the maximum level of bacterial toxins and other contaminants, pH, sterility, and shelf life.

You can get access to more detailed information about our phage production and purification services through the following links.

• Manufacturing of Phage
• Manufacturing of Phage Lysin
• Quality Controls
• Formulation Development

Powered by our advanced platforms and Ph.D. level scientists, Creative Biolabs has accumulated extensive experience in offering custom production and purification of phages. For more detailed information, please contact us for more information and a detailed quote.