Microbial Control

Bacteriophages currently present a novel paradigm to resolve a wide variety of biological problems. Interest in phage-based therapies and technologies has skyrocketed in recent years, and Paragon Bioservices is poised to deliver a diverse and extensive portfolio of contract phage service offerings including:

Paragon provides contract services that include the development and manufacturing of safe, natural , bacteriophage-based antibacterial solutions for: Food Safety, Animal Health, Biodefense, Human Therapeutics and Hospital and Industrial Sanitation.

Bacteriophages are viruses that infect only bacteria—and destroy them in the process. The fact that these amazing organisms are capable of overcoming bacterial resistance is a major advantage over conventional antibiotics:

Phages are effective against multi-drug resistant bacterial strains

Targeted phages have a minimal impact on commensal microflora

Phages are less likely to create dybiosis or disseminate resistance

Paragon’s team can isolate phages from any number of sources—such as plant effluents, animal carcasses, processing surfaces and environmental samples.

Our client base and target markets for these services include agencies of the Federal Government, biotechnology companies, pharmaceutical companies and global consumer product companies.

Bacteriophage Research & Discovery Services

Specific tasks include evaluating bacterial field strains, assembling and maintaining a panel of bacterial field isolates, identifying suitable strains for phage isolation and production, screening environmental samples for phages with desired activity, evaluating phages for host range and other characteristics, maintaining phage and bacteria libraries, and supporting products post launch. In addition to the tasks described above, Paragon will also develop the necessary high‐throughput analytical methods to facilitate the timely characterization of bacterial and phage samples supplied. All work done, including all raw data, will be detailed and supplied to the client in the form of a final report.

Analytical Method Development

Evaluation of Field Strains of Bacteria

Assembly and Maintenance of Field Isolate Panel

Identification of Suitable Strains for Phage Isolation and Production

Screening Phages for Desired Activity

Assembly and Maintenance of Phage Library

Bacteriophage Process Development

Paragon will first develop a small scale manufacturing process in shake flasks, optimizing media and infection parameters. Once developed, Paragon will then prepare new research cell banks of the production strains and seed banks for each of the bacteriophage strains. Utilizing the new research cell banks, Paragon will proceed to implement and adapt the small scale manufacturing process to pilot scale (i.e. fully‐controlled 15L and 100L fermentors). The process will be evaluated and optimized as necessary. Paragon will also evaluate and attempt to optimize client supplied test methods, establish specifications of the individual bacteriophage strains, and evaluate the stability of individual strains. Material generated at both the 15L and 100L scale can be supplied, at the client’s request, for their internal use. All work done, including all raw data, will be detailed and supplied to the client in the form of a final report, to be submitted for review at the completion of the project.

Generation of Research Microbial Cell Banks & Bacteriophage Stocks

Evaluation and Optimization of Pilot Scale Process (Up to 15L)

Bank Cryopreservation and Stability Study

Stability Study of Final Bulk Product

Bacteriophage Manufacturing

Individual bacteriophages material will be blended to reach the desired specifications of the final product (as specified by client). Final material will be sterile-filled in labeled PETG containers (or as specified by the client) and stored at 4˚C, pending shipment. The pilot manufacturing run will be executed utilizing our drafted SOP’s and manufacturing documents.

GMP and Non-GMP Manufacturing Capacity

Multi-Phage Cocktail Formulations

Segregated Production Suites—completely segregated from all other GMP manufacturing

Quality Release of Manufactured Lots

Typical Deliverables

Final report detailing the methods and all results from the evaluation, optimization and qualification experiments

Remaining cryovials from the research cell and viral banks

All SOP documents created for this process

All manufacturing documents created and used for this process

All fermentation batch records

Entire yield of purified bacteriophages

 

More About Bacteriophages

Clients with projects that target antibiotic-resistant bacteria or food-borne bacteria come to Paragon for process development and large-scale manufacturing of bacteriophages.

According to the Center for Disease Control (CDC), it is estimated that, annually, 76 million people become ill, another 300,000 are hospitalized and more than 5,000 die from eating food contaminated with a food-borne pathogen such as E.coli, Listeria and Salmonella.

Bacteriophage solutions are currently being used to eliminate contamination from the food and water supply. Their use in pharmaceutical initiatives provides relief from bacterial infections and helps solve a variety of human problems without the adverse affects of some traditional antibiotics. They also have multiple applications and advantages for pathogen control in the agricultural, industrial and biodefense sectors as well.

Since 2000, Paragon Bioservices has been helping clients with the process development and large-scale production and purification of bacteriophages. We help scientists develop safe, natural bacteriophage solutions for food safety, animal health and veterinary applications, human therapeutics (infectious diseases), biodefense, industrial applications (food and meat processing plants, hospital sanitation, etc.)

All bacteriophage work is performed at Paragon’s facility at the University of Maryland BioPark—and is segregated from all other research and manufacturing operations.

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