YOUR TRUSTED

BACTERIOPHAGE MANUFACTURING

PARTNER

We specialize in both GMP and non-GMP bacteriophage production (from discovery and preclinical development to clinical trials and commercial production). We provide the entire lifecycle of bacteriophage development, offering comprehensive solutions from process development to optimization.

PARTNER WITH US

PARTNERSHIP ALREADY AT R&D LEVEL

PRODUCTION OF PRE- CLINICAL MATERIAL

OPTIMIZATION OF MANUFACTURING PROCESS

FORMULATION STUDIES

PRODUCTION OF GMP MATERIAL

FULL ANALYTICAL TESTING

VARIOUS STABILITY PROGRAMS

PREPARATION OF CMC DOCUMENTATION

phage process

We optimize the entire production lifecycle—from petri dish to bioreactor—ensuring high phage titers, yields and purity with cost-effective and cutting-edge processes.

PHAGE DISCOVERY

Phage hunt:

-Selection & analysis of relevant target bacteria strains

-Evaluation of strains compared to global panel

-Testing target (clinical) strains against JAFRAL phage bank and environmental samples

Phage isolation:

-Selection of specific phages based on efficacy, paired with an optimal production host.

Characterization of phages & production hosts:

-Genome sequencing

-Bioinformatics analysis

-Preparation of a Phage Certificate/Passport

CELL BANKING

Phage banks:

Research Phage Seed (RPS)

Master Phage Seed (MPS)

Working Phage Seed (WPS)

BACTERIAL BANKS:

Research Cell Bank (RCB)

Master Cell Banks (MCB)

Working Cell Bank (WCB)

We have experience working with a wide range of bacteria as hosts for phage production, including:
‍

Staphylococcus spp.

Pseudomonas spp.

Enterococcus spp.

Klebsiella spp.

Acinetobacter spp.

Enterobacter spp.

Escherichia spp.

Mycobacterium spp and many more...

PROCESS DEVELOPMENT (UPSTREAM & DOWNSTREAM)

Parameters:

-Growth media

-Biomas

-Inoculation density

-Dissolved oxygen

-Temperature

-Culture time

-Filtration

-Experiments done using Design of Experiment (DOE)

Phage amplification:

-Small scale fermentation

-Large scale fermentation

Clarification

Phage purification:

-Ion-exchange chromatography

-Gel filtration

-Diafiltration

-Affinity chromatography

Final filtration

DEVELOPMENT AND QUALIFICATION / VALIDATION OF ANALYTICAL METHODS

Preparation of positive controls & reference standards

Selecting and optimizing analytical methods

-Establishment of performance characteristics

Qualification / Validation of methods

Sample analysis

FORMULATION

Evaluation of appropriate excipents for specific application / indication.

Performing formulation studies based on Desing of Experiment (DOE).

Types of formulations:

-Liquid

-Serum

-Lyophilization

-Encapsulation

-Spray - dying

-Gels

PRODUCTION OF LARGE SCALE/NON-GMP/GMP/CLINICAL TRIAL MATERIAL

Preparation oF Batch Records

Batch execution

In-Process-Control (IPC) testing

Final release testing

FILL & FINISH

Media Fill / Aseptic Process Simulation

Sterile / Non-sterile filling

Container Closure Integrity testing

Labelling

Visual inspection

YOUR TRUSTED

BACTERIOPHAGE MANUFACTURING

PARTNER

PARTNERSHIP ALREADY AT R&D LEVEL

PRODUCTION OF PRE- CLINICAL MATERIAL

OPTIMIZATION OF MANUFACTURING PROCESS

FORMULATION STUDIES

PRODUCTION OF GMP MATERIAL

FULL ANALYTICAL TESTING

VARIOUS STABILITY PROGRAMS

PREPARATION OF CMC DOCUMENTATION

phage process

PHAGE DISCOVERY

CELL BANKING

PROCESS DEVELOPMENT (UPSTREAM & DOWNSTREAM)

DEVELOPMENT AND QUALIFICATION / VALIDATION OF ANALYTICAL METHODS

FORMULATION

PRODUCTION OF LARGE SCALE/NON-GMP/GMP/CLINICAL TRIAL MATERIAL

FILL & FINISH

therapeuthic areas

HUMAN THERAPEUTICS

HUMAN THERAPEUTICS

VETERINARY

VETERINARY

FOOD SUPPLEMENTS

FOOD SUPPLEMENTS

AGRICULTURE

AGRICULTURE

DERMATOLOGY

DERMATOLOGY

You might be interested

FILL & FINISH

BIOLOGICALS

RESOURCES

cONTACT
OUR EXPERT

YOUR TRUSTED

BACTERIOPHAGE MANUFACTURING

PARTNER

PARTNERSHIP ALREADY AT R&D LEVEL

PRODUCTION OF PRE- CLINICAL MATERIAL

OPTIMIZATION OF MANUFACTURING PROCESS

FORMULATION STUDIES

PRODUCTION OF GMP MATERIAL

FULL ANALYTICAL TESTING

VARIOUS STABILITY PROGRAMS

PREPARATION OF CMC DOCUMENTATION

phage process

PHAGE DISCOVERY

CELL BANKING

PROCESS DEVELOPMENT (UPSTREAM & DOWNSTREAM)

DEVELOPMENT AND QUALIFICATION / VALIDATION OF ANALYTICAL METHODS

FORMULATION

PRODUCTION OF LARGE SCALE/NON-GMP/GMP/CLINICAL TRIAL MATERIAL

FILL & FINISH

therapeuthic areas

HUMAN THERAPEUTICS

HUMAN THERAPEUTICS

VETERINARY

VETERINARY

FOOD SUPPLEMENTS

FOOD SUPPLEMENTS

AGRICULTURE

AGRICULTURE

DERMATOLOGY

DERMATOLOGY

You might be interested

FILL & FINISH

BIOLOGICALS

RESOURCES

cONTACTOUR EXPERT

PRODUCTION OF PRE- CLINICAL MATERIAL

PREPARATION OF CMC DOCUMENTATION

cONTACT
OUR EXPERT