MicrobiotiX strives to develop treatments
for global intractable diseases such as multidrug-resistant
bacterial infections, autoimmune diseases and cancer
Global Top 10 Bacteriophage Production
with Optimized CMC Controls (QbD process applied)
The GMP plant is responsible for the mass production of medicine to be used in clinical trials (phage treatments) currently under research and development. It aims to produce high-purity medicine through strict compliance and thorough quality control.
GMPGood Manufacturing Practice
GMP embodies various conditions for manufacturing high-quality medicine and is a norm that should be observed throughout the quality management process, from the arrival of raw materials to the shipment of the final product. The purpose of modernization is to manufacture high quality medicine with a high stability by eliminating errors that may occur in the pharmaceutical manufacturing process and by minimizing contamination through automated manufacturing facilities and strict process management.
Bacteriophage Production Process
Drug substance put
Manufacturing drug product
30L (Fermenter) incubator
AKTA Pure (Refining equipment)
Sartoflow (TFF equipment)
Automatic vial filling machine
Production CAPA: 200,000 vials per month (1 vial = 10ml)
Grade A (chamber) management
Quality Control Laboratory
Endotoxin testing equipment
Real time PCR
TOC testing equipment
The quality department of MicrobiotiX operates independently from the production department, the quality department is responsible for ensuring that all cGMP processes meet the regulatory agency’s guidelines and requirements.
|Quality System||All cGMP processes are followed to adhere to all regulatory guidelines and requirements. The quality department at MicrobiotiX ensures that all systems and equipment are maintained during the cGMP production period through the quality system in place to produce high quality products.|
|Packaging & Labeling System|
|Facilities & Equipment System|
|Laboratory Control System|
|Document System||Introduction of the document management system.|
MicrobiotiX operates a document management system for the controlled creation, approval, and storage of all cGMP-related documents.
Standard Operating Procedure
MicrobiotiX adheres to a strict quality control policies that meet global GMP regulations. We focus on delivering the highest quality products and services to our customers. This starts with ensuring high quality processes and facility operations are maintained. Our company policies are to have personal responsibility to maintain regulatory standards, promote a culture of quality compliance, and maintain world-class quality. Our leadership supports, recognizes, and rewards quality excellence. MicrobiotiX conducts risk assessments that can affect our product’s quality, stability, and/or efficacy by applying the ICH Q9 Quality Risk Management and ICH Q10 Pharmaceutical Quality System to the scientific information and data accumulated during development.
|Quality Management Testing Capabilities||Throughout the production process, the quality control team conducts quality tests on all samples, including raw materials, in-process, DS/DP, and stability tests. In addition, the customer has the ability to transfer testing methods and perform testing method verification in accordance with the FDA, EMA, and PMDA requirements along with the ICH Q2(R1) guidelines. MicrobiotiX maintains an optimal working environment for producing high-quality products by routinely testing facility-related samples such as environment monitoring, water and steam quality, and clean gas systems. All tests are conducted in accordance with strict cGMP requirements. Environmental testing includes testing for viable/non-viable air particles and surfaces, as wells as clean utility monitoring, including bioburden, endotoxin, TOC(organic carbon), conductivity, nitrate, properties and pH of water, and compressed air and steam testing.|
1. Polymerase Chain Reaction (PCR)
2. Enzyme Immunoassay (ELISA)
3. Electrophoresis (Gel, Capillary)
1. Aseptic testing
2. Microbial limit testing (Bioburden)
3. Endotoxin testing