MICROBIOTIX

MicrobiotiX strives to develop treatments
 for global intractable diseases
such as multidrug-resistant
bacterial infections, autoimmune diseases and cancer

GMP

Phage, Microbiome
& Beyond

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.

CMC
Optimization

Phage characterization
& Process optimization

GMP
Documentation

QbD-based drug
substance development

Establishment of
bacteriophage experts


Bacteriophage Production Process

01

Bacteriophage
library

02

Phage culturing
after seed culturing

03

Phage concentration
after filtration

04

AKTA purification
(removal of endotoxin)

05

Drug substance put
to refrigerated storage

06

Manufacturing drug product
(labeling, box packaging)

07

Automatic
vial filling


GMP

GMP

Incubation Room


30L (Fermenter) incubator
automatic sterilization system
(SIP) applied


GMP

Refinery


AKTA Pure (Refining equipment) 

Sartoflow (TFF equipment) 


GMP

Charging Room


Automatic vial filling machine

Production CAPA: 200,000 vials per month (1 vial = 10ml)

Grade A (chamber) management


GMP

Quality Control Laboratory


Endotoxin testing equipment 

Real time PCR

TOC testing equipment 



MICROBIOTIX

Quality Assurance

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 SystemAll 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.
Materials System
Production System
Packaging & Labeling System
Facilities & Equipment System
Laboratory Control System

Document SystemIntroduction of the document management system.
MicrobiotiX operates a document management system for the controlled creation, approval, and storage of all cGMP-related documents.
01
Governance

02
Policy

03
Directive

04
Standard Operating Procedure

05

Forms and

Worksheets


MICROBIOTIX

Quality Control

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.

Risk
assessment
analysis

Production Process

Education
and document
completion

Validation
Correction

Monitoring

Deviation
management

Product
quality
evaluation

Trend analysis

Improvement

Immediate improvement
measures to prevent recurrence


Quality Management Testing CapabilitiesThroughout 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

MICROBIOTIX CO., LTD

Severance Hospital Clinical Research Center #221   l   TEL : 02. 6379. 2649   l   E-mail : mx@microbiotix.net

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