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.We aim to manufacture high-quality pharmaceuticals with high stability by eliminating human errors that may occur in the pharmaceutical manufacturing process, along with minimizing contamination through automated manufacturing facilities and strict process control.
CMC
Optimization
QbD based Bacteriophage |
Process optimization Drug substance development GMP documentation |
Bacteriophage production Establishment of professional manpower |
Bacteriophage Production Process
 | 01 Bacteriophage |
 | 02 Phage culturing |
 | 03 Phage concentration |
 | 04 Removal |
 | 05 Drug substance put |
 | 06 Automatic |
 | 07 Manufacturing drug product |
GMP
GMP Incubation Room 30L (Fermenter) incubator |  |  |
GMP Refinery TFF membrane (phage concentration) |  |  |
GMP Charging Room Grade A(within the automatic vial filling machine) Production Management |  |  |
GMP Quality Control Laboratory Microplate reader (Endotoxin) |  |  |
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we have a lot of fun during this phase.We are working on an exciting project for a company in the investment business. Stay tuned!
We design and build digital products people enjoy using...
Hey! Recently we were working on a project for ..We design and build digital products people enjoy using...
We are a Creative Digital Agency based in Buenos Aires, Argentina. We take pride in designing and building...
A new project is an opportunity to create something unique.We are a Creative Digital Agency based in Buenos Aires, Argentina. We take pride in designing and building...
As an interdisciplinary agile team, our production process is flexible, collaborative, and adapts to each client’s needs
We look forward to working with you on your next projectAs an interdisciplinary agile team, our production process is flexible, collaborative, and adapts to each client’s needs
We are working on the UX/UI design for a large hotel owners and hospitality management company.
Style Tiles are always a good option to show work in progress!We are working on the UX/UI design for a large hotel owners and hospitality management company.
More shots with final designs coming soon.
You can check the attachment for a full view..More shots with final designs coming soon.
we streamline the process without having to make multiple mockups.
This is a proposal to add value to a crowdfunding listing pagewe streamline the process without having to make multiple mockups.
Style tiles serve as a flexible starting point that helps us easily communicate the essence of a visual brand for the web.
Clients easily understand themStyle tiles serve as a flexible starting point that helps us easily communicate the essence of a visual brand for the web.
We are working on an exciting project for a company in the investment business. Stay tuned!
we have a lot of fun during this phase.We are working on an exciting project for a company in the investment business. Stay tuned!
We design and build digital products people enjoy using...
Hey! Recently we were working on a project for ..We design and build digital products people enjoy using...
We are a Creative Digital Agency based in Buenos Aires, Argentina. We take pride in designing and building...
A new project is an opportunity to create something unique.We are a Creative Digital Agency based in Buenos Aires, Argentina. We take pride in designing and building...
As an interdisciplinary agile team, our production process is flexible, collaborative, and adapts to each client’s needs
We look forward to working with you on your next projectAs an interdisciplinary agile team, our production process is flexible, collaborative, and adapts to each client’s needs
We are working on the UX/UI design for a large hotel owners and hospitality management company.
Style Tiles are always a good option to show work in progress!We are working on the UX/UI design for a large hotel owners and hospitality management company.
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 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. |
| Materials System |
| Production System |
| 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. |
| 01 Governance |
| 02 Policy |
| 03 Directive |
04 Forms and Worksheets |
| 05 Standard Operating Procedure |
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 Equipment |
 |
Education Managing & determining the level of equipment |
 |
Monitoring Deviation |
 |
Product Quality standards |
 |
Improvement Immediate measures to prevent issues Quality improvement Increase productivity |
| 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. In addition various tests are routinely conducted to maintain an optimal working environment for producing products. For example, environmental monitoring, testing of the purified water for injection are conducted to sustain the optimal working environment |
1. Real time PCR (DNA dose) |
1. Sterility Test |
MICROBIOTIX CO., LTD
IT Mirae Tower, 33, Digital-ro 9-gil, Geumcheon-gu, Seoul (60-21 Gasan-Dong, #304)
TEL : 02. 6379. 2649
E-mail : mx@microbiotix.net
Copyright © MICROBIOTIX. All rights reserved.
INQUIRIES |
MICROBIOTIX CO., LTD
IT Mirae Tower, 33, Digital-ro 9-gil, Geumcheon-gu, Seoul (60-21 Gasan-Dong, #304)
TEL : 02. 6379. 2649 l E-mail : mx@microbiotix.net
Copyright © MICROBIOTIX. All rights reserved.
