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Manufacturing

Drug Substance

Samsung Biologics offers advanced cGMP facilities providing clinical and
commercial products based on mammalian cell culture. All processes are
cGMP-compliant and meet the regulations of U.S. FDA, EMA, and local
authorities. Samsung Biologics' dedication to quality and optimal services
is visible in everything we do, from small-scale clinical trials to large-scale
commercial production.

Cell Culture

Safe & Reliable Process

Our versatile Bioreactors, Media Prep Vessels (HTST available), Centrifugation, Depth Filtration, and CIP Systems are designed for minimizing cross-contamination.

Specification

  • Facility design based on gravity flow
  • Plant dedicated utility committed to providing constant power supply
  • Separate Flask Culture Suites (Made for Specific Products) Grade B environment with Grade A operational areas
  • Bioreactors : Fed-Batch, Perfusion (N-1 Step, Plant 3), Various Addition Lines, Wide range of Sparging, Single use/Stainless Steel bioreactor at N-4 step
  • Media Preparation : Various sizes of media prep vessels, HTST (High Temperature Short Time) Capability, Segregated Special Media Prep Area
  • Harvest : Capability of Large Depth Filtration Areas, Centrifugation Processing, and controls for Harvest Pool Vessels

Equipment/Capability

Cell Culture Facility Specifications items include division, Plant 1, Plant 2, CMP, Plant 3 and so on.
Plant 1 Plant 2 CMP Plant 3
Type Mammalian Mammalian Mammalian Mammalian
Total Capacity 30,000 L 150,000 L 2,000 L 180,000 L
Production Scale 5,000L (x 6)
Three Trains
15,000L (x 10)
Five Trains
1,000L (x 2)
15,000L (x 12)
Six Trains
Bioreactor Type Stainless Steel Stainless Steel Stainless Steel Stainless Steel
Development Stage cGMP late
clinical
& commercial
cGMP late
clinical
& commercial
cGMP clinical cGMP late
clinical
& commercial
Plant Specifications
  • Shaker or Magnetic Stirring Flask Culture
  • Hybrid Depth Filtration System (POD, Typical Lenticular)
  • Cultivation Type: Fed-Batch
  • Shaker or Magnetic Stirring Flask Culture
  • Lenticular Depth Filtration System
  • Cultivation Type: Fed-Batch
-
  • Shaker or Magnetic Stirring Flask Culture
  • Lenticular Depth Filtration System
  • Cultivation Type: Fed-Batch, Perfusion
Operational Q3 2013 Q1 2016 2H 2016 Q4 2018
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS, Health Canada
Cell Culture Facility Specifications items include Plant 1
Plant 1
Type Mammalian
Total
Capacity
30,000 L
Production
Scale
5,000L (x 6)
Three Trains
Bioreactor
Type
Stainless Steel
Development Stage cGMP late clinical &
commercial
Plant Specifications
  • Shaker or Magnetic Stirring Flask Culture
  • Hybrid Depth Filtration System (POD, Typical Lenticular)
  • Cultivation Type: Fed-Batch
Operational Q3 2013
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS, Health Canada
Cell Culture Facility Specifications items include Plant 2
Plant 2
Type Mammalian
Total Capacity 150,000 L
Production Scale 15,000L (x 10)
Five Trains
Bioreactor Type Stainless Steel
Development Stage cGMP late clinical
& commercial
Plant Specifications
  • Shaker or Magnetic Stirring Flask Culture
  • Lenticular Depth Filtration System
  • Cultivation Type: Fed-Batch
Operational Q1 2016
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS, Health Canada
Cell Culture Facility Specifications items include CMP
CMP
Type Mammalian
Total
Capacity
2,000 L
Production
Scale
1,000L (x 2)
Bioreactor
Type
Stainless Steel
Development
Stage
cGMP clinical
Plant
Specifications
-
Operational 2H 2016
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS, Health Canada
Cell Culture Facility Specifications items include Plant 3
Plant 3
Type Mammalian
Total
Capacity
180,000 L
Production
Scale
15,000L (x 12)
six trains
Bioreactor
Type
Stainless Steel
Development
Stage
cGMP late clinical &
commercial
Plant
Specifications
  • Shaker or Magnetic Stirring Flask Culture
  • Lenticular Depth Filtration System
  • Cultivation Type: Fed-Batch, Perfusion
Operational Q4 2018
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS, Health Canada

Purification

Maximum Flexibility & Minimum Turnover Time

Samsung Biologics’ cGMP Drug Substance Downstream Purification consists of two facilities with the newest equipment for cGMP operations, including chromatography (e.g., affinity, ion-exchange, multi-modal), viral filtration, ultrafiltration/diafiltration (UF/DF), and formulation and bulk filling operations. Both facilities consist of physically segregated pre-viral and post-viral suites designed for maximum flexibility and minimum turnover time.

Industry Leading Automation Solutions

Each downstream facility can be adjusted to accommodate all customer process needs. All purification facilities are classified as Grade C or higher. The design minimizes opportunities for cross-contamination with physically segregated pre-viral and post-viral suites containing equipment dedicated to cleaning areas and a Grade B bulk fill room. Three separate column packing suites support optimization of production cadence. The high-capacity buffer preparation suites are designed for temperature control and contain hold tank sizes to handle buffer preparations up to 15,000 L. The downstream suites are equipped with chromatography skids, columns, UF/DF skids, virus filtration skids, and Grade A (laminar flow booth) bulk filling capacity as well as product pool vessel capacities from 200 L to 15,000 L to handle a wide range of pool volumes and high protein titers. Our purification process is supported by industry leading automation solutions.

Specification

  • Facility design based on gravity flow
  • Plant dedicated utility committed to providing constant power supply
  • Chromatography : Affinity, Ion Exchange, Hydrophobic, Multi-modal
    Columns range : 0.8m to 1.8m in diameter Automation controls integrated with MCS Columns to accommodate all range of sizes
  • Dedicated equipment for Pre-Viral and Post-Viral areas for cross-contamination control COP and glassware parts washers Autoclaves Utility station with CIP and SIP capabilities for portable equipment CIP and SIP capabilities for all production equipment
  • VF Operation : Fully automated Hybrid design to accommodate any configuration
  • UFDF Operation : Fully automated
  • In line and off line Recirc vessel capability
  • Bulk Fill
  • Dedicated Grade B/A space

Equipment/Capability

Purification Specifications items include division, Plant 1, Plant 2, CMP, Plant 3 and so on.
Plant 1 Plant 2 CMP Plant 3
Type Mammalian Mammalian Mammalian Mammalian
Equipment
  • Chromatography Skids, Columns
  • UF/DF, VF Skids
  • Product Vessels
  • Buffer Prep. / Hold Vessels
  • CIP Systems
  • SIP full capacity
  • COP/GWD Cabinets, Autoclaves
  • Chromatography Skids, Columns
  • UF/DF, VF Skids
  • Product Vessels
  • Buffer Prep. / Hold Vessels
  • CIP Systems
  • SIP full capacity
  • COP/GWD Cabinets, Autoclaves
  • Chromatography Skids, Columns
  • Hybrid UF/DF skids
  • Single use VF skid
  • Product Pool Containers
  • Buffer Prep. / Hold Containers
  • Autoclaves
  • GWD
  • Chromatography Skids, Columns
  • UF/DF, VF Skids
  • Product Vessels
  • Buffer Prep. / Hold Vessels
  • CIP Systems
  • SIP full capacity
  • COP/GWD Cabinets, Autoclaves
Capacity/Capability
  • Small to large scale
  • Closed sampling
  • Chemical additions
  • Temp control 2-37℃
  • Class B/A Bulk Fill
  • Portable Equip stations
  • Cryo Freezing Tank/Bag/Bottle
  • Large Scale
  • Closed sampling
  • Chemical additions
  • Temp control 2-37℃
  • Class B/A Bulk Fill
  • Portable Equip stations
  • Cryo Freezing Tank/Bag/Bottle
  • Chemical additions
  • Temp Control 2-37 ℃
  • Class B/A Bulk Fill
  • 1 Purification Suites
  • Large Scale
  • Closed sampling
  • Chemical additions
  • Temp control 2-37℃
  • Class B/A Bulk Fill
  • Portable Equip stations
  • 2 Purification Suites
  • Cryo Freezing Tank/Bag/Bottle
Development Stage cGMP late
clinical
& commercial
cGMP late
clinical
& commercial
cGMP clinical cGMP late
clinical
& commercial
Operational Q3 2013 Q1 2016 2H 2016 Q4 2018
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS, Health Canada
Purification Specifications items include Plant 1
Plant 1
Type Mammalian
Equipment
  • Chromatography Skids, Columns
  • UF/DF, VF Skids
  • Product Vessels
  • Buffer Prep. / Hold Vessels
  • CIP Systems
  • SIP full capacity
  • COP/GWD Cabinets, Autoclaves
Capacity/
Capability
  • Small to large scale
  • Closed sampling
  • Chemical additions
  • Temp control 2-37℃
  • Class B/A Bulk Fill
  • Portable Equip stations
  • Cryo Freezing Tank/Bag/Bottle
Development
Stage
cGMP late clinical
& commercial
Operational Q3 2013
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS, Health Canada
Purification Specifications items include Plant 2
Plant 2
Type Mammalian
Equipment
  • Chromatography Skids, Columns
  • UF/DF, VF Skids
  • Product Vessels
  • Buffer Prep. / Hold Vessels
  • CIP Systems
  • SIP full capacity
  • COP/GWD Cabinets, Autoclaves
Capacity/
Capability
  • Large Scale
  • Closed sampling
  • Chemical additions
  • Temp control 2-37℃
  • Class B/A Bulk Fill
  • Portable Equip stations
  • Cryo Freezing Tank/Bag/Bottle
Development
Stage
cGMP late clinical
& commercial
Operational Q1 2016
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS, Health Canada
Purification Specifications items include CMP
CMP
Type Mammalian
Equipment
  • Chromatography Skids, Columns
  • Hybrid UF/DF skids
  • Single use VF skid
  • Product Pool Containers
  • Buffer Prep. / Hold Containers
  • Autoclaves
  • GWD
Capacity/
Capability
  • Chemical additions
  • Temp control 2-37 ℃
  • Class B/A bulk fill
  • 1 Purification suites
Development
Stage
cGMP clinical
Operational 2H 2016
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS, Health Canada
Purification Specifications items include Plant 3
Plant 3
Type Mammalian
Equipment
  • Chromatography Skids, Columns
  • UF/DF, VF Skids
  • Product Vessels
  • Buffer Prep. / Hold Vessels
  • CIP Systems
  • SIP full capacity
  • COP/GWD Cabinets, Autoclaves
Capacity/
Capability
  • Large Scale
  • Closed sampling
  • Chemical additions
  • Temp control 2-37℃
  • Class B/A Bulk Fill
  • Portable Equip stations
  • 2 Purification Suites
  • Cryo Freezing Tank/Bag/Bottle
Development
Stage
cGMP late clinical
& commercial
Operational Q4 2018
Regulatory
Compliance
Global HA including FDA, EMA, PMDA, MFDS, Health Canada

Drug Product

Samsung Biologics is equipped with a novel, state-of-the-art Fill and Finish facility
with aseptic filling, lyophilizers with automated loading and unloading, and
capping integrated within a Restricted Access Barrier System (RABS). All processes
are cGMP compliant and are validated to meet customer and regulatory
requirements and our drug product facility is designed to meet all FDA and
EU Annex 1 requirements for Sterile Drug Product Manufacturing. Samsung Biologics’ dedication to quality and optimal services is visible in everything we do, from small-scale clinical trials to large-scale commercial production. Global Health Authority approvals for Plant 1 by the FDA, EMA, NAVISA, COFERIS, MOIT and TITICK.

Fill & Finish

Samsung Biologics Development

Samsung Biologics provides Formulation services for Drug Product Fill and Finish.  Formulations can be completed from both single use systems or hard pipe systems.  Additionally, we provide optimized type formulations while securing stability and effectiveness for the customer within the time they need. We are also fulfilling customer satisfaction through development service that considers even the permitted articles following the relevant formulations.

Core Equipment
  • Small scale lyo
  • Down Flow Booth
  • DSC
  • Karl Fisher
  • Freeze Dryer Microscope
  • Manual Filler (Peristaltic Type)
Specialized Capability
  • Biopharmaceuticals
  • Monoclonal antibodies
  • Fusion proteins
  • Bispecific antibodies
  • Packaging (Vials)
  • Proteins
  • Peptides
  • Formulation process optimization based on QbD

Thaw

Equipment
  • Freeze/Thaw skid for cryovessels
  • Freeze/Thaw skid for cryobags
Capacity/Capability
  • Controlled freezing and thawing
  • Max. capacity : 1 tank per station
  • Temperature range : -70ºC to 40ºC

Formulation

Plant 1
Equipment
  • Excipient and formulation vessels
Capacity/Capability
  • Excipient vessel capacity : 20L to 3,000L
  • Formulation vessel capacity : 20L to 1,500L
  • pH and temperature control
  • Weight control
  • CIP/SIP of excipient and formulation vessels
  • Single use solutions capabilities
Plant 2
Equipment
  • Excipient and formulation vessels
Capacity/Capability
  • Excipient vessel capacity : 200L to 2,000L
  • Formulation vessel capacity : 200L to 2,500L
  • pH and temperature control
  • Weight control
  • CIP/SIP of excipient and formulation vessels
  • Single use solutions capabilities

Vial Preparation and Filling

Plant 1
Equipment
  • Washing, depyrogenation, vial filling
  • Stoppering, capping, transfer to lyo
Capacity/Capability
  • Active RABS
  • Filling rate : up to 12,000 vials/hr
  • Filling operation range : 0.1 ~ 100ml
  • Pump types : piston and peristaltic
  • CIP/SIP of vial filling machine
  • 2mL to 50mL vial size
  • GRADE A over sealing
  • Adaptable process to include single use or fixed systems
  • Inline IPC capability (non-destructive testing)
Plant 2
Equipment
  • Washing, depyrogenation, vial filling
  • Stoppering, capping
Capacity/Capability
  • Active RABS, Piston & Peristatic Pump
  • Max. capacity : 300 vials/min (based on 10ml vial)
  • Filling operation range : 0.1ml to 100ml
  • 100% weight check system
  • CIP/SIP of vial filling machine
  • GRADE A over sealing (enclosed RABS)
  • Adaptable process to include single use or fixed systems

Inspection

Manual Inspection
Equipment
  • Manual inspection Booths
Capacity/Capability
  • Comprehensive visual inspection program
  • Operators' manual inspection qualification
  • Product type : liquid, high viscosity, and lyophilized
  • Defect classification library and qualification programs developed for all product types
  • Vial cap printing capabilities available
Semi Automatic and Automated Inspection
Equipment
  • Automated inspection line
Capacity/Capability
  • Line speed : 12,000 vials/hr (20R vial)
  • Uses Charge Coupled Device (CCD) camera system to identify vial defects, product defects, closure defects, etc.

Packaging

Equipment
  • Manual bulk packaging
Capacity/Capability
  • Line speed : 18,000 vials/hr (30mm diameter vial)
  • Pakaging type : labeler, cartoner, overwrapper
  • Laser carton print system
  • Automatic weight check unit between cartoner and overwrapper
Packaging Packaging

Lyophilization

Equipment
  • Two(2) lyophilizers
Capacity/Capability
  • Max. loading capacity : 32,000 vials (10ml) per lyo
  • Ice load capacity : 300kg
  • Shelf area : 16.7 ㎡
  • Automatic loading and unloading system with RABS

Lyophilization Cycle Development and Commercial Scalability

Lyophilized product design

Product characterization

  • Thermal characterization of product (Tg, Tg’, Teu,Tc)
  • Characterization of freezing step (crystalline or amorphous)

Finished product analysis specific to lyophilized products

  • Karl Fisher moisture
  • Physical appearance
  • Attributes of constituted solution (time, clarity, PM)

Lyophilized formulation development support

Manufacturing of small-scale batches for development stability

Troubleshooting commercial processes

Product impact assessment

Support Processes

Terminal Sterilization

Equipment
  • Terminal sterilizer
Capacity/Capability
  • 8000L chamber capacity
  • Max. capacity : 2R vials 180,000, 6R vial 90,000, 10R vial 68,000, 20R vial 43,000
  • Vacuum pulse and air/Steam mix

Leak Detection

Equipment
  • Leak detector
Capacity/Capability
  • 12,000 vials/hr (20R vial)
  • Includes Headspace Analysis (HSA), Pressure Decay and Vacuum Decay
  • Liquid and lyophilized vials

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Samsung Biologics
Privacy Policy

초점받기 링크
Effective Date: [30Dec2019]

This Privacy Policy illustrates how Samsung Biologics ("we", “our”, “us”) use and protect information you provide through your use of this website (the "Website") or our customer inquiry and recruitment services (collectively the “Services”).

Please read this Privacy Policy carefully and feel free to contact us if you have any questions, using the contact information provided in the Contact Us section below.

Information we may collect from you
1.Customer Inquiry

When you fill out the “Contact Us Form” on our Website, we may collect the following types of information:

  • Customer Inquiry information include Category, Information we may collect from you.
    Category Information we may collect from you
    Contact Us Mandatory Name, E-mail Address, Company Name, Occupation, Country, Areas of Interest, Inquiries/Comments
    Optional Any additional information you provide including but not limited to the job title
    Customer Inquiry information include Category, Information we may collect from you.
    Category Information we may collect from you
    Contact Us Mandatory Name, E-mail Address, Company Name, Occupation, Country, Areas of Interest, Inquiries/Comments
    Optional Any additional information you provide including but not limited to the job title

    Access log and website usage information collected through cookies. For more information about how we use cookies on our Website, please see our Cookie Policy.

2.Recruitment

When you submit your application via “TalentPool” on our Website, we may collect the following types of information:

  • Recruitment infomation include Category, Information we may collect from you.
    Category Information we may collect from you
    Talent Pool Mandatory Name, E-mail Address, Country, Areas of Interest, Resume
    Optional Any additional information you provide including but not limited to personal profiles on SNS
    Application Form
    (in Korean)
    Mandatory Name, Date of Birth, Address, E-mail, Contact Number,
    Education History (Name of School, Major, Enrollment Year/Month, Graduation Year/Month, Location), Employment History (Employment Period, Company, Job Title, Job Scope, Major Task), Language, Miscellaneous (Military Status, Reason for Exemption, Veteran Status)
    Optional Any additional information you provide including but not limited to research career, special qualifications and licenses, personal profiles on SNS.
    Recruitment infomation include Category, Information we may collect from you.
    Category Information we may collect from you
    Talent Pool Mandatory Name, E-mail Address, Country, Areas of Interest, Resume
    Optional Any additional information you provide including but not limited to personal profiles on SNS
    Application Form
    (in Korean)
    Mandatory Name, Date of Birth, Address, E-mail, Contact Number,
    Education History (Name of School, Major, Enrollment Year/Month, Graduation Year/Month, Location), Employment History (Employment Period, Company, Job Title, Job Scope, Major Task), Language, Miscellaneous (Military Status, Reason for Exemption, Veteran Status)
    Optional Any additional information you provide including but not limited to research career, special qualifications and licenses, personal profiles on SNS.

*No sensitive information will be collected.

How we use your information
1.Customer Inquiry

We may use the information we collect from you to conduct certain services or activities such as replying to inquiries, maintaining business records, and conducting market research.

2.Recruitment

In order to proceed with recruitment process and communicate status/result of job application(s).

Sharing information with third parties

We will not disclose your information to third parties for their marketing or business purposes without your consent. However, notwithstanding the above, we may disclose your information to the following entities for recruitment purposes:

  • Educational institutions in your application.
    Your information (name, date of birth, major, admission year, graduation year, etc.) may be disclosed to educational institutions named in your application.
  • Previous companies you worked for and reference check vendors.
    Your information (i.e. name) may be disclosed to your previous workplaces and reference check vendors.
  • Service providers.
    We may disclose your information to companies that provide Services on our behalf. These entities cannot use your information for purposes other than providing Services on our behalf.
  • Other parties when required by law or as necessary to protect our rights.
    There may be instances where we disclose your information to other parties:
    • - to comply with legal obligations or legally binding disclosure orders (such as a search warrant or other court/regulatory order);
    • - to verify or ensure compliance with the terms and policies governing our Services; and
    • - to protect the rights, property, or safety of us or any of our business partners or customers.
  • Other parties in connection with corporate transactions.
    We may disclose your information to a third party as part of a merger or transfer, or in the event of a bankruptcy.
  • Other parties with your consent or at your direction.
    In addition to the disclosures described in this Privacy Policy, we may disclose information about you to third parties when you consent to or request such disclosure.
Your Rights

To the extent permitted under applicable law(s), you may ask us to return, destroy, or correct any inaccuracies regarding your personal information. You may also ask us to restrict or limit our use of your personal information unless such restriction or limitation prevents us from complying with applicable law(s) or meeting a legal obligation.

However, your rights above may be limited in cases where your request would disclose personal information of a third party or where such a request would infringe the rights of a third party (including our rights) or if you ask us to delete information which we are required by law to preserve or have legitimate interests in retaining. Other relevant exemptions may exist under the GDPR and national laws. We will inform you of the relevant exemptions when responding to your request. To make such a request concerning your rights set forth herein, please refer to the Contact Us section below.

International Transfer of Information

We are a company based in Korea, and your use of our Website and Services will involve the transfer, storage, and processing of your personal information in Korea. Please note that the information protection laws and other applicable laws of countries outside the European Economic Area (“EEA”), to which your information may be transferred, might not be as comprehensive as those in your country. We will take appropriate measures, in compliance with applicable law, to ensure that your personal information remains protected. Such measures include the use of EU Standard Contractual Clauses to safeguard the transfer of information outside of the EEA or other methods. For more information, please contact us at privacy.bio@samsung.com.

Data Retention

We will retain your personal information for a reasonable period of time that enables us to communicate with you, to provide you with Services, to maintain business records for audit purposes, to meet recordkeeping requirements under applicable law(s), to defend or bring any legal claims and to deal with any queries or complaints you may have.

Keeping Your Information Secure

We have put in place reasonable measures to safeguard the information we collect in connection with the Services. However, please note that although reasonable steps will be taken to protect your information, no website, internet transmission, computer system or wireless connection is 100% secure from any and all potential threats.

Personal Information – Children under the age of 13

The Services are designed for general audience and are not intended or directed to children.

For US Residents Only

In connection with the Services, we will not knowingly solicit or collect personal information from children under the age of 13. In the event we do collect such personal information inadvertently or unknowingly and we later learn about it, we will promptly delete such information. If you believe that children under the age of 13 may have provided personal information to us, please contact us using the Contact Us section of this Privacy Policy.

If You are an individual resident in the EU

We process your personal information on the legal grounds that the processing is :

  • Necessary for the performance of contractual obligation(s) between you and us, for example if we’re providing service(s) that you have requested;
  • Necessary for compliance with our legal obligations;
  • Necessary for our legitimate interests, such as preparing our communications to you and continuing to develop and improve our services; or
  • With your consent or at your direction.

If you do not provide certain information to us, we may, in some circumstances, be unable to comply with our obligations or provide you with the services that you request. We will inform you of the implications of not providing certain information.

As set forth in the “Your rights” section, you are entitled, in accordance with applicable law, to object to or request restriction of processing your personal information, and to request access to, correction of, or deletion of your personal information. When we use your information on the basis of your consent, you have the right to withdraw such a consent at any time. Any requests should be submitted in writing to the address listed below in the “Contact Us” section. You also have the right to file a complaint with data protection authorities.

Contact Us

If you have any questions about this Privacy Policy, please contact us using the details below.

- Contact : 032-455-9829

- Email : privacy.bio@samsung.com

Changes to this Privacy Policy

We may update this Privacy Policy from time to time. When we update the Privacy Policy, we will revise the “Effective Date” above and post the new Privacy Policy with a new date. We recommend that you review the Privacy Policy each time you visit our Website to stay informed of our most current practices and policies.

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  • This page is created for reporting core technology and management information leakage.
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