SAMSUNG BIOLOGICS VIRTUAL EXHIBITION

Total
General
Capabilities
Regulatory/Quality
Client/Project
Business
cGMP Manufacturing
Development Service
Regulatory documents
Timeline
BTS
cQC

Q
General Can you provide Samsung Biologics' history?

A

Samsung Biologics was founded in 2011, and our first plant was operational by 2013. Quickly after that, our 2nd Plant was added in early 2016, and now that P3 is also up and running, the total capacity reaches 364KL.
To date we've produced over 600+ successful batches and have multiple approvals from the FDA, EMEA, and PMDA for multiple products.
Q
General Company Management - Describe your leadership/management?

A

Our leadership team is comprised of experienced leaders from the biopharma industry and seasoned professionals from Samsung.
As an example our CEO was also the founder of Samsung Biologics and has over 30 years experience in Samsung building and running plants and manufacturing operations. Our head of Quality and the quality leadership team are experiened industry professionals from companies like Genentech, J&J, and others. In addition our heads of Cell culture, Purification, and Drug Product manufaturing are all experienced leaders from the biopharma industry.
Q
General Please describe your company's business model.

A

Samsung Biologics is committed to excellence in the development and manufacturing of life-saving biologics such as antibodies.
Our client-oriented business model encourages high-standard, fast-turnaround contract manufacturing partnerships.
Furthermore, our state-of-the-art facilities are fully compliant with global healthcare regulations and Current Good Manufacturing Practice (cGMP) standards.
To better serve the patients of our partners, we provide the proper infrastructure to develop, refine, and distribute biopharmaceutical products worldwide. Samsung Biologics’ business is focused on end to end, single site integrated services from cell line development through aseptic fill/finish.
Q
General What brought Samsung to the biologics field?

A

Our current CEO, Dr.TH Kim was tasked with finding the next growth engine for Samsung.
He quickly discovered that the field of biologics not only has strong growth momentum but also shares our philosophy of devoting our resources and technology to create superior products and services, thereby contributing to a better global society.
With Samsung's long standing success & experience in highly tech-driven semiconductor business, Samsung leveraged its engineering and management capabilities with agility to bring another meaningful step forward in the biotech/healthcare industry.
Q
General Where is Samsung Biologics located?

A

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Q
Capabilities Overview of Capabilities

A

Our capabilities include everything from cell line development to fill and finish.
This includes process and analytical development, DS manufacturing of clinical and commercial phase mammalian biologics, liquid and lyo fill finish, and comprehensive analytics support including stability testing.
Q
Capabilities Samsung Biologics Capacity for DP

A

Both Plant#1 and Plant#2 are capable of aseptic fill and finish of liquid vials.
Plant #1 can also provide lyophilization service. (Plant #2 is planned for Lyo)
We can fill any size vial up to 100 ml , with max. loading capacity at 32,000 vials (10ml) per lyo
Q
Capabilities Samsung Biologics Capacity for DS

A

We have three large-scale plants, all in stainless steel in full operation:
P1 has 6 x 5000 liter bioreactors
P2 has 10 x 15000 liter reactors.
Our newest and largest plant, P3 has 12 x 15,000 bioreactors. Capable of N-1 Perfusion technology
All are mammalian-cell based bioreactors.
We also have small-scale CMO Plant with 4 x 1,000 liter bioreactors.
We can accommodate the clients' requested scales and needs to grow together as demand increases.
Q
Capabilities What is your total annual capacity for DS?

A

Samsung Biologics has a total of 364,000L of mammalian biopharmaceutical manufacturing capacity across three plants at the Songdo site in South Korea.
Slot allocation and capacity availability depend on binding amounts from forecast of projects in each plant.
Q
Regulatory/Quality How many inspections/product approvals does Samsung Biologics have?

A

We have 22+ inspections and total 51+ regulatory approvals for both drug substance and drug product from global regulatory agencies including FDA, EMA, PMDA, Health Canada and 15+ additional regulatory agencies. Since our first approval in 2016, Samsung has not received any FDA warning letters or any critical GMP non-compliance warnings including 483.
Q
Regulatory/Quality How many PAIs have you hosted?

A

Samsung Biologics has hosted 20 PAIs since 2015, including 7 FDA, 5 EMA and 2 PMDA.
Q
Regulatory/Quality Please describe your Quality policy

A

Samsung Biologics ensures the highest quality outcome through operational excellence based on our Quality Management System (QMS).
Our QMS establishes high standards for planning of quality outcomes, execution of the planned activities, monitoring and measurement of the results, analysis of the data, and correcting or improving those activities where needed.
Samsung Biologics’ Quality Unit functions independently from operations. The Quality and Compliance department is responsible for ensuring that all cGMP processes comply with regulatory guidelines and requirements. The Quality Management System ensures that our products are of the highest quality, and that all equipment and systems are maintained throughout cGMP production.
Q
Client/Project Please describe how you manage projects/partnerships

A

Samsung Biologics has dedicated Project Management Teams for each project and client supporting both DS/DP. With project kick-off F2F, a dedicated project management team (PMT) will be organized to oversee the entire lifecycle of the project. Your assigned BD manager will be with you every step of the way and will ensure that your program goals and alignment are continually monitored to meet your over all program success.
PMT consists of project manager (PM) and Subject Matter Experts (SMEs) from relevant departments (Drug Substance Manufacturing, Process Development, Manufacturing Science and Technology, Quality Control, Quality Assurance, Validation, Supply Chain, and others as needed). Final composition of PMT and JSC shall be defined within the Master Supply Agreement (MSA).
Q
Client/Project Typical leadtime (timeline) for technology transfer, estimate manufacturing and regulatory filing lead times and forecast requirements

A

Samsung Biologics is capable of going from tech transfer initiation to first GMP run (mostly Engineering run) in approximately 6 months, and may require extra time if the process is unique or demanding specific equipment adjustment. We possess the vast majority of standard equipment for upstream and downstream to cover diverse manufacturing process per client requests. Samsung Biologics can achieve regulatory submission in as little as 18 months.
We typically require a 2 year forecast to reserve capacity; however, additional flexibility can be accommodated if required.
Q
Client/Project Who are your existing clients?

A

Samsung Biologics has partnerships with 30+ global clients; big pharmas, mid-sized biotechs and small/virtual companies. Our publicly disclosed clients include F. Hoffmann-La Roche Ltd., Bristol Myers-Squibb, UCB Biopharma SPRL, GlaxoSmithKline, and Sun Pharmaceutical Industries, Ltd.
Q
Business Are all activities performed in Korea?

A

Our headquarters is located in Korea, and our R&D site expansion is currently ongoing in San Francisco. We will continue our expansion to global bioclusters for the benefit of our global partners.
Q
Business How does project management work?

A

We have a dedicated PM for each project. For development projects, regular meetings and/or T/Cs are organized periodically (bi-weekly, monthly, or completion of development stage) for updates and technical discussion on development progress.
Q
Business Is an onsite audit available?

A

Yes, our clients can visit our facility for an audit if needed either in person or virtually in real-time using our Live Virtual Tour platform. Additionally, pre-recorded virtual tours are available on our website.
Q
Business What is the development project track record of Samsung Biologics?

A

Since the recent launch and impressive growth of our CDO business, we have accumulated over 53 development contracts from all around the globe.
Q
Business What is the service price for the whole (Cell line development to cGMP manufacturing) CDO service?

A

We provide competitive pricing to our clients. As our pricing varies based on molecule types and SoW, please contact us for more details.
Q
cGMP Manufacturing Are there any conditions for manufacturing at 3rd party starting from GMP production of phase 1?

A

Yes - our main goal is strong client satisfaction.
As a client-centric organization, there are no specific restrictions or conditions for reaching out to other vendors for GMP production. However, timeline-wise, for more efficient production, manufacturing at our site with flexibility in capacity and timeline is highly recommended.
Q
cGMP Manufacturing What are the sizes of the clinical manufacturing bioreactors?

A

Currently SBL has 1KL stainless steel and single-use bioreactors. Using these facilities, we can manufacture 200L/500L/1KL scale.
Q
cGMP Manufacturing What is the minimum scale of bioreactor for development?

A

2L and 10L in non-GMP condition are the minimum scale bioreactors. Samsung also uses Amber15 for media screening.
Q
Development Service Can Samsung produce a chemical-conjuaged antibody like ADC?

A

We can provide naked antibody manufacturing service for ADC. We do not provide linker/conjugation service.
Q
Development Service Does Samsung have experience with bispecific antibodies?

A

Samsung has developed a number of atypical biologics products, including different forms of bispecific antibodies and fc fusion proteins with titer greater than the industry average. Please refer to Our Technology link for more details.
Q
Development Service What is Samsung's development timeline?

A

Standard development timeline is 14.5 months, and fast timeline is 10.5 months. For more details, please refer to our performance link.
Q
Regulatory documents Are the documents written in English?

A

English is the official language in all our operations. All documentation are written in English.
Q
Regulatory documents Does Samsung support documentation?

A

Samsung Biologics supports regulatory documentation for IND filing. Please refer to Regulatory Support link for detail list of documents prepared by Samsung.
Q
Timeline Is the timeline fixed, or can it be customized if necessary?

A

The timeline can be customized based on the product, customer's schedule or other factors.
Q
Timeline What is the risk behind the fast track timeline?

A
The fast track timeline is introduced to clients who want to go into preclinical or clinical studies as soon as possible for certain reasons - it is based on the client's development strategy. For more details, please go to the timeline link.
Q
BTS Is 14 days method also offered for in vitro adventitious assay?

A

Yes, general service includes 28 days method, a basic compendial method. Starting from June 2020, 14 days method will also be offered.
Q
BTS What are track records and/or regulatory inspection history for Biosafety Testing Service?

A

In October 2019, the BTS laboratory was also inspected as a part of site inspection by the FDA and achieved no observation. In addition, multiple client audits were completed successfully since the launch of our Biosafety Testing Service.
Q
BTS What is the deliverable of the Biosafety Testing Service?

A

After Biosafety testing, a Certificate of Analysis is issued. In addition, we also provide a plugged-in form of test report, including details such as test summary, acceptance criteria, test description, etc.
Q
BTS What is the expansion plan for the Bioanalytical Testing Service business?

A

Bioanalytical Testing Service will expand its service scope into virus clearance test, cell banking & storage service in a few years.
Q
BTS What is the TAT (turnaround time) for Biosafety Testing?

A

TAT for major Biosafety Tests includes cytotoxicity test, main test, QA review, client review, report preparation, and final report sharing. (In case of Routine test, cytotoxicity test is excluded),
- Mycoplasma detection: MST (42TAT), Routine (35TAT)
- in vitro adventitious assay (28Days method): MST (45TAT), Routine (35TAT)
- MVM DNA detection: MST (21TAT), Routine (14TAT)
Q
BTS When performing in vitro adventitious assay, what types of indicator cell lines covered?

A

We can use CHO (Mouse), Vero (Monkey), MRC-5 (Human), A9 (Mouse) cell lines. Also, upon client request, other indicator cell lines are incorporated after method validation.
Q
BTS Which method is used for mycoplasma detection?

A

Based on EP/USP guidelines, Culture (Direct) / qPRC (Indirect) method is used. An additional method according to JP guidelines will also be provided in the near future.
Q
cQC For what types of products can you provide cQC service?

A

In addition to Biologics and Biosimilars, small molecule products can also be tested by our cQC service to launch in the domestic market.
Q
cQC How long does it take to tech transfer for cQC service?

A

It can vary depending on the need for new equipment and the number of test methods, but for biologics with an average of 15 analytical tests will usually take about eight months.

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