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Sourcing Inquiry Logo Samsung Biologics

Samsung Biologics

Regions
Worldwide
Countries
South Korea
Size
250-500
Specialty
Human Medicines, Biopharmaceuticals
Service category
Contract manufacturing, filling and packaging, Pharmaceutical process development and validation
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Key services

Services

Cell Culture

Six 5,000L production bioreactors capable of batch culture and fed-batch culture are currently being constructed. Two individual inoculation suites are designed for redundancy to reduce the risk of cross-contamination and minimize the required change-over time. Dedicated media preparation and hold tanks, based on bioreactor size, maximize operational control.
Our cell culture hall consists of three individual trains, each with dedicated seed reactors (40L/ 200L/ 1,000L) and two production bioreactors (5,000L). In addition to the large-scale bioreactors, our facility can accommodate clients with smaller scale production needs. Our facility has the capability to adapt to both centrifugation systems and depth filtration systems.
With the exception of our two independent inoculum suites (Grade B), the Cell Culture suites operate under a constant Grade C environment.

 

Core Competencies 

* State-of-the-art bioreactors (3X40L/ 3X200L/ 3X1,000L/ 6X5,000L)

* Wave bioreactors

* Sterilization-in-place (SIP) capacity with multiple clean-in-place (CIP) skids

* Dedicated automated glass washers and autoclaves

* Capacity for centrifugation and depth filtration

* Cell banking and storage with liquid nitrogen freezers

* Dedicated media preparation suite (Grade C) with down flow booth

 

Purification

The downstream process cGMP purification area offers four physically independent suites for maximum flexibility and minimum turnover time.
Each downstream suite can be adjusted to accommodate all customer process needs. All purification facilities are classified Grade C or higher.
The design minimizes opportunities for cross-contamination. Product integrity is supported by a column maintenance room, a Grade B bulk fill room, and physically separate dedicated equipment cleaning areas for pre- and post-viral equipment. The high-capacity buffer preparation suite is designed for temperature control and contains hold tanks sized to handle high protein titers. The downstream suites are equipped with chromatography skids, columns, UF/DF skids, virus filtration skids, and Grade A (laminar flow booth) bulk filling capacity. At Samsung BioLogics, all clean-in-place (CIP) and sterilization-in-place (SIP) operations are automated. Access to sensitive areas is restricted to an air-lock vestibule with interlocks.

 

Core Competencies

* Chromatography columns up to 1.4m in diameter

* Individual chromatography skids

* Ultrafiltration / Diafiltration and viral reduction systems (tangential flow filtration)

* Virus inactivation / Virus filtration

* Pre- and post-viral segregated design

* Dedicated bulk fill suite

* Dedicated automated glass washers and autoclaves

 

Fill & Finish

Samsung BioLogics’ cGMP filling facility is being furnished with state-of-the-art equipment: including formulation, aseptic liquid filling, pre-filled syringe lyophilization, and packaging apparatus.
Samsung BioLogics can provide packaging, labeling, and management logistics support for clinical trial products, plus all of the required documentation needed for market authorization and prompt delivery to clinics worldwide.

At a filling line, major processes are performed aseptically within a Restricted Access Barrier System (RABS). The integrated lyophilized product manufacturing services can accommodate a wide range of molecules, including peptides and monoclonal antibodies. A fully automated check weight system is applied to all products, and universally applied 2D matrix coding and verification systems ensures full traceability of all goods, maximizing In Process Control (IPC).

All processes are cGMP compliant and are designed to meet the regulations of the U.S. FDA and the EMEA. Samsung BioLogics’ dedication to quality shows in everything we do, and we are committed to delivering optimal services to all clients, from small scale batches for clinical trials, to large scale batches for commercial production.

 

Core Competencies

* Grade B based design

* Aseptic liquid filling of vials

* Aseptic lyophilization filling of vials

* Aseptic preparation of pre-filled syringes

* Capacity for an automated labeling, packaging and shipping area

* Dedicated wash room and media fill room

* Flexible and modular construction, with capacity for future expansion

Approvals, Certificates, Authorisations

  • cGMP compliant

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