Achieving Rapid Success with a Flexible, Client-Centric Approach

By considering evolving client needs across operations Samsung BioLogics has rapidly become a leading biopharmaceutical CDMO.

Providing Fully Integrated Solutions 

Samsung BioLogics began as a large-scale contract manufacturing company — shortly after opening in 2011, we recognized the growing need in the industry for product development support and analytical testing services. Contract development services were added in 2017, and a variety of analytical testing capabilities have recently been integrated into our comprehensive offering. Today, we are a full end-to-end CDMO providing cell line development through commercial manufacturing of drug substance and product, all from a single location.

With these integrated services, Samsung BioLogics offers a faster and better path to IND filings and successful BLAs to clients worldwide. We provide phase-appropriate solutions guided by our track record of approvals and our technical operational model, supporting clients from the idea stage to the commercial product — all from an integrated campus.

Expanding Manufacturing Capabilities

In just eight years, Samsung BioLogics has designed, constructed and validated three manufacturing facilities. Plant 1 is an industry-standard facility with a total capacity of 30,000 L (6 X 5,000 L). Plant 2 has a total capacity of 152,000 L (10 X 15,000 L + 2 X 1,000 L) and incorporates minor engineering changes for improved efficiencies and processing capacity. With a total capacity of 180,000L (12 X 15,000L), Plant 3 is the largest single biopharmaceutical plant in the world and leverages all of the lessons learned through the operation of the two previous plants to achieve tremendous efficiencies.

These three plants are world-class facilities with bioreactors ranging from small to large scale and an innovative operating system that can address the diverse needs of our customers across the globe. Unique backup systems for our cleaning utilities ensure constant access to key utilities through limited to no shut-down periods. Additionally, all media can be heat-treated using the high-temperature/short-time systems installed in each plant.

Our process development labs were designed using the same concepts as our large-scale operations, ensuring the effectiveness of our scale-down models. Currently, clinical manufacturing can be performed in 1000-L stainless steel reactors, and a second unit containing two 1000-L single-use bioreactors will be operational by Q2 2020.

We now also have the ability to perform N-1 perfusion using an alternating tangential flow (ATF) device (3,000 L) in Plant 3. With the ATF system, we can effectively achieve higher cell culture densities (up to 10-fold) while retaining high cell viabilities (>98%) at the seed stage (N-1). Inoculation of the production bioreactors (15,000 L) then allows us to achieve peak cell densities within shorter culture durations, improving productivity and reducing production times.

Perhaps most notably, a fourth facility is in the planning stage. We are currently evaluating potential market developments and new technologies before selecting the best design and equipment options.

Going forward, Samsung BioLogics will continue to strengthen our presence in the rapidly growing global biopharmaceutical market by utilizing our world-class plant design and operational technology.

Increasing Complementary Services

In addition to development and manufacturing services, Samsung BioLogics has added — and will continue to add — key analytical services to help clients address major industry roadblocks for biologic drug production.

For both existing and new customers with marketed products, we offer stand-alone QC/QA testing services. We will also be bringing a new biological safety testing lab online, which will offer viral contamination, mycoplasma, endotoxin and sterility testing. Outsourcing analytical services can often be subject to delays in contracting and scheduling, which may become a bottleneck of the project. Through the opening of our in-house laboratory, we are able to provide faster turnaround on testing service and monitor analytical issues. Samsung BioLogics is also moving quickly to add master cell banking and other supportive services to meet the growing needs of clients.

Focus on Client Satisfaction

We operate under a client satisfaction model in which consideration of client needs drives business activities. Our focus is on understanding our customers’ requirements and finding ways to close any gaps that cause issues in biopharmaceutical manufacturing. One example of this customer-centric approach is our end-to-end practice of project management. The dedicated project manager and project team assigned on day-one stay with a project throughout its lifetime, ensuring the development of strong relationships and retention of process knowledge.

Creating Unique Contract Terms

Being part of the larger Samsung group enhances our customer satisfaction model, since we can tap into the broader organization and bring its capabilities and offerings to our clients — for example, leveraging Samsung engineering expertise in the design of our manufacturing facilities.

Samsung’s broader financial resources also allow us to create flexible, client-centric deals that maximize value creation for our clients. These innovative deals provide certainty of stable and reliable supply through the various development stages with optimized cost-effectiveness at commercialization through the implementation of creative commercial terms, and protecting clients if products fail
to advance.

Establishing a Leadership Position

Our success at achieving client satisfaction has been recognized for three consecutive years with CMO Leadership Awards (presented by Life Science Leader) for all six core categories: capabilities, compatibility, expertise, quality, reliability and service.

Going forward, Samsung BioLogics will continue to strengthen our presence in the rapidly growing global biopharmaceutical market by utilizing our world-class plant design and operational technology, which maximizes production efficiency and ensures stable supply of the highest quality products to patients worldwide.

In addition to our aggressive short-term plans to build a fourth plant in South Korea, we are evaluating options to establish a facility outside of the country to further expand our footprint. We will also continue to expand our development and testing services, adding capabilities that complement our manufacturing expertise and capacities with the goal of providing the most comprehensive, integrated, single source of client-focused support for biopharmaceutical research, development and production.

Daniel P. Slone

Dan Slone is a recognized industry expert with a demonstrated history of ~30 years working in biotechnology manufacturing and bioprocess. As a head of DS manufacturing for Samsung BioLogics, Dan is responsible for the overall operations and performance of upstream and downstream production. The responsibility of this position also includes ensuring leadership of GMP compliance in manufacturing operations, as well as regulatory site inspections in producing drug substances.