Leveraging end-to-end manufacturing solutions with scale, capability, and flexibility

Building a solid commercial drug strategy is centered on engaging partners strategically and at the earliest stage possible. Drug developers need partners with a wide range of experience that can guide their products to successful commercialization as each milestone is a critical step and any sort of disruption can cause severe loss in cost and time, and consequently, in delivering to patients in need. Samsung Biologics’ aseptic fill-finish services are expertly aligned and optimized to the client’s needs throughout the development and commercialization journey.

Whether it is for near-final finished drug products for clinical supply or capabilities to ramp up production to meet post-approval demand, Samsung Biologics’ capabilities provide the flexibility to deliver both clinical and commercial supplies to clients with economies of scale.

Flexibly catering to client needs through a wider range of service offerings

From the beginning, Samsung Biologics engineered its fill-finish and lyophilization capabilities, technology, and dedicated project management team to deliver the speed, quality, and competitive pricing the industry is asking their strategic drug manufacturing partners to deliver—and that includes on-time, in-full delivery of their product.

Samsung Biologics operates two filling lines: one with aseptic filling and lyophilization capabilities, and the other with aseptic filling capability only with additional lyophilization capabilities to be operational in 2022 in order to meet the increasing demand. Both production lines have a single-use and stainless steel formulation system for filling capabilities.

Both lines have Grade A environments for aseptic filling from depyrogenation through capping, and also non-destructive in-line fill weighing systems. The facility maintains manual, semi-automated, and fully automated inspection processes.

Acceptable Quality Level (AQL) is subsequently performed by qualified QA inspectors for inspected vials.

After visual inspection, products are both packaged and stored in the facilities’ integrated, qualified warehouse cold rooms with temperatures ranging from 2 to 8℃, -20°C, -40°C, and -70℃. All Samsung Biologics GMP warehouse facilities are validated and monitored 24/7/365 days a year.

Quality-assured through solid track record in regulatory approvals and enhanced digital quality systems

Since Samsung Biologics began providing GMP manufacturing services, the company has accumulated a solid regulatory track record with 32 product approvals within 5 years from global regulatory bodies, including the FDA, EMA, and PMDA.

To further bolster its high-standard services, Samsung Biologics launched its Enterprise Quality Unified Information System (EQUIS), which integrates two separate systems—Electronic Document Management System (EDMS) and Electronic Quality Management System (EQMS)—into one.

As a secure, cloud-based platform, EQUIS allows qualified employees to manage quality records and documents in real-time on a single platform, ultimately improving cGMP record tracking, documentation, and assessment for the projects Samsung Biologics runs. The system provides its clients direct and secure access to request, review, and approve documents and records related to their products on-demand.

Faster delivery enabled by fully integrated, end-to-end service offerings

Overall supply chain timelines can be reduced significantly due to the tight integration available between the company’s Drug Substance manufacturing (DS) and aseptic fill-finish operations.

By expediting forward-processing between DS and aseptic fill-finish, Samsung Biologics is able to deliver products to clients faster and more efficiently. Its dedicated MSAT Laboratory that specializes in DP processing has the capability to conduct multiple studies and run pilot scales as a measure of risk mitigation and process optimization. Analytical methods from DS can also be leveraged for aseptic fill-finish. Moreover, Samsung Biologics has a full repertoire of in-process lot release testing methods, which provides clients with quicker release times and reduces the need to establish alternative testing laboratories.

This helps the company to reduce the aseptic fill-finish tech transfer duration to an average of three months - faster than the industry average without compromising quality – depending on the project and program goals.

Aseptic fill-finish operations are thoroughly integrated with quality operations to accelerate throughput and reliably achieve product release in 30 days for commercial batches, a production timeline that enables accelerated time to market and to patients.

Reinventing the client experience through communication and collaboration

Samsung Biologics has taken measured but advanced approaches to its business practices in delivering optimized efficiency through high levels of automation and increased client satisfaction.

All of Samsung Biologics’ efforts have gone into reinventing the client experience, and fostering an environment where a client-centric service with open communication and close collaboration is integral.

Experienced project management also means faster, seamless delivery of programs, large or small. When scope, schedule, change, and communication management are all aligned, it can transform and positively impact the overall client experience and success of a client’s most challenging project.

Working to enrich human lives, Samsung Biologics’ expertise and innovation in biotechnology has allowed it to focus on accelerating excellence for its clients. The ultimate mission for Samsung Biologics as a global, end-to-end CDMO is to deliver finished drug products as quickly and efficiently as possible so that important therapeutics can reach patients reliably and safely.

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