The Korean CDMO announced its sustainable growth plan at this week's JP Morgan Healthcare Conference, which was held virtually from January 10 to 13.
John Rim, CEO of Samsung Bio, outlined the company’s vision for 2022 along with its business goals at the event, which saw contributions from the heads of the major pharma and biopharma firms along with executives from key life science investor groups.
“For Samsung Biologics, 2022 will be a year where we will be able to take a great leap forward for sustainable growth and endeavor to maximize our capabilities as a leading CDMO.
“Through proactive investment in increasing our manufacturing capacity, enhancing portfolio diversification, and expanding facilities in overseas, Samsung Biologics will be able to accelerate the build-up of its core success drivers as the next growth engine of the industry.”
Massive capacity boost on the cards
As part of its growth plan, the CEO said the CDMO is planning to start the construction of a new facility, Plant 5, this year, with a focus on cell and gene therapies and vaccines utilizing mRNA, pDNA and viral vectors, at that site.
This will be additional to the mRNA vaccine drug substance (DS) manufacturing suite the company is currently adding to its existing facility in Songdo, which is expected to be ready for cGMP operations within the earlier part of this year, said Rim.
It is also looking to secure additional sites within Songdo for the construction of Plant 6 and an open innovation center, as well as sites overseas in multiple locations to maximize both its manufacturing capacity to produce large-scale biologics and for it to be in close proximity to global clients.
Samsung Bio’s Plant 4 is currently under construction, with it set to be partially operational by the end of 2022. The company said it is steadily securing pre-sales from clients.
Upon full completion of Plant 4, scheduled for 2023, overall capacity at the organization will be 620,000L capacity, a development that will reaffirm its position as the world’s largest CDMO, it added.
Monoclonal antibody developmental support
Last year saw the CDMO sign strategic partnership agreements for the manufacturing of mRNA vaccines. It also launched its newest CDO process platform, S-Cellerate, which offers an expedited process for the development and commercialization of monoclonal antibodies.
Daniel Buckley, lead scientist in CDO downstream at Samsung Biologics, spoke to BioPharma-Reporter in December 2021 in relation to its S-Cellerate platform.
BPR: What was the background was to the development of the platform?
DB: As biologics in development get closer to commercialization, drug developers are expected to implement rigorous process control measures to avoid potential manufacturing inconsistencies in commercial production.
The S-Cellerate biologics development platform was created to offer an expedited process for the development and commercialization of monoclonal antibodies (mAbs) and other complex proteins.
S-Cellerate offers an accelerated CDO timeline to Investigational New Drug Application (IND) and a complete commercialization solution to reach Biologics License Applications (BLA) as two distinct services. So far, the platform is enabling clients to reach IND filings in as little as nine months while maintaining the highest product quality and operational robustness.
A thorough understanding of process parameters and their potential impact on the product quality attributes and safety profiles is critical for smoother more efficient transitions from IND to BLA.
BPR: How does the platform ensure optimization of processes, resources, and timelines?
DB: Speed to market is becoming increasingly crucial for commercial success. Enhanced timelines, which quickly advance the product to proof-of-concept (PoC) and first-in-human (FiH) studies, have already become the new normal. Our S-Cellerate platform represents the faster path to IND, achieved through careful optimization of processes, resources, and timelines to deliver top-quality biologics in record time.
Using a streamlined platform approach coupled with a fully integrated service offering, which includes aseptic fill/finish, labeling/packaging and CMC support, Samsung Bio teams can accelerate development speed without compromising on quality.
However, it is important to remember that throughout all phases of bringing a molecule to market, there are often differing priorities. Rather than overly focusing on one area, using a platform approach and ensuring an overarching strategy of process optimization will continue to prove the best method for the rapid delivery of drugs to market.
BPR: Can you expand on what the platform enhances in terms of the various steps involved from cell line development to IND filling?
DB: The S-Cellerate platform leverages our experience using design of experiments (DoE)-based methodology to obtain optimal productivity in cell culture, high yields, and improved quality in downstream processes. This also provides better safety and stability profiles in formulation development.
From cell line development to clinical supply, our clients can leverage end-to-end services from a single site to seamlessly enter clinical trials.
BPR: And how does the platform optimize the steps from process characterization to BLA submission?
DB: The S-Cellerate BLA platform offers the full spectrum of process validation services including well-designed process characterization (PC) and accelerated process performance qualification (PPQ). This enables Samsung Bio to:
- Execute service of development of medicines (SDM) qualification during phase I/III process development
- Execute PC for multiple unit operations in parallel
- Design PC using failure modes and effects analysis (FMEA) analysis and phase I data
- Establish qualified system models – from 1,000 L to 15,000 L
- Utilize multiple statistical analytics tools such as JMP and Design Expert
- Utilize multivariate data analysis (MVDA) software for large data processing for at-scale or SDM runs
- Utilize standardized ready-to-fill-in templates for regulatory submission
Successful scale-up to in-house commercial-scale facilities is achieved using highly optimized process control strategies designed to improve time and cost efficiency combined with speedy tech transfer. Our continuous process verification (CPV) strategy defines the key elements of a control strategy and assures quality life cycle control and continuous improvement across the entire commercialization journey.
BPR: How many contracts has Samsung Biologics won globally since it entered the CDO service market in 2018?
DB: We have won over 85 CDO contracts since the start of our business, with several of our clients engaging the S-Cellerate platform to expedite and accelerate critical drug programs.