Chemistry, manufacturing, and controls (CMC) are critical components that embody the entire development of a client’s drug product. Samsung Biologics has searched fervently for and ultimately sculpted its own customized CMC service based on strongly connected and seamless ideologies designed to close the gaps between development and commercialization. That must be achieved by meeting a client’s requirements exactly. Doing so has proven to be challenging for many CDMOs, especially because client needs change over time. Samsung Biologics addresses such challenges with its SelecTailor platform, an optimized scope-determination process in which we map out a coherent narrative of services to accommodate all possible needs.

Problems arise for some clients, when they do not fully understand their molecule and the developmental regulations that are relevant to their goals. Such uncertainties can lead to dead stops in determining the scope of work (SoW) or result in change requests (CRs) that go beyond the established SoW. Spontaneous CRs can have a number of negative impacts on a project. They might cause conflict in direction, impaired efficiency in communication, and increased cost, which can reveal unforeseen budget constraints. We address such uncertainties early before evaluating a bid for proposal.

We first ask, “What are the client’s aims and objectives in developing an investigational new drug (IND)?” To address those goals, we recommend following one of three modular packages.

The first package offers our Simplified IND, which prioritizes speed for a product that is in phase 1. Second, clients can choose a Comprehensive IND package, which assesses the IND molecule thoroughly in preparation for filing beyond phase 1 and through commercialization. Finally, our Enhanced CMC package provides an alternative cell line or process development and improves the quality and productivity of a client’s molecule, thereby reducing the costs of goods sold (CoGS). Efforts to optimize client procedures and address needs have reduced the number of CRs significantly speeding up bid evaluations and project rewards.

“Tailor-Select” Each Step From Beginning to End

Samsung Biologics uses a highly efficient, automated procedure to ascertain client needs swiftly before generating a relevant proposal. Answers to the technical questions that we ask clients during their request for information help us to mediate the selection process. The answers run through our internal algorithms to automate proposal generation. That helps us finalize a proposal quickly and informs the technical meetings we conduct to amend an automatically generated version later.

The SelecTailor Platform: Detailing the Three Packages

Clients will notice a profound difference when they transition their process from a Simplified IND to a Comprehensive IND or Enhanced CMC. The latter two options include a more sophisticated rewards package. Below, we explain how each package is structured, detail the unique benefits, and describe how the packages help clients meet their needs.

Simplified IND Package: This option prioritizes speed to phase 1 IND. To expedite the process, we conduct only those analytical tests that are required to support process development according to a client’s needs. The Simplified IND package’s prebuilt modules eliminate the need for time-consuming service integrations, which is helpful when a product pipeline requires early stage licensing. Although not as sophisticated as the Comprehensive IND or Enhanced CMC packages, the Simplified IND is streamlined for efficiency in delivery and leaves a project open to further service provisions.

Comprehensive IND Package: Our Comprehensive IND package takes the Simplified IND idea further. We ask clients if they need to determine whether their mandatory methods complement new orthogonal methods and a wider variety of analytical options. We ask how we can expand our horizons to gain a more scientifically complete understanding.

Figure 1: Samsung Biologics has structured its drug development services into three programs to meet client goals at every stage efficiently.

The Comprehensive IND package provides additional testing methods to establish a more fleshed-out, three-dimensional perspective on a client’s molecule. For example, in addition to automatically recommending host-cell DNA and protein for impurity analysis, this package includes residual protein A to minimize its leaching from the solid phase during capture chromatography in downstream process development.

From cell-line development to the downstream process, we recommend analyzing glycan and charge-variant profiles of each molecule. However, particularly during upstream process development, our specialized developmental platforms enable clients to optimize process parameters by modulating glycans and charge variants. We further modulated the charge-variants profile for one molecule to the client’s satisfaction during upstream process development.

When confirming a client’s release items, cell-based assays can be provided for testing at the current good manufacturing practices (CGMP) level. This is in addition to mandatory methods in Simplified IND and other methods for complementation. For characterization, we provide free-thiol analysis, dynamic light scattering, and IgG subclassification in addition to the basic analytical necessities.

By raising our certainty and insights, upstream process development also provides satellite runs from material supply runs and augments parameter studies as a preventative measure in preparation for scale-ups. Furthermore, when formulation development expands its scope to later stages, screening processes (for surfactant, pH/buffer, and so on) will encompass a wider array of candidates to minimize risk and increase the chances for approval. Not confined in terms of packaging, clients can enhance those elements further using our in-house DEVELOPICK assessment platform for late-stage discovery use.

Enhanced CMC Package: Sometimes, clients are dissatisfied when their early processes (from in-house methods or other service providers) inherently exhibit low expression titers and/or product quality. When such companies approach us for assistance, we can boost those attributes through the Enhanced CMC package. Clients have expressed satisfaction to us upon experiencing several-fold titer improvements after replacing their cell line with ours. We also have experience improving purification yields using process optimization strategies beyond phase 1 all the way through phases 2 and 3. Because this is the highest level of sophistication in our developmental-service provision, it includes the minimum recommended services, with a wider array of tests and process optimizations to achieve the required improvements that are part of our Comprehensive IND package.

Several options are available for clients who wish to improve their cell line, process, and formulation. We seek to minimize the CoGS at technology transfers during phases 2 and 3. In particular, this package accommodates reductions in CoGS through process changes upon commercial process lock before characterization. We achieve that, in part, by finding alternatives to high-cost chromatography resins.

We consider the physicochemical and biological properties of products — including potency — from cell-line development and confirm their comparability with manufacturing needs. Our formulation optimization and verification focus on tailoring clients’ processes based on their cell lines and the developmental context chosen for product improvement.

A Plan for Success

We created the SelecTailor platform to drive your success. Every client’s needs and objectives differ greatly, and we continually hone our insight and direction to accommodate a wide array of clients perfectly. We strive to design and deliver the best product possible to meet your needs.

Corresponding author Yeukyung Yoon is a lead scientist in the analytical development group, where she manages project SMEs as non-GMP analytics part leader ([email protected]) and Jangick Lee is a senior CDO business strategist ([email protected]), both at Samsung Biologics Co., Ltd, 300, Songdo bio-daero, Yeonsu-gu, Incheon, Republic of Korea.