True excellence in contract drug development lies in an outsourcing partner’s ability to consistently act on its commitments across every stage of the project lifecycle. Among these commitments, clear and proactive communication is the foundation for achieving client trust and long-term satisfaction. 

Regulatory authorities have encouraged drug developers and their partners to communicate consistently, suggesting that this is critical for maintaining the efficacy and stability of a molecule from cell line through process development to manufacturing and market entry.

One fundamental chemistry, manufacturing, and controls (CMC) guideline is to “assure that the quality of the drug meets appropriate standards and is consistent [from lab to market],” according to the U.S. Food and Drug Administration (FDA). Samsung Biologics, a global contract development and manufacturing organization (CDMO), has incorporated this guideline into its culture of exploration, persistence, and adaptability, which has cascaded from industry veterans to early-career scientists and from the CDMO to its clients, building a track record of drug development success as one team.

“Communication with peers and clients is the most important value I emphasize to my team,” says Sojeong Lee, a director of upstream development at Samsung Biologics. “We, as a trusted partner, need to be exploratory to analyze molecules, persistent to identify and resolve the root cause of issues, and flexible to accommodate change requests and project modifications.

“It is all made possible through consistent communication within my team and with our partners.”

Overcoming CMC challenges via cross-team collaboration

An industry veteran who has guided global biotechnology and pharmaceutical companies in advancing their molecules to clinical approval, Lee says transparent and agile communication is the default for interacting with clients in need of CMC support.

                 Sojeong Lee, director of upstream development,  Samsung Biologics                  

“CMC, from the perspective of our clients, is their asset,” she says. “Whether the development is for a traditional antibody or a complex molecule, challenges can appear randomly at any stage. Therefore, we need to consistently discuss, strategize, and work with our clients to mitigate uncertainty and stay on track.” 

Last year, Lee’s team discovered an accumulation of byproducts during the manufacture of materials for a toxicological study. Recognizing that the culture profiles used in the toxicology material production would not sustain the necessary productivity and quality for GMP manufacturing, she immediately invited the client to a discussion with her colleagues from the cell line/process development, analytical, and quality teams to collaboratively optimize the process for greater scalability and robustness.

Through frequent ad hoc meetings, the Samsung Biologics team, in close collaboration with the client, molded various insights into a tailored strategy. As a result, the team reinforced the process to ensure that materials were produced in accordance with the client’s critical quality specifications without disrupting the original timeline.

“Collaboration is critical, especially when time is limited,” Lee says. “Scientists across teams need to consistently exchange their opinions with one another so they can draw up comprehensive CMC solutions tailored to specific molecules.”

To be reliable partners that meet specific client needs, scientists at every stage of their careers must commit to ongoing, rigorous training, she says. “At Samsung Biologics, that mindset is part of our culture.”

Jaewook Baek (left), senior scientist in process development, with Lee (right) in an upstream development lab

Jaewook Baek, a senior scientist in process development, says that holistic collaboration with his peers and the client was key to successfully redesigning the design of experiment (DoE) that addressed the critical quality attributes of the client’s product.

“We only had one chance to redesign the DoE, or the project timeline would have been at risk of being delayed,” he says. “What was critical at the time was how naturally scientists from both our and the client’s side communicated around the clock, filling in for one another and building mutual trust. Every development project brings new challenges, but we train and help each other as a team, preparing to clear CMC roadblocks.”

When a culture of communication and growth meets advanced technologies and diverse platforms, scientists across all levels become adept at resolving complex, time-sensitive challenges.

Several months ago, the Samsung Biologics team was assigned to help another client select the most optimal bispecific antibody (bsAb) sequence within an expedited timeline. As a first step, Lee and her colleagues established a direct communication hotline to engage with the client in real time. The team then leveraged accumulated project expertise and data-driven know-how to develop a customized testing strategy that addressed the unpredictable and unique characteristics of the client’s bsAb. A series of in-depth discussions through the hotline, along with one-team execution, refined the strategy. Ultimately, in two months, the team successfully identified the most viable bsAb sequence among five candidates using its high-throughput developability assessment platform, DEVELOPICK™. 

“The client did not hesitate to ask questions, to which we responded with supporting data and insights,” Lee says. “We greatly appreciated the client’s upfront communication of their needs, as it enabled us to efficiently allocate responsibilities and determine the appropriate approach for each scenario.” 

Cultivating a culture of CMC excellence

Baek says a collaborative team culture led by leaders like Lee fosters a continuous learning environment where both veteran and early-career scientists consistently exchange questions and expertise, ultimately preparing the entire team to work toward client satisfaction. 

“That is the beauty of Samsung Biologics,” Lee says. “We consistently explore ways to grow, ways to solve problems more expeditiously, and ways to serve our clients better—as a team.” 

Since the launch of its development services, Samsung Biologics has helped clients achieve numerous clinical approvals from the FDA, Health Canada, the European Medicines Agency, and other regulatory authorities. Its track record of client satisfaction stems from a continuous culture of CMC excellence that Samsung Biologics consistently cultivates with and for its clients.

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