Samsung Biologics bolsters leadership with global biopharmaceutical gurus

SOUTH KOREA — In a strategic move to fortify its position as a leading global contract development and manufacturing organization (CDMO), Samsung Biologics has ushered in two accomplished biopharmaceutical experts, orchestrating a symphony of quality management and regulatory prowess.

Gail Ward, a distinguished pharmaceutical veteran with an impressive four-decade journey, assumes the mantle of Executive Vice President and Head of the Quality Center.

Ward, a U.S. citizen, brings a wealth of quality experience spanning diverse pharmaceutical landscapes, from industry titans to entrepreneurial biotech ventures.

She has etched her expertise in prominent positions including ProKidney Corporation, Celltrion, Diosynth RTP, Lederle-Praxis Biologics, and Biogen.

Lee So-jeong, appointed as Vice President and Head of Regulatory Affairs, commands a vital role in shaping Samsung Biologics’ interactions with global regulatory agencies.

Her prior engagement as Regulatory Affairs Director at GlaxoSmithKline (GSK) in Korea attests to her deep regulatory insight and navigational finesse.

A strategic leap towards excellence

“We plan to focus on enhancing the quality and competitiveness of biopharmaceuticals based on the expertise and know-how from Gail Ward and Lee So-jeong,” asserts Samsung Biologics, outlining their transformative vision.

Established merely a dozen years ago, Samsung Biologics embarked on a trajectory of exponential growth.

Starting with six 5k-liter reactors, their expansion was swift to meet surging demand. The addition of ten 15K-liter reactors marked a significant milestone, followed by the construction of a third plant featuring twelve more reactors.

Now, a fourth plant looms, a colossal US$2 billion “Super Plant” that will eclipse the combined expanse of the three existing facilities.

Unveiling novel avenues

With the recent investment surge, Samsung Biologics casts its gaze on contract manufacturing for vaccines, cell and gene therapies.

Simultaneously, their biosimilars division marches forward, bolstering its pipeline. This holistic approach aims to galvanize the local bio-cluster by nurturing talent, fortifying the supply chain, and extending technical support to emerging biotechs.

Monoclonal antibodies stand as the focal point of Samsung Biologics’ present pursuits, underpinning their role as a CDMO provider.

The organization has made noteworthy strides, including the commencement of an ADC conjugation facility that underpins the future of therapeutic advancements.

Alongside this, their expertise extends to manufacturing RNA-based vaccines and other mRNA-based drug substances.

Embracing an ambitious vision, Samsung Biologics champions cell and gene therapy through the Samsung Life Science Fund, a collaborative endeavor with Samsung C&T.

Through strategic investments in entities like Jaguar Gene Therapy, Senda Biosciences, and Araris Biotech AG, they are weaving the fabric of a transformative tomorrow.

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