Newsletter | July 2024 Recap

Navigating biopharmaceutical complexity: embracing quality-by-design for enhanced development strategies

The implementation of a Quality-by-Design (QbD) approach enables drug developers to construct more robust processes and analytical methods, resulting in high-quality pharmaceuticals. This whitepaper explores how we thoroughly manage sources of variability inherent in the process and mitigate risks to support streamlined and standardized production. Read more

Building a path to approval with effective regulatory support

Given the complex and ever-changing regulatory landscape, partnering with an experienced CDMO is essential to accelerate candidate progression and approval. In this whitepaper, we explain how we leverage our regulatory filing expertise and make continuous efforts to advance clients' products to the market. Read more

Navigating biologics chemistry, manufacturing and controls with an innovative CDMO

Establishing an effective chemistry, manufacturing, and control (CMC) strategy is critical to ensure the safety and quality of drug products. In this article, our analytical scientists discuss how we develop tailored strategies to support the development of next-generation biologics.?Read more

Create therapies confidently with quality by design

As innovative treatments require stringent quality control measures, drug manufacturers are increasingly embracing Quality by Design (QbD) as a pivotal strategy. In this article, Songyoung Kim, Director of CDO Downstream and Development, discusses how QbD effectively addresses potential variability and risks, thereby optimizing processes and ensuring successful development outcomes.?Read more

Antibody-drug conjugate (ADC) facility

Our dedicated, standalone antibody-drug conjugates (ADC) facility is on track for completion within this year. Located across from both Bio Campus I and II, the facility will enable us to offer seamless services from development to manufacturing for your ADC project. Learn more

BIOPLUS?INTERPHEX KOREA 2024 Highlights

Samsung Biologics shared major business updates and plans for expanding its ADC and mRNA capabilities at the BIOPLUS?INTERPHEX KOREA, which attracted over 250 companies and 10,000 industry experts. Heonchang Lim, Director of Formulation Development, presented on the company's advanced developability assessment tool, DEVELOPICK?, explaining how this technology facilitates efficient formulation development and enhances the company's ability to deliver high-quality biopharmaceutical solutions. Learn more

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