Merck Pre-Conference Workshop
Advances in the manufacturing of Antibody based therapeutics : Key Trends and Developments
Concept
Join Us!
This event brings together industry leaders, process scientists and manufacturing experts to examine the latest trends and developments in the production of antibody‑based therapeutics - including antibody‑drug conjugates (ADCs). Through focused presentations and panel discussions, we will explore technological innovations across the value chain, regulatory and scale-up considerations, accelerating development timelines, and best practices that are driving efficiency in the manufacturing process.
Attendees will gain practical insights with case studies and discussions from users, don’t miss this opportunity to network with leaders in the field and enhance your understanding of the dynamic advancements in antibody-based therapeutics.
Highlights
- Gain valuable insights and explore practical applications through scientific talks.
- Explore cutting-edge solutions at our product demonstrations and exhibition.
- Connect & engage with industry experts and peers to discuss innovative strategies for utilizing Sartorius' solutions.
Sessions
Agenda
In this presentation, we will outline the workflow from monoclonal antibody (mAb) production to antibody-drug conjugate (ADC) development, encompassing both upstream processes and conjugation through to downstream purification. We will provide a concise overview of the Chemistry, Manufacturing, and Controls (CMC) quality control testing throughout the product lifecycle, as facilitated by Merck BioReliance contract testing services. Our solutions will be framed around customer challenges, with a particular focus on optimizing the conjugation process, which serves as a critical bridge between mAb production and ADC purification.
Speakers:
June Hwang, Senior Modality Leader, Advanced Antibodies, Asia Pacific (exclude China), Process Solutions, Merck Life Science
Dr. Huixing Feng, PhD, Sales Development Manager, Asia Pacific (exclude China), Contract Testing Services, Merck Life Science
This session explores how the next-generation CHO cell line based on CHOZN GS cell line was developed — improving productivity, increasing efficiency of cell line development process, and shortening timeline while meeting regulatory compliances. Case studies showcasing the cell line development workflow and the clones' performance in fed-batch and perfusion culture processes will be shared.
Speaker:
Dr. Janice Tan, PhD, Head of Upstream and Process Consultancy, Asia Pacific (exclude China), Process Solutions, Merck Life Science
In line with the progress in bioprocessing and the latest regulatory guidance, next-generation sequenceing (NGS) technology is expected to be increasingly utilized at different stages of CMC to advance the manufacturing of antibody-derived therapeutics. Key applications ranging from clone selection, assurance of genetic stability and viral safety, to assessment of clonality or population homogeneity of the cell substrate, will be discussed.
Speaker:
Dr. Edmund Ang, PhD, Senior Technical Expert, Contract Testing Services, Merck Life Science
- How to approach "closed processing" mode?
- What are the challenges and its solutions?
- The regulatory considerations
- How to apply single-use technologies?
- Best practices for purification process optimization - - how to improve clearance of aggregate species and DAR variants
- Clarification
- TFF
- Chromatography
Esteemed Voices From the Industry
Our selected experts will share insights on the latest trends, challenges, and developments in this dynamic field. Engage in unique discussions, learn about cutting-edge scientific discoveries, and explore the future of biopharmaceuticals with these influential thought leaders.
Dr. Edmund Ang is the Senior Technical Expert Asia Pacific and joined BioReliance® Contract Testing Services, Merck KGaA in 2017. In this role, Edmund provides technical support on CMC testing of biotherapeutics to biopharma developers and manufacturers in Asia Pacific. He has more than 20 years of experience in life science industry with R&D experience in cancer drug and biomarker discovery at Eli Lily and Ionis Pharmaceuticals, as well as commercial technical experience in cellular analysis and bioproduction with Roche Diagnostics, and Life Technologies/Thermo Fisher Scientific.
Dr. Janice Tan heads the upstream, process materials and process consultancy team in Merck Asia Pacific excluding China. She leads a team responsible for providing technical consultation on upstream process development, presenting holistic and innovative upstream solutions to customers. Janice has over 20 years of experience in upstream bioprocessing of biotherapeutics and holds a Ph.D. in Biochemistry from the National University of Singapore.
June Hwang is Senior Novel Modality Leader, Advanced Antibodies at Merck, with over 15 years of experience in the life science and biopharmaceutical industries. Over her 12 years at Merck, she has built deep expertise across downstream and upstream processing, single‑use (SU) systems, and continuous bioprocessing. As Global Go‑To‑Market Lead, she has overseen portfolios including clarification, upstream systems, and mixers, and has driven diverse APAC projects in collaboration with global teams.
She provides customer‑centric technical consulting and bioprocess optimization solutions in monoclonal antibodies and complex antibody technologies. Prior to Merck, she worked at ISU Abxis as a researcher, developing downstream processes for monoclonal antibody biosimilars. She holds an M.S. in Bioengineering from Seoul National University.
Dr. Huixing Feng joined Merck BioReliance® as Technical Expert, providing biologics safety scientific and technical support and advice to biopharma developers and manufacturers in the Asia Pacific region. In her current role as Sales Development Manager for Biosafety testing and Analytical development services, she works closely with the clients on cell bank characterization, QC release testing including bulk harvest, drug substance and drug product, as well as the product characterization and stability program.
