Evolve Manufacturing Processes by Implementing Disruptive Technologies

The desire for innovative technology that can eventually cause disruptive changes remains high in the biotech pharmaceutical industry. The road between pursuing and developing that technology to genuine implementing is not a smooth ride. In this webinar, the presenter identifies key challenges of implementing innovative technologies and the major drive for implementing innovative technologies and process upgrades. The presenter will share some case studies of implementing successful innovation tools and provide comparative economic analysis based on the understanding the true value of innovation driven process design. The webinar also provide the insight of the balance needs for quality, cost and speed.
Presented by Yuyi Shen, Associate Director and Head of Development & Manufacturing at Bolt Biotherapeutics

Yuyi Shen is the associate director and head of process development & manufacturing at Bolt Biotherapeutics.  She also served different scientific roles in process development and manufacturing science department at various biotech company including XOMA, Bayer, BioMarin and Grifols. She holds a PhD degree in Chemical Engineering from University of California, Davis.
Yuyi provides scientific leadership with a speciality in process improvement, scale up, technical transfer to bioprocess manufacturing in cGMP environment. She is a strong subject matter expert in design robust processes for protein purification with monoclonal antibody, antigen and Viral like Particle etc, ensuring Critical Quality Attributes are achieved. She had solid trouble shooting and problem solving skills and encouraging innovation technology to achieve high efficiency and better quality.
 
Sponsored by Merck

The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has 20,000 employees and 60 manufacturing sites worldwide, with a portfolio of more than 300,000 products enabling scientific discovery. From drug discovery and development to manufacturing and diagnostics, Merck is dedicated to solving the toughest problems in life science by collaborating with the global scientific community. Merck’s products range from lab water systems to gene-editing tools, antibodies, cell lines and end-to-end systems to manufacture drugs. Merck works closely with its customers from academia, biotech and pharma to help deliver the promise of their work better, faster and safer.
Presented by John Cyganowski, Director of Manufacturing Sciences and Technologies Downstream Americas for MilliporeSigma
John Cyganowski is the Director of Manufacturing Sciences and Technologies Downstream Americas for MilliporeSigma, a business of Merck KGaA, Darmstadt, Germany. This is a team of engineering subject matter experts that assist in scale-up, validation, implementation of MilliporeSigma technologies, executing technical work for mid to late stage projects. John has specialized in Tangential Flow Filtration, Aseptic Processing, Viral Clearance and Large Scale Bioprocess Manufacturing over his 25 years with MilliporeSigma. He has served as an instructor for the Tangential Flow Filtration section of the annual ASME Downstream BioProcessing and Economics course and is a member of the Parenteral Drug Association. He is a member, American Chemical Society, BIOT Division. He has served as co-Chair of Non-Chromatographic Separations Section, and as Co-Chair of Downstream Processes: Technology Transfer, Scale-up and Scale-Down for the 2015 & 2016 ACS Annual Conventions. John holds a Bachelor of Science Degree in Chemical Engineering from Northeastern University.