Seongkyu Yoon

Our group’s mission is to accelerate biopharmaceutical manufacturing innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. We also focus our efforts on driving down the costs and risks associated with manufacturing biologics including proteins, cell based therapeutics and vectored gene therapies. 

Affliated Websites                   

Quality by Design (QbD) and Process Analytical Technology

(PAT) for Biopharmaceuticals
Concepts and Applications in Development and Commercialization

Boston, Massachusetts

Course Description:

• This course aims to clarify the key concepts that interplay in defining and implementing QbD and PAT towards development and manufacturing of biotech products. This will be achieved via a sequence of lectures and group work. Concepts discussed include: Critical Quality Attributes (CQA), Design Space, Risk Assessment, Process Characterization, Process Analytical Technology, Scale-up, and Technology Transfer. At the end of the course, the audience will be able to explain what these concepts mean, the role they play in QbD/PAT implementation and the interplays amongst them.

Instructors: Anurag Rathore (IIT, India), Seongkyu Yoon (UMass Lowell) 

Date & Location:

  • Date: Monday May 6 – Tuesday, May 7, 2024 from 9 a.m. – 5:30 p.m.
  • Location: University of Massachusetts Club (1 Beacon Street #32nd floor Boston, MA 02108)

TARGET AUDIENCE:

  • Scientist, Senior Research Scientist, Bioprocess Engineer, or equivalent, involved in product and process development, regulatory, quality assurance/control, and manufacturing of biotech therapeutics.

  • Attendees from academia and regulatory agencies may also benefit depending on their areas of interest and level of experience.

    COURSE OBJECTIVES:

  • Define CQAs and explain the link between CQAs and Design Space

  • Understand what needs to be done differently in your current job in the QbD paradigm

  • Understand the role of PAT in QbD paradigm and the challenges of implementing QbD for the commercialization of biotech products

  • Explain the role of Risk Assessment and where to go to find the appropriate tool

     

    Registration:

    • Register using the QR code

    • Cost of attendance:

      o $1800 for Industry
      o $1,440 for academia/government employees o $180 for students

    • For questions please email: bpqc@uml.edu or Maurizio_Cattaneo@uml.edu.

Profession Training series:
Industrial Bioprocessing Training 2024

Lowell, Massachusetts

Course Description:

• This course teaches key principles and concepts of industrial bioprocessing of protein, cell/gene, and mRNA therapies. The course covers recent technologies and practices of upstream, downstream, and analytical tools in the bioprocessing industry. In addition, FDA initiatives of PAT (Process Analytical Technology), Quality by Design, and Emerging Technology will be covered. This course is an excellent opportunity for biomanufacturing training and workforce development for both new and veteran workers in bio-tech.

Instructors:

• Industry professionals from FDA, BMS, Pfizer, MilliporeSigma, UMass Biologics and UMass Lowell. 

Date & Location:

  • Date: Monday July 29 – Friday, August 2, 2024, from 8:30 a.m. – 5 p.m

  • Location: UMass Lowell North Campus, Lowell, Massachusetts, U.S.A , Pulichino Tong Business Center, #120

TARGET AUDIENCE:

  • Scientist, Senior Research Scientist, Bioprocess Engineer, or equivalent in Pharmaceuticals, Biopharmaceuticals.

  • Attendees from academia and regulatory agencies may also benefit depending on their areas of interest and level of experience.

    COURSE OBJECTIVES:

  • At the completion of this course, the participant will be able to:

  • Understand the recent technologies of upstream, downstream, and analytical tools used in the bioprocessing industry.

  • Explore advantages, disadvantages, and various applications in actively emerging cell and gene therapies along with their bioprocessing practices.

  • LearnQualitybyDesign(QBD)inregulatoryandbig

    data analytics used in the biopharmaceutical

    development and manufacturing field.

Registration:

• For questions please email: bpqc@uml.edu or Maurizio_Cattaneo@uml.edu

Recent News

  • February 2024: Congratulations Yongdan and Qiang along with co-authors, Soyoung Park, Seo-young Park, Yong Suk Lee, and Dr. Dongyup Lee. The review paper was accepted for publication in the Journal of Biotechnology Advances with the title of Decoding Cellular Mechanism of Recombinant Adeno-associated Virus (rAAV) and Engineering Host-Cell Factories toward Intensified Viral Vector Manufacturing. This review paper proposes a control strategy from the perspectives of host cell and materials (e.g., AAV plasmids) based on the characterization of molecular features and our existing knowledge of the AAV viral life cycle, rAAV and other viral vector productions in the human embryonic kidney (HEK) cells.

 

  • January 2024: Welcome Dr. Younyoung Choi, post-doctoral fellow and Dr. Tom Bertalan, research engineer to the group. They will lead digital twin and upstream biotherapeutics development projects. 

 

  • January 2024: Welcome Zahra (started in the Spring Semester 2024 in Pharmaceutical Sciences program) and Kanika (started in the Fall semester 2023 as a PhD student in BMEBT program) as new PhD students. 

 

  • January 2024: Haenah Kim and Hung Tran are doing PhD student industrial experiences at Takeda Pharmaceutical. The fellowship will be done over 6 months. This is NSF funded industrial experience program.  

 

  • January 2024: Richard Marx awarded KFF fellowship ($12K). This is a prestigious award to be given to PhD student who has successfully defended a research proposal. 

 

  • January 2024: Congratulation Richard on the publication. The manuscript was accepted for publication in the Biotechnology Journal with the title of CFD evaluation of hydrophobic feedstock bench-scale fermenters for efficient high agitation volumetric mass transfer. This research paper is based on a NSF-funded project led by Prof Dongming Xie.