Workshop

Seongkyu Yoon Workshop

Workshop & courses

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

Current and Upcoming Events

  • 2020 Biomanufacturing Professional Training Series, “Viral Vectors for Gene Therapy-Manufacturing“, (Virtual, March 9-11, 2021). Registration fee for this event is $2,500. Please head over to BlueSnap to complete your registration.
  • 2020 Biomanufacturing Professional Training Series, “Industrial Lyophilization Training“, (Virtual, February 8-10, 2021). Registration fee for this event is $2,500. Please head over to BlueSnap to complete your registration.
  • 2020 Biomanufacturing Professional Training Series, “Industrial Bioprocessing Course“, (Virtual, February 1-March 5, 2021). Registration fee for this event is $3,750. Please head over to BlueSnap to complete your registration.
  • 2020 Biomanufacturing Professional Training Series, “Statistical Quality Control in Manufacturing“, (Virtual, January 11-13,  2020). Registration fee for this event is $2,500. Please head over to BlueSnap to complete your registration.
  • 2020 “Bioprocess Data Analytics and Machine Learning“, (Virtual, October 12-14, 2020). Registration fee for this event is $3,500. Please head over to MIT to complete your registration.

Previous Events

  • 2018 Biomanufacturing Annual Summit, “Biomanufacturing Innovation”, Boston MA, Sep 9-10, 2018
  • 2017 Biomanufacturing Annual Summit, “Beyond monoclonal antibody”, Boston MA, May 22-23, 2017
  • 2016 Biomanufacturing Annual Summit, “Future Biomanufacturing”, Boston MA, May 23-24, 2016
  • 2015 Biopharmaceutical Consortium Annual Summit, “Raw material variability and its process control in Bioprocessing”, Lowell MA, May 18-19, 2015
  • 2014 Biopharmaceutical Consortium Annual Summit, “PAT and QbD in Biopharmaceutical”, Lowell MA, May 29-30, 2014
  • 2013 Biopharmaceutical Consortium Annual Summit, “Continuous Bioprocessing”, Lowell MA, May 15, 2013
  • 2012 Biopharmaceutical Consortium Annual Summit, “Biopharmaceutical Challenges and Innovation”, Lowell MA, Mar. 9, 2012