Integrated Continuous Biomanufacturing
May 18-20, 2016
| ICB Day 1
| Description
| Type
| Instructor
|
| 8:00
| Introduction
| Lecture
| Prof. Seongkyu Yoon, UML
|
| 8:10
| M1: Bioprocess General
| Lecture
| Prof. Carl Lawton, UML
|
| 10:00
| M2: USP Technology & Practices
| Lecture
| Dr. Sadettin Ozturk, MassBiologics
|
| 12:00
| Lunch
| ||
| 1:00
| M3: DSP Technology & Practices
| Lecture
| Dr. Aaron Noyes, Pfizer
|
| 3:00
| M4: Case Study 1, BioVolutions
| Lecture
| Dr. Maurizio Cattaneo, BioVolutions Inc.
|
| ICB Day 2
| Description
| Type
| Instructor
|
| 8:00
| M5: Case Study 2, Genzyme
| Lecture
| Dr. Shawn Barrett, Genzyme
|
| 10:00
| M6: ATP Technology and Application
| Lecture
| Christine Gebski, Repligen |
| 12:00
| Lunch
| ||
| 1:00
| M7: Commercial Technology - SMB & PCC
| Lecture
| Dr. Kathleen Mihlbachler, LEWA Nikkiso Group |
| 3:00
| M8a: Continuous Cell Culture Technology M8b: Continuous DSP Development and Modeling
| Lecture
| Mark Henry Kamga, UML Ketki Behere, UML
|
| ICB Day 3
| Description
| Type
| Instructor |
| 8:00
| Lecture
| Dr. Prokash Paul, UML Prof. Seongkyu Yoon, UML
| |
| 10:00
| M10: Systems Technology | Lecture
| Dr. Shaun Galbraith
|
QbD Risk Assessment and DS Implementation:
May 18-20, 2016
Instructed by: Dr. Sun Kim, QbD Works LLC & Prof. Seongkyu Yoon, UML
| QbD RA & DSI Day 1
| Description
| Type
| Instructor
|
| 8:00
| Introduction
| Lecture | |
8:10 | M1: QbD Risk Assessment Introduction
| Lecture | Dr. Sun Kim, QbD Works LLC
|
| 9:00
| M2: QbD/DS Implementation Introduction
| Lecture | Prof. Seongkyu Yoon, UML
|
| 10:00
| M3: QbD RA Tool Introduction
| Lecture | Dr. Sun Kim, QbD Works LLC |
| 11:00
| M4: QbD/DS Tool Introduction
| Lecture
| Prof. Seongkyu Yoon, UML |
| 12:00
| Lunch
| Lecture | |
| 1:00
| M5: QbD 1st Steps I
| Lecture | Dr. Sun Kim, QbD Works LLC |
| 2:00
| M6: QbD 1st Steps II
| Lecture | Dr. Sun Kim, QbD Works LLC |
| 3:00
| M7: Lean QbD I
| Lecture | Dr. Sun Kim, QbD Works LLC |
| 4:00
| M8: Lean QbD II
| Lecture | Dr. Sun Kim, QbD Works LLC |
| QbD RA & DSI Day 2
| Description
| Type
| Instructor
|
| 8:00
| M9: Case Study I
| Lecture
| Dr. Sun Kim, QbD Works LLC |
| 9:00
| M10: Case Study II | Lecture | Dr. Sun Kim, QbD Works LLC |
| 10:00
| M11: Case Study III
| Lecture | Dr. Sun Kim, QbD Works LLC |
| 11:00
| M12: Case Study IV
| Lecture | Dr. Sun Kim, QbD Works LLC |
| 12:00
| Lunch
| ||
| 1:00
| M13: Design Space Concepts
| Lecture | Prof. Seongkyu Yoon, UML |
| 2:00
| M14: Design Space Building
| Lecture | Prof. Seongkyu Yoon, UML |
| 3:00
| M15: Design Space Case Study I
| Lecture | Prof. Seongkyu Yoon, UML |
| 4:00
| M16: Design Space Case Study II
| Lecture | Prof. Seongkyu Yoon, UML |
| QbD RA & DSI Day 3
| Description
| Type
| Instructor
|
| 8:00
| M17: Process Optimization
| Lecture | Prof. Seongkyu Yoon, UML |
| 9:00
| M18: Set-point Analysis
| Lecture | Prof. Seongkyu Yoon, UML |
| 10:00
| M19: CQA Spec Setting
| Lecture | Prof. Seongkyu Yoon, UML |
| 11:00
| M20: Design Space Challenges
| Lecture | Prof. Seongkyu Yoon, UML |
May 25-27, 2016
Instructed by: Chris McCready, M.Eng., MKS Data Analytics Solutions & Prof. Seongkyu Yoon, UML
| PAT/QbD Day 1
| Description
| Type
| Instructor
|
| 8:00
| MVDA Introduction
| Lecture
| Chris McCready, M.Eng., MKS Data Analytics Solutions
|
| 9:00
| Principal Component Analysis & Application
| Lecture/Tutorial
| Chris McCready, M.Eng., MKS Data Analytics Solutions |
| 10:00
| Partial Least Squares, Review
| Lecture | Chris McCready, M.Eng., MKS Data Analytics Solutions |
| 11:00
| Tutorial on Partial Least Squares
| Tutorial
| Chris McCready, M.Eng., MKS Data Analytics Solutions |
| 12:00
| Lunch
| ||
| 1:00
| Batch Modeling Introduction
| Lecture
| Chris McCready, M.Eng., MKS Data Analytics Solutions / Prof. Seongkyu Yoon, UML
|
| 2:00
| Batch Modeling Application
| Lecture
| Chris McCready, M.Eng., MKS Data Analytics Solutions / Prof. Seongkyu Yoon, UML |
| 3:00
| Batch Evolution Modeling I & Tutorial | Lecture / Tutorial | Chris McCready, M.Eng., MKS Data Analytics Solutions / Prof. Seongkyu Yoon, UML |
| 4:00
| Batch Evolution Modeling II & Tutorial | Lecture / Tutorial | Chris McCready, M.Eng., MKS Data Analytics Solutions / Prof. Seongkyu Yoon, UML |