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 |