I just spoke at KOBIA’s 2014 QbD Workshop. Thanks to my dear friend, Prof. Yoon at Univ. of Mass at Amherst, (who also invited me to BPQC 2014). The QbD workshop had a good turnout of 120 representatives from Korean Biopharmaceutical companies.
The sessions included 4 sessions, ending with a Panel Q&A:
- Quality by Design: Current Status – (Dr. KH Jung of KBIO’s Clinical Drug Manufacturing Center)
- A-VAX: Control Strategy Section – (Dr. HS Kim of Green Cross’ Central Research Center R&D QA/QC)
- Robust Optimization: Design space exploration and examination – (Dr. SK Yoon of UMass Lowell)
- First Step in QbD – How to get it Right – (Dr. Sun Kim of QbDWorks)
Before sharing the presentations, this is a short update on:
Current Status of QbD in Korea
I began with a question to understand the current status of QbD in Korean BioPharmaceutical companies.
Sun: “Who is implementing QbD?
Please raise your hand if you are implementing QbD.”
Audience: (I took a photo of the response.)
How many raised hands do you see?
Ok, here’s a cultural background information. East Asians (myself included) tend to shy away from raising hands or asking questions. So at first glance, it seemed like no one was implementing QbD. After talking with the participants, did I find out that some companies have applied QbD and most were planning to begin a QbD program.
The global QbD race is on. I am grateful to be part of a historical moment in our industry.
The workshop began with a good news delivered by Dr. Shin of MFDS (FDA of Korea).
QbD Strategy from Ministry of Food Drug and Safety (FDA of Korea)
Dr. Shin of Ministry of Food Drug and Safety shared that the agency is currently drafting a QbD guideline (similar to ICH Q8).
QbD in Korea will not be mandatory but highly encouraged. So not much difference here. FDA’s position is the same: Not “mandatory” but reviewers will look for QbD elements in submissions. So you get the idea — QbD has become the new standard.
In 2014, MFDS has been focusing on QbD education. In 2015, they will develop QbD frameworks and case studies for both small and large molecules. This is similar to FDA’s efforts on QbD pilot programs and published case studies.
MFDS is reaching out to industry to co-develop a practical model. Companies who wants to co-develop a QbD case study may apply. Please contact me if you are interested.