QUALITY by Design (QBD), Biopharmaceutical Manufacture
- Type: Conference Presentation
- Conference Type:
AIChE Annual Meeting
- Presentation Date:
October 17, 2011
- Skill Level:
You will be able to download and print a certificate for PDH credits once the content has been viewed. If you have already viewed this content, please click here to login.
In the biopharmaceutical industry, consistently manufacturing a safe and high quality protein drug substance can be challenging. Recently, a regulatory structure supporting Quality by Design (QbD) for pharmaceuticals and biopharmaceuticals has been described in International Conference on Harmonization (ICH) Quality documents (Q8 through Q10; available at www.ich.org). Many of the concepts espoused in these ICH documents (e.g. quality target product profile [QTPP], risk-based approaches, product and process understanding, design spaces, control strategies with process analytical technologies [PAT], product life cycle, continuous process verification) are universal for pharma/biopharma manufacturing and can readily be applied to bulk protein production.