날짜 기록: April 19 2016
Duration: 47 minutes 22 secondsQBD is a term that is often spoken with respect to the production of biopharmaceuticals. However, despite the issuance of guidance documents on this topic, it is still relatively poorly understood.
This discussion seeks to demystify the concept of quality by design as it applies to fill/finish of drug product. This serves also as a reminder that not all drug products are the same in the world of biotherapeutics.
Critical Quality Attributes are dependent not just on the chemical and basic biophysical properties of the product, but also on higher order structural elements. The right instruments must be applied at all stages of drug product development to minimize the probability of unwanted visible and subvisible particles in product that will ultimately be injected into patients. These stages include formulation development, selection of primary containers for drug product, and the evaluation of drug product filling equipment option (pumping studies).
The combination of orthogonal methods, such as Nanoparticle Tracking Analysis (Nanosight) in conjunction with Resonant Mass Measurement (Archimedes) provides an opportunity to both enumerate and understand the structure and types of subvisible particles present in drug product solution that may be formed during the different stages of production. This knowledge enables the development of an effective control strategy to support patient safety.
Table of contents
1. Applying Quality by Design to the manufacture of drug product for biopharmaceuticals
2. Quality by Design in DP development
3. What is Quality by Design?
4. Where does QBD start for DP?
5. Product Knowledge
6. Before designing your study
7. Before designing your study (cont.)
8. Before designing your study (cont.)
9. Before designing your study (cont.)
10. Before designing your study (cont.)
11. Matrix Design Screening
12. Matrix design example, round 1
13. Disclaimers on formulation designs
14. Matrix design example, round 2
15. Matrix design example, Round 3
16. Design of Experiments
17. DOE example, round 1
18. Why include NTA in preformulation studies?
19. Why include DSC in pre-formulation studies?
20. Outcome of Pre-formulation Studies
21. Know your Process
22. The Drug Product process
23. Time out of Refrigeration/ Photosensitivity
24. Time out of Refrigeration/ Photosensitivity, cont.
25. Pumping studies
26. Material Compatibility studies
27. Analytics for pumping and material compatibility studies
28. Know your Container/Closures
29. Compatibility of Primary containers
30. Compatibility of Primary containers
31. Compatibility of Primary containers
32. Compatibility of Primary containers
33. Compatibility of Primary containers
34. Analytics for Primary Container studies
35. Risk Assessments
36. Risk Assessments
37. Risk Assessments (cont)
40. Thank you for your attentionAny questions?
41. Contact Information