Applying Quality by Design to the manufacture of drug product for biopharmaceuticals

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00:00:00 Applying Quality by Design to the manufacture of drug product for biopharmaceuticals
00:00:54 Quality by Design in DP development
00:01:04 What is Quality by Design?
00:01:32 Where does QBD start for DP?
00:01:57 Product Knowledge
00:02:31 Before designing your study
00:03:20 Before designing your study (cont.)
00:03:55 Before designing your study (cont.)
00:05:05 Before designing your study (cont.)
00:07:03 Before designing your study (cont.)
00:08:02 Matrix Design Screening
00:09:01 Matrix design example, round 1
00:10:17 Disclaimers on formulation designs
00:10:57 Matrix design example, round 2
00:11:41 Matrix design example, Round 3
00:12:25 Design of Experiments
00:12:55 DOE example, round 1
00:13:37 Why include NTA in preformulation studies?
00:15:46 Why include DSC in pre-formulation studies?
00:17:00 Outcome of Pre-formulation Studies
00:17:52 Know your Process
00:17:57 The Drug Product process
00:18:45 Time out of Refrigeration/ Photosensitivity
00:19:48 Time out of Refrigeration/ Photosensitivity, cont.
00:21:24 Pumping studies
00:23:18 Material Compatibility studies
00:24:05 Analytics for pumping and material compatibility studies
00:25:03 Know your Container/Closures
00:25:08 Compatibility of Primary containers
00:25:15 Compatibility of Primary containers
00:27:51 Compatibility of Primary containers
00:29:33 Compatibility of Primary containers
00:30:35 Compatibility of Primary containers
00:32:30 Analytics for Primary Container studies
00:33:25 Risk Assessments
00:33:28 Risk Assessments
00:34:08 Risk Assessments (cont)
00:35:21 Conclusions
00:36:09 Questions?
00:36:13 Thank you for your attentionAny questions?
00:46:21 Contact Information
QBD 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.