Big Data to Design Quality

Transcription

1 Big Data to Design Quality Practical approach in Pharmaceutical Industry Apr 2013 FORTIER Jean-Etienne KM Specialist VERMYLEN Valérie Director KM RULIER Eric - Senior Project Leader Lab Systems JONE Carl - HD of Analytical Dev Bio BERNARD Alain - VP Gov Prioritization Scientific Liaison Congrès BIG DATA PARIS, édition avril 2013 Véronica, living with epilepsy

2 Plan What is Quality by design? SPDM Project Problem Statement Project Methodology Team and roles Project data sources Data model structure Gain on process / product knowledge Project future in UCB 2

3 What is Quality by Design? Quality by Design means : Designing and developing manufacturing Processes during the product development stage to consistently ensure a predefined quality at the end of the manufacturing process. Quality cannot be tested on products but should be built-in from its design according to a predefined quality profile. FDA, Pharmaceutical Quality for the 21st Century A Risk-Based Approach,

4 What is Quality by Design? QbD steps, as followed at UCB Clinical Research Technical Operation Development Risk Mngt expert Regulatory Affairs Quality Assurance Technical Operation Manufacturing / CMO Mngt 4

5 Who? Quality by Design deployment at UCB How? Automation PAT High Res Control Technologic Data Mngnt Team Statistics Organization QbD Training and skills What? Roles and Resp. Sciences Sharing Methodology Scope / MDM Workshop Why? 5

6 Problem Statement We can significantly improve our quality system by confront variability of our process to patients biological information. Does process parameters, product or material quality profile settings able to satisfy UCB patient needs Can we correlate drug efficacy, adverse event rise with quality or process change Cell / RawMat API Product Patient 6

7 Project Methodology Question Answer Scope defintion Analytics need definition Process Steps / "universe" link Parameters definition Data Identification Process Structure Model Data analysis and user training 7

8 Team roles Technical Laboratory scientist Team Leader CMO Managers Clinical Knowledge Management Sponsorship Project Manager Data Scientist Information technology Solution experts Data architects Supply managers Statistician Databases experts Program responsible Clinician 8

9 Project data sources Process as defined in the project Cell thaw Upstream Process Cell expansion Bioreaction Downstream Process Drug product Clinical Kit Patient Purification Filling vial Shipment / pooling Clin. obs External company 9

10 Project data sources Current Status: Disparity of data source and format Cell thaw Upstream Process Cell expansion Bioreaction Downstream Process Drug product Clinical Kit Patient Purification Filling vial Shipment / pooling Clin. obs 10

11 Project data sources 4 Sources format 500 More than 100 parameters batches 3 SCALES 35 Sources tables PILOT 3 Manuf. sites Data 11

12 Data model Structure Sources Site B - Pilot Site B - Large Unstructured data Site A - Lab Site A - Clinical Site A - Large Data Unstructured data Semi-structured data Table Doc Electronic manual capture Structured data Oracle Table import Table views E.T.L Traceability interpretation Single measurement Time related measurement Stability measurement Analytics system Cross-step Multi-format Multi-domain Throughout year historian 12

13 Gain on process / product knowledge Analysis and correlation across steps, organization or geographic site Analysis and correlation from disparate business domain (and datasource) Cross-step Multi-domain Multi-format Throughout year historian Work with disparate format of sources First step in massive data capture and perpetuation. Detection of minor process effect change on product quality. Cyclic variation detected earlier. 13

14 Project future in UCB Parameters per process more Databases connected (SAP, Historian, etc.) More than batches 30 Manuf. sites less Part of unstructured data as Excel More than Real time analyzers Data 14

15 Project future in UCB 15

16 Project future in UCB UCB Pharma, S.A, All rights reserved 16

17 Questions? 17