E. De Maesschalck Head e-Analytics UCB BioPharma sprl Business Cases implementated through Labware LIMS Labware CEC June 2014 2 Topics • Quick Presentation of UCB BioPharma sprl • Two business cases implemented through standard functionalities in LIMS 1) Facilitating Tool for the preparation of APQR (Annual Product Quality Report) 2) Managing Samples and data in a BioPilot Plant without MES in place. Part I UCB A patient-centric biopharma leader Company Overview March 2014 UCB: A patient-centric biopharma leader Focusing on severe diseases in Immunology and the Central Nervous System Key facts and figures: ■ FY 2013 revenue: € 3 411 million ■ More than 8 500 employees globally ■ Operations in close to 40 countries ■ R&D Spend: ~25% of revenue 4 5 Main core medicines for patients with severe diseases Auto Immune diseases Epilepsy Parkinson’s disease Epilepsy adjunctive Therapy 6 Geographic Presence ( main sites) Developping in the emerging markets and Japan 7 Providing solutions beyond novel medicines with patients Patient summits Patient Advocate programmes Patient and caregiver scholarship programmes Daily support to patients Online support through online communities and educational websites Product design & ehealth Employee support of local patient initiatives Computerized Systems MAP for Analytical Data 8 Facilitating Tool for APQR preparation through LIMS and NWA 10 Annual Product Quality Report APQRs mut be generated each year and provided to authorities. The purpose of these reports is to demonstrate that the company has control on the manufacturing activities for the reported product. Content: ■ Lists of batches ■ List of deviations, OOS, OOC and explanations ■ Details on specifications (regional reporting !!) ■ Process changes ■ Tables of data including summary statistics ■ Charts (individual values, histograms, etc) ■ Some blabla around data. Where the APQR Facilitating tool Can help 11 The Requirements from QA Cut & Paste in Word Selection of Product Selection of Time Period Compara tive Tables Selection of Analyses Summary statistics Charts Edit report Selection of Item Code Selection of Region APQR Facilitating Tool (Use of M0416 - Visual Workflow Enhancements) Starting the Visual Workflow Select existing Create New Cacl statistics Comparison of Periods Export to Excel Edit Batch List 12 (Use of M0416 - Visual Workflow Enhancements) Starting the Visual Workflow Select existing Create New Calc statistics Comparison of Periods Export to Excel Edit Batch List 14 15 After extraction of data: Calc statistics 18 And So the Comparative table is generated 19 Extracting the complete report to Excell 20 Editing the list of batches (remove/insert) 21 Configuring how stats are calculated 22 Configuring decimals and Chart Templates 23 In Summary This tool is fullfilling all requirements (can also be used for other purposes) Speeds up the preparation of the final APQR by cuting / pasting prepared items Allows recovering previous data reports and it generates easily comparison tables Designing a flexible solution for the Bio Pilot Plant (No MES in place) 25 UpStream sampling and analysis requirements DownStream sampling and analysis requirements 26 27 Transformation of the requirement into a « specification like » structure 28 The Key User and Manager View and Workflow 29 Launching a new Production Batch 30 The Operator View and Workflow 31 The Analyst View and Workflow 32 In summary Solution fitting the needs. Visual Workflows. Flexibility through GxP quality process (300 samples per batch, 1000 analytical results) Traceability of samples, including Collection Step. Check of Storage conditions versus Samples Storage requirement ensured. Real Time view of what is going on even from UK. What’s next: see next slide………. 33 Improving the complete process through Voice or Movement Recognition? Brainstorming meetings already occurred (UCB Business, UCB IT and Labware) 34 Thanks to Jonathan Ayimambenwe Bin Wang Marina Gueritee