CENTRALISING STABILITY STUDIES MANAGING RISKS. Girish Joshi Frankfurt, 24 October, 2017

Transcription

1 CENTRALISING STABILITY STUDIES MANAGING RISKS Girish Joshi Frankfurt, 24 October, 2017

2 AGENDA Recipharm Factors to consider when selecting a contract partner Why centralising? From sample receipt to reporting Mitigating risks 2

3 A LEADING CDMO ON THE GLOBAL ARENA 5,000 We have approximately 5,000 employees 500 More than 500 products in 2,700+ presentations 100 Operating in 100+ markets Public company - listed on Nasdaq Stockholm since 2014 SEK 5.3bn 1 Turnover (EUR 550m) 20+ facilities in Europe, USA and India 3 Note 1. LTM June 2017

4 A COMPREHENSIVE SERVICE OFFERING Development Synthetic chemistry Analytical development Formulation development Clinical supply Bioanalysis Drug delivery technologies Regulatory services Dossier development Manufacturing Procurement of starting materials API manufacturing Pharmaceutical manufacturing Packaging Serialisation Supply chain management 4

5 LOCALLY PRESENT FOR YOUR GLOBAL NEEDS SWEDEN Stockholm Stockholm Höganäs Karlskoga USA Research Triangle Park Solna Strängnäs Uppsala Uppsala EUROPE UK ITALY Ashton Brescia Lainate GERMANY Masate Wasserburg Paderno Dugnano FRANCE PORTUGAL ISRAEL INDIA Fontaine Kaysersberg Odivelas Queluz Ness Ziona Bengaluru Karnal & Paonta Sahib Monts Pessac SPAIN 5 Leganés Parets Manufacturing services Development services

6 MULTIPLE FACTORS TO CONSIDER WHEN SELECTING A CONTRACT PARTNER FOR STABILITY STUDIES Infrastructure Manpower Technical competence Quality 6

7 WHY CENTRALISING? Stability studies play an essential role across the lifecycle of pharmaceutical products Time Stability studies are a routine service that may overload your labs while you need to focus on more valuable activities, i.e. might delay time to market Cost Stability studies are labour intensive and are better located in low labour cost countries Resource intensive Requires infrastructure and technical expertise to manage large stability programs

8 BENGALURU - CENTRE OF EXCELLENCE Recipharm provides a complete stability studies service from its facility in Bengaluru, India Samples are received from global development & manufacturing sites to Recipharm in Bengaluru, India Experience in managing large stability programs for MNC GMP approved facility Since 1987, the facility has been operating to the highest quality standards, while also delivering Eastern cost advantages 75 Our team of more than 75 experienced scientists deliver the necessary technical expertise 8

9 FROM SAMPLE RECEIPT TO REPORTING Compilation of stability report and approval Licensing, gap analysis and protocol prep/review Sample shipment Receipt and integrity check Sample pullout, analysis and review Labelling, stability charging 9

10 SYSTEM COMPLIANCE Management Effective logistic management Project management Dedicated one point of contact Agreement Quality & technical agreement Empower-3 Use of Empower-3 custom-field calculations which saves lot of time and error free data computation Paperless lab Where electronic signoff is practiced for chromatographic, potentiometric and dissolution data. Back-up Electronic data back-up and audit trail review makes the lab compliant with current 21-CFR regulations. e-lims e-lims software is being used for stability data compilation 10

11 THE SERVICE INCLUDES 1 Long-term ICH stability studies 2 Accelerated ICH stability studies, force degradation and photo-stability 3 Shelf-life assessment 4 In-use studies 5 Short-term temperature excursion studies

12 THE SERVICE INCLUDES 6 Restricted access control, stability storage rooms set as per ICH stability conditions 7 Freeze-thaw & temperature cycling 8 Support for schedules II, IIIN, and IV controlled substances 9 State-of-the-art analytical capabilities including microbiology testing 10 Execution of protocol, data analysis and final report

13 MITIGATING RISK Sample shipment Approved shippers Data loggers to monitor temp excursion SOP for Transportation and temp excursion Out of Trend and Specification (OOT & OOS) No 1 priority SOPs Technical expertise on data analyse Redundant compressor Alarm system Redundant compressor for stability chambers and UPS connectivity Alarm system at different level of notification 13

14 FLEXIBLE SOLUTION Flexible solutions to suit all types of customers 1 Fee per sample analysis 2 Fee per hour 3 FTE program 4 Dedicated analytical testing laboratories 14

15 QUALITY TRACK RECORD QUALITY Each year approximately four big pharma audit the facilities EU QP approved FDA inspected in 2012, 2015 and 2017 (no critical or major observations)

16 QUESTIONS?