CENTRALISING STABILITY STUDIES – MANAGING RISKSGirish JoshiFrankfurt, 24 October, 2017

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AGENDA

• Recipharm

• Factors to consider when selecting a contract partner

• Why centralising?

• From sample receipt to reporting

• Mitigating risks

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5,000We have approximately

5,000 employees

SEK 5.3bn1

Turnover (EUR 550m)

500More than 500 products in 2,700+ presentations

100Operating in 100+

markets

Public company -listed on Nasdaq Stockholm since 2014

20+ facilities in Europe, USA and

India

Note 1. LTM June 2017

A LEADING CDMO ON THE GLOBAL ARENA

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A COMPREHENSIVE SERVICE OFFERING

Development

• Procurement of starting materials

• API manufacturing

• Pharmaceutical manufacturing

• Packaging

• Serialisation

• Supply chain management

Manufacturing

• Synthetic chemistry

• Analytical development

• Formulation development

• Clinical supply

• Bioanalysis

• Drug delivery technologies

• Regulatory services

• Dossier development

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ITALY

Brescia

Lainate

Masate

Paderno Dugnano

PORTUGAL

Odivelas

Queluz

SPAIN

Leganés

Parets

LOCALLY PRESENT FOR YOUR GLOBAL NEEDS

USA

Research Triangle Park

SWEDEN

Stockholm

Stockholm

Höganäs

Karlskoga

Solna

Strängnäs

Uppsala

Uppsala

EUROPE

UK

Ashton

GERMANY

Wasserburg

FRANCE

Fontaine

Kaysersberg

Monts

Pessac

ISRAEL

Ness Ziona

INDIA

BengaluruKarnal & Paonta Sahib

Manufacturing services Development services

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MULTIPLE FACTORS TO CONSIDER WHEN SELECTING A CONTRACT PARTNER FOR STABILITY STUDIES

Infrastructure Manpower

QualityTechnical competence

WHY CENTRALISING?

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

Stability studies play an essential role across the lifecycle of pharmaceutical products

Time

Stability studies are labour intensive and are better located in low labour cost countriesCost

Requires infrastructure and technical expertise to manage large stability programs

Resourceintensive

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75

Recipharm provides a complete stability studies service from its facility in

Bengaluru, India

Our team of more than 75 experienced scientists deliver

the necessary technical expertise

GMP approved facility

Since 1987, the facility has been operating to the highest quality standards, while also delivering

Eastern cost advantages

BENGALURU - CENTRE OF EXCELLENCE

Samples are received from global development & manufacturing sites to Recipharm in Bengaluru, India

Experience in managing large stability programs for MNC

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FROM SAMPLE RECEIPT TO REPORTING

Licensing, gap analysis and protocol prep/review

Sample shipment

Receipt and integrity check

Labelling, stability charging

Sample pull-out, analysis and review

Compilation of stability report and approval

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SYSTEM COMPLIANCE

Back-up

Electronic data back-up and audit trail review

makes the lab compliant with current 21-CFR

regulations.

Quality & technical agreement

Effective logistic management

Project management – Dedicated one point of contact

AgreementManagement

Where electronic sign-off is practiced for chromatographic, potentiometric and dissolution data.

“Paperless lab”

Use of Empower-3 custom-field calculations which saves lot of time

and error free data computation

Empower-3

e-LIMS software is being used for stability

data compilation

e-LIMS

THE SERVICE INCLUDES

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Long-term ICH stability studies

Accelerated ICH stability studies, force degradation and photo-stability

Shelf-life assessment

In-use studies

Short-term temperature excursion studies

THE SERVICE INCLUDES

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Freeze-thaw & temperature cycling

Support for schedules II, IIIN, and IV controlled substances

State-of-the-art analytical capabilities including microbiology testing

Execution of protocol, data analysis and final report

Restricted access control, stability storage rooms set as per ICH stability conditions

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MITIGATING RISK

Alarm system

Alarm system at different level of notification

• No 1 priority• SOPs • Technical expertise

on data analyse

• Approved shippers• Data loggers to monitor

temp excursion • SOP for Transportation

and temp excursion

Out of Trend and Specification (OOT & OOS)

Sample shipment

Redundant compressor for stability chambers and UPS connectivity

Redundant compressor

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FLEXIBLE SOLUTION

Flexible solutions to suit all types of customers

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Fee per sample analysis

Fee per hour

FTE program

4Dedicated analytical testing laboratories

• Each year approximately four big pharma audit the facilities

• EU QP approved

• FDA inspected in 2012, 2015 and 2017 (no critical or major observations)

QUALITY

QUALITY TRACK RECORD

QUESTIONS?