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ACQUISITION OF A CMO FACILITY-
FROM PURCHASING TO GMP
OPERATIONS IN 1 YEAR

Cristina Velasco
Head of Industrial Processes
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ROVI Group
Leading Spanish
Specialty
Pharma Company

2016 Revenue: €208 Mn

2016 Operating revenues: €265Mn

World Class
Robust
Pre-filled Syringe and
Oral Forms
Research and
Toll Manufacturing Development
and Broad Pipeline
2015 Revenue: €57 Mn

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ROVI GROUP: 4 INDUSTRIAL PLANTS IN SPAIN

3
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ALL STARTED IN MADRID SITE…

INJECTABLE FORMS PRODUCTION SITE

Located in Madrid

Industrial area immersed in the city.

No space to grow

Looking for extra capacity for: 3rd

parties and own pipelines

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San Sebastián de los Reyes
Rovi acquired J+J site in
AS A RESULT…
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REASONS FOR THE CHOICE

OFFERS
TECHNOLOGY THAT
COMPLEMENTS THE
TECH. IN MADRID
SITE

CURRENTLY
2 PRODUCT LINES
OPERATING –
BUT WITH A
IT IS NEARBY MADRID’s GREAT POTENCIAL
SITE, ONLY 20’ DRIVE TO GROW

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STARTING POINT: DUE DILLIGENCE

Due Diligence is a key element to take a decision, to

initiate the process and define the strategy
Evaluate the
facility
Agree on how to
solve the open
deficiencies found

informed decision
making

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AFTER DUE DILLIGENCE

Site to be acquired with

personnel, equipment and
transfer for current products

Decision to Site to be acquired with personnel

acquire and equipment but no transfer

Site to be acquired with

equipment, no personnel, no
transfer

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CHALLENGES & STRATEGY

Start up a site from complete

shutdown to GMP Certified
Operations in one year

♦ Rovi products to be the first to transfer and

REGULATORY register
STRATEGY ♦ To cut down the decision time for clients

♦ All operations were shut down, & certification

OPERATIONS lost
STRATEGY ♦ KEY: We kept services running: PW + HVAC

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EMBRACING CHANGE

Mono Product Dedicated

Site
>> Multi Product Dedicated
Site
Dipensing
Only Filling
Compounding

Two Filling Lines (Vials&syringes) Two Lines

One Format Different Formats

One Packaging Line Two Packaging Lines

One Format Different Formats For Vials&Syringes

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HANDS ON

Revamping
Revamping SYRINGES
SUPPLIES
SUPPLIES
ofof LINE
Production areas ADAPTATION
Production areas

QUALITY
QUALITY &
SYSTEMS
SYSTEMS &
GMP
GMP
CERTIFICATION
CERTIFICATION
VIALS LINE SITE
ADAPTATION
VIALS LINE SITE
ADAPTATION GOVERNANCE
GOVERNANCE

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PROJECT TECH
TRANSFER

ORGANIZATION
TEAM FOR
SYRINGES

QUALITY
TEAM:
REVAMPING &
LEGALIZATION QUALITY
SYSTEMS &
GMP CERT

STEERING
COMMITEE

SITE
SUPPLIES GOVERANCE

TECH
TRANSFER
TEAM FOR
VIALS
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TARGET: GMP CERTIFICATION

Jul 2016
Mar 2016 inspection
qualification ready-
Jan 2016 activities process
revamping finishing validation
works for one
Nov 2015 finished and product
starting of installation completed
revamping qualifications
Jul 2015- activities starting
acquisition &
project kick-
off

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