dispensing and isolation technology solutions for pharma ... · since the late’00s comecer has...

16
Dispensing and Isolation Technology Solutions for Pharma & Radiopharma applications

Upload: others

Post on 25-Jul-2020

0 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

Dispensing and Isolation Technology Solutions for Pharma & Radiopharma applications

Page 2: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

An International Group

Page 3: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

More than 40 Years Experience

1970 Comecer was founded as a technology supplier for the Italian Nuclear Agency (ANI). Partnership with ENEA and Ansaldo are established developing multiple prototypes and innovative products

1980 Due to the 1985 nuclear energy development stop in Italy, Comecer moved its competence and know-how to the medical field (safety solutions for nuclear medicine labs)

1990 Acquisition and mastering of the stainless steel manufacturing technology with wide application on Comecer products

2000 Development of key agreements with research and technology partners for customized nuclear medicine product development

2010 Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high tech solutions focusing on improving accuracy and safety in the nuclear medicine and isolation technology sectors.

2011 Fondo Italiano di Investimento has reached an agreement for the entry with a minority stake in Comecer

2012 Acquisition by Comecer S.p.a. of Veenstra Instrumenten B.V. (Netherlands) and Brita Trade (Czech Republic)

2015 The operator Principia SGR acquired the minority stake in the company, taking over the Italian Investment Fund with the medium-term objective of listing the company on the Stock Exchange.

Page 4: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

Headquartered in Italy

Page 5: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

Committed to Sustainability

Safety First

Working for a better world

Human beings at the centre of the system

Page 6: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

Added Value

Internal Engineering R&D and Manufacturing

High quality standard patents

Internal TIG Welding Process

Page 7: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

Our Human Resources

EMPLOYEES TODAY

Data updated to April 2018

Page 8: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

Employee growth

95 112

140

170 188

215

280

320 314 299 302

315

0

50

100

150

200

250

300

350

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

57%

23%

10%

7% 3%

Quality & Validation

Finance & Accounting Sales & Marketing Engineering – R&D Manufacturing

Page 9: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

2017 Production Value: 66,5 Million Euros

Italy 13%

Americas 15%

Europe 58%

RoW 14%

Revenues by Geographic Area

Page 10: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

Primary Pharmaceutical Production

Fill Finish Manufacturing Regenerative Medicine

R&D, Laboratory and Hospital Pharmacy

Aseptic Food Processing Aerospace & Semiconductor Manufacturing

«Tailor made» solutions for Pharmaceutical and Regenerative Medicine

Page 11: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

Application for Nuclear Medicine and GMP Radiopharmacy

Page 12: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

One Manufacturer Practices

Support and consulting services to clients in the design and realization of pharma and radiopharma production centers or PET laboratories with full GMP compliance.

LAYOUT & SITE PLANNING

1

DESIGN QUALIFICATION

2

COMMISSIONING & EQUIPMENT

INSTALLATION

3

QUALIFICATION ACTIVITIES

4

DEDICATED TRAINING

5

PROCESS VALIDATION

6

Page 13: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

Validations and Standards

FAT

Factory Acceptance Test

SAT

Site Acceptance Test

IQ & OQ protocols

Installation Qualification & Operational Qualification

ISO 14644 Cleanrooms and associated controlled Environments

ISO 10648 Containment enclosures

EEC-GMP Good Manufacturing Practice - Annex 1 Manufacture of Sterile Medicinal Products

PDA – TR Nr. 34 Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care products

Page 14: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

Over 1000 Installation Worldwide • Argentina • Australia • Austria • Belgium • Brazil • Canada • Chile • China • Croatia • Czech Republic • Denmark • Egypt • Ecuador • Finland • France • Germany • Greece • Hungary

• India • Indonesia • Italy • Japan • Kazakhstan • Kuwait • Libya • Luxembourg • Malaysia • Mexico • Morocco • New Zealand • Pakistan • Philippines • Poland • Portugal • Romania • Russian

• South Korea • Spain • Sweden • Switzerland • Singapore • Taiwan • Thailand • The Netherlands • Turkey • UAE • Ukraine • United Kingdom • Uruguay • USA • Venezuela • Vietnam • Saudi Arabia • South Africa

Page 15: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

Main Exhibitions

Nuclear Medicine & Radiopharma Pharmaceutical & Regenerative Medicine

EANM - European Association of Nuclear Medicine

SNMMI - Society of Nuclear Medicine and Molecular Imaging Pharmtech & Ingredients

FCE - International Technology Expo for the Pharmaceutical Industry

Page 16: Dispensing and Isolation Technology Solutions for Pharma ... · Since the late’00s Comecer has become a reference partner for designing, manufacturing, and world-wide offer of high

www.comecer.com