Nanotechnologie in Entwicklung & Produktion in Diagnostik ......29.05.2017 MILESTONES STRATEC’s...

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31.05.2017

Nanotechnologie in Entwicklung &

Produktion in Diagnostik, Life Science

und Medizintechnik

Vienna

29.05.2017 Confidential 2

1. Vorstellung STRATEC Consumables

2. Herstellungstechnologien bei STRATEC Consumables

3. Beispiel für ein Entwicklungsprojekt: Fianostics

4. Beispiel für eine Massenproduktion: Quanterix

Überblick

29.05.2017 Confidential 3

1. Vorstellung STRATEC Consumables

2. Herstellungstechnologien bei STRATEC Consumables

3. Beispiel für ein Entwicklungsprojekt: Fianostics

4. Beispiel für eine Massenproduktion: Quanterix

Überblick

29.05.2017

MILESTONES

STRATEC’s HISTORY

1979 STRATEC is founded in Birkenfeld, Germany

1987 First medical systems are developed

1993 Launch of a bio- and chemi-luminescence system

1998 STRATEC becomes a stock corporation

2005 Swiss manufacturing site is founded

2006 Acquisition of STRATEC Biomedical UK (formerly Sanguin International Ltd.)

2008 STRATEC Biomedical SRL is founded in Romania

2009 Acquisition of STRATEC Molecular, Berlin, Germany

(formerly Invitek Gesellschaft für Biotechnik & Biodesign mbH)

2010 Acquisition of STRATEC Biomedical USA (formerly Ballista Inc.)

2013 STRATEC Biomedical (Taicang) is founded in China

2016 Acquisition of Diatron, Budapest, Hungary

2016 Acquisition of Sony DADC BioSciences, Austria

Confidential 4

29.05.2017

Consulting

Instrumentation

Automation

Middleware

Technology pool

Intellectual property rights

Expanded offering

Smaller instruments (POC, benchtop)

Consumables

OEM development and manufacturing of integrated

solutions for reagent and instrument partners

STRATEC’s BUSINESS OBJECTIVE

“PANTHER” for Hologic Gen-Probe

Confidential 5

29.05.2017 Confidential 6

PARTNERS AND ANALYZERS

29.05.2017 Confidential 7

COMPANY PROFILE

STRATEC CONSUMABLES HISTORY

Foundation of Sony DADC BioSciences as a division

ISO 13485 certification

BioSciences becomes an independent BU

BioSciences opens offices in the US & Japan

Sony DADC BioSciences GmbH, own legal entity

STRATEC Consumables GmbH founded

29.05.2017 Confidential 8

1. Vorstellung STRATEC Consumables

2. Herstellungstechnologien bei STRATEC Consumables

3. Beispiel für ein Entwicklungsprojekt: Fianostics

4. Beispiel für eine Massenproduktion: Quanterix

Überblick

29.05.2017 Confidential 9

Mastering

Fabrication

Back-end

processing

Quality Assurance | Quality Control | ISO 13485

SERVICE PORTFOLIO

native surface coated surface

11/2016 Public 10

Structures from 200 nm to 200 µm Structures from 200 nm to 200 µm

Mas

teri

ng

SERVICE PORTFOLIO

11/2016 Public 11

Handling your individual format Handling your individual format

Inje

ctio

n M

old

ing

SERVICE PORTFOLIO

11/2016 Public 12

High precision bonding High precision bonding

Bo

ndin

g

SERVICE PORTFOLIO

11/2016 Public 13

Reproducible and clean Reproducible and clean

Bo

ndin

g

SERVICE PORTFOLIO

11/2016 Public 14

Developed for your requirements Developed for your requirements

Ass

em

bly

SERVICE PORTFOLIO

11/2016 Public 15

100 % in-line check 100 % in-line check

QA

& Q

C

SERVICE PORTFOLIO

29.05.2017 Confidential 16

1. Vorstellung STRATEC Consumables

2. Herstellungstechnologien bei STRATEC Consumables

3. Beispiel für ein Entwicklungsprojekt: Fianostics

4. Beispiel für eine Massenproduktion: Quanterix

Überblick

29.05.2017 Confidential 17

COLLABORATION Fianostics & STRATEC

29.05.2017 Confidential 18

COLLABORATION Fianostics & STRATEC

29.05.2017 Confidential 19

COLLABORATION Fianostics & STRATEC

29.05.2017 Confidential 20

COLLABORATION Fianostics & STRATEC

29.05.2017 Confidential 21

COLLABORATION Fianostics & STRATEC

29.05.2017 Confidential 22

1. Vorstellung STRATEC Consumables

2. Herstellungstechnologien bei STRATEC Consumables

3. Beispiel für ein Entwicklungsprojekt: Fianostics

4. Beispiel für eine Massenproduktion: Quanterix

Überblick

29.05.2017 Confidential 23

Proof of principle:

Fabrication of micro wells

by etching into glass fibers

D- M. Rissing et al., Nat Biotechnol. 2010 June ; 28(6): 595–599. doi:10.1038/nbt.1641

FROM PROTOTYPE TO PRODUCTION

29.05.2017 Confidential 24

Proof of principle:

Fabrication of micro wells

by etching into glass fibers

Transfer to polymer:

Prototyping by Hot embossing

into COC on

microscope slide format

FROM PROTOTYPE TO PRODUCTION

29.05.2017 Confidential 25

Proof of principle:

Fabrication of micro wells

by etching into glass fibers

Transfer to polymer:

Prototyping by Hot embossing

into COC on

microscope slide format

Transfer to high volume processes:

Injection molding of micro wells

Enhancing number of flow cells per sample

by using disc shape

Setup of processes at STRATEC:

injection molding of clear and black disc, Laser welding

and packaging

FROM PROTOTYPE TO PRODUCTION

24-array disc C

10 µm

29.05.2017 Confidential 26

FROM PROTOTYPE TO PRODUCTION

From low to medium volume:

Installation of multi cavity mold

Cycle time reduction by automation

laser welding loading

QC limits adjusted

Prototyping

(1-1000 units)

ga

p

Succesful Productization

R&D

Prototyping

(1-1000 units)

Mass Manufacturing

1000 – 1 Mio

From medium to high volume:

Cycle time reduction by introducing mask

laser welding

Cycle time reduction by automation of mask

laser welding

Cost reduction by inline quality control

Confidential 27 29.05.2017

Instrument Consumable Optical Analysis

We can offer you a complete product solution

FROM PROTOTYPE TO PRODUCTION

0 aM

3.5 aM

350 aM

3.5 fM

29.05.2017 Confidential 28

Sony

Co

rpo

ratio

n

Precision bonding Precision bonding

PRODUCTS

29.05.2017 Confidential 29

MyC

artis

Microfluidics in MTP format Microfluidics in MTP format

PRODUCTS

29.05.2017 Confidential 30

Sin

gule

x Monolithic injection molding Monolithic injection molding

PRODUCTS

29.05.2017 Confidential 31

Rai

nD

ance

Tech

nolo

gies Customized format in three generations Customized format in three generations

PRODUCTS

29.05.2017 Confidential 32

LET US KNOW YOUR CHALLENGES…

THANK YOU

FOR YOUR ATTENTION!

Sonystr. 20

5081 Anif

Austria

Phone: +43 6246 880-8313

Fax: +43 6246 880-9187

consumables.stratec.com

CONTACT

Iris Bergmair

i.bergmair@stratec.com

THANK YOU FOR YOUR

ATTENTION!