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AppliFlex ST GMP

The single-use bioreactor for clinical applications

The AppliFlex ST GMP* is a customizable single-use bioreactor that is designed to meet all cGMP requirements for clinical CGT applications. It enables a seamless process transition from R&D to clinical production.

Contact us for more information

Your interest in bioreactor systems

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.  

Argentina

AP Biotech
Phone: +541142921611
Email: info@apbiotech.com.ar
URL: www.apbiotech.com.ar

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.  

Brazil

Sotelab
+55 (21) 3392-3563
www.sotelab.com.br

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.  

Chile, Peru

AP Bioprocess
www.ap-bioprocess.com

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Colombia

Intek Group
Phone: +57 316 3550400 - 749 8437
Email: contacto@intekgroup.com.co
URL: www.intekgroup.com.co

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Czech Republic

Vekamaf
Phone: +420 284 690 881
URL: www.vekamaf.cz

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Denmark

Holm & Halby
Phone: +454326 9400
Email: info@holm-halby.dk
URL: www.holm-halby.dk

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Estonia

Bio Techa
Phone: +372 6597101
Email: info@biotecha.ee
URL: www.biotecha.lt

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Hungary

Holimex
Phone: +36 1 391 4400
URL: www.holimex.hu

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

India

Spinco Biotech Pvt. Ltd.
Phone: +91 44 45678900
Email: info@spincotech.com
URL: www.spincotech.com

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Indonesia

PT Arico Sainsindo Nusantara
Phone: +62-21 580 6342 / 3
Email: arico@dnet.net.id
URL: www.ptarico.com

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.  

Ireland

Asistec
Phone: +353(0)1286 8796
Email: info@asistec.ie
URL: www.asistec.ie

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Israel

Medent Group
Phone: +97286237984
Email: info@medent.co.il
URL: medent.co.il

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Italy

Steroglass
Phone: +39 075 609091
Email: info@steroglass.it 
URL: www.steroglass.it

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Japan

Sanyo Trading Co., LTD
Phone: +81-3-3518-1196
URL: www.sanyo-trading.co.jp

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Lithuania

Bio Techa
Phone: +370 5 237 60 07
Email: info@biotecha.lt
URL: www.biotecha.lt

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Norway

Bio Nordica
Phone: 23 03 58 00
Email: info@bionordika.no
URL: bionordika.no

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Poland

Labo Baza
Phone: +4861 812 57 45
Email: biuro@labobaza.pl
URL: www.labobaza.pl

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Portugal

Aplitech Biolab
Phone: +34 629818802
www.aplitechbiolab.com

 

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Russia

Abtek
Phone: +7(495) 723-64-97
Email: abtek@abtek.ru
URL: abtek.ru

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Singapore

Zil Sci Pte. Ltd.
Phone: +65 6767 2929
Email: ENQUIRY@ZILSCI.COM
URL: www.zilsci.com

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Slovakia

Vekamaf
Phone: +421-2-52932891
URL: www.vekamaf.cz

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

South Africa

Seperations
Phone: +27 11 919 1000
Email: info@separations.co.za
URL: separations.co.za

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

South Korea

SeouLin Bioscience
Phone: +821670-5911
Email: support@seoulin.co.kr
URL: www.seoulin.co.kr

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Spain

Aplitech Biolab
Phone: +34 629818802
www.aplitechbiolab.com

 

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Switzerland

Resea Biotec
Phone: +41 34 531 08 20
Email: office@reseabiotec.ch
URL: www.reseabiotec.ch

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Taiwan

Tseng Hsiang Life Science Ltd.
Phone: +862-27851156
Email: info@thco.com.tw
URL: www.thco.com.tw

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Meditop Co., Ltd

Holm & Halby
Phone: +662 9331133
Email: info@meditopthailand.com
URL: meditopthailand.com

We have a local distributor for this country. Feel free to reach out directly via below phone number, email or website for quickest response.

Turkey

Ant Teknik
Phone: +90 216 422 6700
Email: antteknik@antteknik.com 
URL: www.antteknik.com

The 3 liter single-use bioreactor for clinical applications
The 500 mL single-use bioreactor for clinical applications

Single-use bioreactor for Cell & Gene Therapy and mRNA applications

  • Seamless process transition from research to clinical production (both scale up and scale out)
  • Designed to meet the requirements for clinical production, such as material requirements, traceability, particle requirements and much more
  • Builds on the proven customization ability of the AppliFlex ST for research and development purposes

The AppliFlex ST GMP is available in 500 mL and 3 L and can be customized to your requirements. 

Turnkey package

Leveraging our expertise, we can provide a turnkey lab-scale cGMP manufacturing platform to get you started right away. This package consists of the single-use AppliFlex ST GMP bioreactor, a control tower, software solutions and services like installation, verification and training. 

Bring this single-use bioreactor straight to your cleanroom through AR

Are you interested in the single-use bioreactor, and would you like to get a virtual sample right now? Try these bioreactors in Augmented Reality*.

Scan the QR code on your desktop with your mobile device or click on the link directly on the mobile device and discover how the AppliFlex ST GMP would be on your bench.

*View this page on an Augmented Reality (AR) compatible device. Augmented Reality (AR) adds digital elements to the camera of your smartphone, creating the illusion that holographic content is a part of a physical world around you.

AppliFlex ST GMP 500 mL in Augmented Reality in cleanroom

AppliFlex ST GMP 500 mL

Discover how this 500 mL single-use bioreactor will look in your cleanroom.


AppliFlex ST 500ml.png

*Disclaimer
Purpose/intended use: Getinge’s GMP compliant systems are intended to be used in GMP compliant production and research environments. The system is not intended to be used as a medical device.

Easy scale up and scale out

Following the strictest cGMP standards, the AppliFlex ST GMP reduces the challenges of process transfer to clinical production. The AppliFlex ST GMP leverages your development and validation work into a GMP design and production workflow for 500 mL and 3 L bioreactor systems.

Save time and costs by skipping the process transfer step moving to clinical production, and thereby reduce your time-to-market.

Full customizable design

3D printing technology allows for easy optimization of the bioreactor to match your process and application. The headplate can be configured to your unique needs from special ports, sampling lines, connectors, and spargers to addition bottles.

The unique design and verification of the AppliFlex ST GMP allows you to keep this flexibility while being compliant with cGMP standards. Bring your design to life with a custom AppliFlex ST GMP.

No cross-contamination

The AppliFlex ST GMP is a fully closed system. A wide range of aseptic connectors can be placed to reduce handling operations. Design has been optimized to reduce handling and make operation easy.

Using single-use sensors allows for a fully closed operation, ensuring sterility in your bioprocess.

Specifications

Physical characteristics  500 mL 3 L

Dimensions ( h x Ø ) 236 mm x 75 mm 340 mm x 130 mm
Weight 0.2 kg (1 bioreactor) 0.7 kg (1 bioreactor)
Bottom Dished bottom
Total volume 575 ml 3 L
Working volume 100 – 400 ml 0.65 – 2.4L
H/D ratio total volume 2.0
H/D ratio working volume 1.33
Impeller type Marine / Rushton / Anchor / None / Hydrofoil / Helical and more...
Impeller diameter Customizable -xx- mm 52 mm
Sparger type Pipe with Ø2mm hole / Open pipe / Sparger stone / Jet sparger / Porous sparger and more...
Operating conditions
Working temperature 5 – 45 °C
Storage temperature -80 – 45 °C
Design pressure 0 – 0.5 barg 0 – 0.1 barg
Mixing time ~3 seconds
Sterilization >25 kGy Gamma irradiation
Sensors options Single-use sensors or traditional multi-use sensors

*Disclaimer
Purpose/intended use: Getinge’s GMP compliant systems are intended to be used in GMP compliant production and research environments. The system is not intended to be used as a medical device.

*Disclaimer
Purpose/intended use: Getinge’s GMP compliant systems are intended to be used in GMP compliant production and research environments. The system is not intended to be used as a medical device.