INTRODUCING A NEW STANDARD
FOR DRUG SUBSTANCE MANAGEMENT
BASED IN THE
HEART OF THE ALPS
www.susupport.com 2
• Headquarters: KUFSTEIN, AUSTRIA
• Employees: 140
• Founded: 2016
• Turnover: approx. 150 Mio. EUR
“On the basis of single use bags, we offer
biopharma companies access to a new and
100% secure logistics process for liquids.”
FOR THE WHOLE WORLD
www.susupport.com 3
REFERENCES
“Thanks to a fortunate coincidence we got in
touch with SUSupport. Not only have we found a
more than solid solution for our main problem
thanks to their product RoSS® but we now have
access to a clever and 100% safe drug substance
logistics system.”
“The combination of a bag agnostic robust
secondary packaging RoSS and the scalable
plate-based freeze/thaw technologies convinced
us to select Single Use Support.
It not only matches all our requirements, it is
also safe, easy to navigate and flexible to single-
use bags from any supplier.
Furthermore, it is a good starting point to
expand to a whole end-to-end solution.”
www.susupport.com 4
Further references cannot be disclosed due to lack of customer approval.
POTENTIAL FOR DEVELOPMENT
Location Kufstein
- Production space overall
- approx. 1200 m²
- System assembly
- 100 platforms
- Consumables
- e.g. 100.000 RoSS shells
x 3
2021 2022
Location Kufstein & Hall
- Production space overall
- approx. 6000 m²
- System assembly
- 300 platforms
- Consumables
- e.g. 300.000 RoSS shells
POTENTIAL FOR DEVELOPMENT
The implementation of the 2nd location creates the basis for further growth!
BRIDGING THE GAP BETWEEN
DOWNSTREAM AND FILL/FINISH
www.susupport.com 7
• Single Use Support’s BULK.STREAM® closes the gap between Downstream and
Fill & Finish by offering biopharma companies access to a new and secure
management process of liquids in single use bags.
• Single-Use Bag independent and scalable platform for drug substances
ROSS
PROTECT
www.susupport.com 8
1
• RoSS® = Robust Storage and Shipping of bulk drug substance
in single use bags
• Single-use bag covered in 3D foam, protected in robust frame
and stainless-steel lids
• Bag-supplier Independent
• Product loss towards 0%
• Highest achievable storage density (cold room)
• Freedom and space to use sterile connectors
• Scalable platform: (10mL to 50L) for 2D single-use bags
Click here to get read more about RoSS
RoSS Closed
RoSS Open
RoSS.KSET
ROSS.FILL
FILL, FILTER, DRAIN
• Fully automated filling and draining system for single use
bags
• Filling of
• up to 200L of drug substance per batch in less than 1 hour
• 2D and 3D single use bags carrying few mL up to multiple liters
• Highest possible filling accuracy with individual weighing
cells
• Modular system with separate control unit and pumping
station
• Option to take samples
• Option to fill bottles and vials
• Option to include filtration
www.susupport.com 9
2
Click here to get read more about RoSS.FILL
RoSS.FILL Bag
RoSS.FILL Bottle
RoSS.FILL CGT
MANIFOLD ASSEMBLY
CUSTOMIZED SINGLE-USE MANIFOLDS
• 100% customized & fitting: Create your customized one-
stop manifolds solution for safe and comfortable single-
use filling
• Maximum flexibility by designing your systems and
processes according to your needs
• Shortest Lead Times
• 100% quality utilizing gamma or irradiation steriziled
single-use tube assemblies to facilitate an uninterrupted
flow of your drug substance solution that prevents
contamination and product loss.
• Independent from manufacturer of different manifold
components, such as tubings, aseptic connectors, filters,
etc.
• Scalable and modular manifold designs
www.susupport.com 10
3
Click here to get read more about Manifolds
Single-Use Manifolds
Drawing
ROSS.PFTU
FREEZE, THAW
• The plate-based freeze/thaw platform is completely adapted
to the RoSS Shell System
• Scalable from small to big batch sizes:
Lab Scale (< 5L) - Mid Scale (< 70L) –
Large Scale (< 300L) incl. Auto Load Kit
• At highest possible freezing velocity & accuracy
• Compatible with all batch sizes and manufacturers
• Hybrid solution for bags & bottles in one platform
• Freezes down to -90°C
• Best product stability for mAbs and bulk drug substance
through controlled freezing
• Fully automated at highest possible speed and accuracy
www.susupport.com 11
4
RoSS.pFTU Lab Scale
RoSS.pFTU Large Scale
Click here to get read more about RoSS.pFTU
Same freezing kinetics with all scales
ROSS.FRDG
COLD STORAGE
• Refrigerating frozen drug substances for cold storage
• High storage density and stackability of RoSS shells and
RoSS.FRDG itself
• Setpoint temperature ranging from +10°C to -80°C
• High degree of flexibility in-plant due to its portable use
• Ease of use for (un-)loading
• Contains up to 300L of drug substance
• Flexible shelving system and optional loading of either
racks or trolleys carrying RoSS shells
www.susupport.com 12
5
Click here to get read more about RoSS.FRDG
RoSS.FRDG
RoSS.FRDG
ROSS.SHIP
SHIP, TRACK, TRACE
• 100% protection from external mechanical influences
during shipping
• Keeps low temperature for shipping
• Multi-use or single-use
• Complies with international logistics standards
• GPS/G-Force for monitoring temperature and tracking its
geographical location at all times
• Qualification based on ISTA/ASTM 4169
www.susupport.com 13
6
Click here to get read more about RoSS.SHIP
RoSS.SHIP Single-Use
RoSS.SHIP Multi-Use
WHAT ELSE?
www.susupport.com 14
RoSS Trolley RoSS.LIQU
MITS.2D Integrity Test at point of use RoSS.KSET Rack
Premium Service Package Full Qualification incl. IOQ
www.susupport.com
15
Thomas Wurm
Co-CEO & Founder
JOHANNES KIRCHMAIR
Co-CEO & Founder
20+ years biopharma
experience
THOMAS WURM
Co-CEO & Founder
15+ years industrial
experience
SINGLE USE SUPPORT GMBH
Endach 36
6330 Kufstein
Austria/Tyrol
www.susupport.com

Single Use Support - Company Presentation

  • 1.
    INTRODUCING A NEWSTANDARD FOR DRUG SUBSTANCE MANAGEMENT
  • 2.
    BASED IN THE HEARTOF THE ALPS www.susupport.com 2 • Headquarters: KUFSTEIN, AUSTRIA • Employees: 140 • Founded: 2016 • Turnover: approx. 150 Mio. EUR “On the basis of single use bags, we offer biopharma companies access to a new and 100% secure logistics process for liquids.”
  • 3.
    FOR THE WHOLEWORLD www.susupport.com 3
  • 4.
    REFERENCES “Thanks to afortunate coincidence we got in touch with SUSupport. Not only have we found a more than solid solution for our main problem thanks to their product RoSS® but we now have access to a clever and 100% safe drug substance logistics system.” “The combination of a bag agnostic robust secondary packaging RoSS and the scalable plate-based freeze/thaw technologies convinced us to select Single Use Support. It not only matches all our requirements, it is also safe, easy to navigate and flexible to single- use bags from any supplier. Furthermore, it is a good starting point to expand to a whole end-to-end solution.” www.susupport.com 4 Further references cannot be disclosed due to lack of customer approval.
  • 5.
    POTENTIAL FOR DEVELOPMENT LocationKufstein - Production space overall - approx. 1200 m² - System assembly - 100 platforms - Consumables - e.g. 100.000 RoSS shells x 3 2021 2022 Location Kufstein & Hall - Production space overall - approx. 6000 m² - System assembly - 300 platforms - Consumables - e.g. 300.000 RoSS shells
  • 6.
    POTENTIAL FOR DEVELOPMENT Theimplementation of the 2nd location creates the basis for further growth!
  • 7.
    BRIDGING THE GAPBETWEEN DOWNSTREAM AND FILL/FINISH www.susupport.com 7 • Single Use Support’s BULK.STREAM® closes the gap between Downstream and Fill & Finish by offering biopharma companies access to a new and secure management process of liquids in single use bags. • Single-Use Bag independent and scalable platform for drug substances
  • 8.
    ROSS PROTECT www.susupport.com 8 1 • RoSS®= Robust Storage and Shipping of bulk drug substance in single use bags • Single-use bag covered in 3D foam, protected in robust frame and stainless-steel lids • Bag-supplier Independent • Product loss towards 0% • Highest achievable storage density (cold room) • Freedom and space to use sterile connectors • Scalable platform: (10mL to 50L) for 2D single-use bags Click here to get read more about RoSS RoSS Closed RoSS Open RoSS.KSET
  • 9.
    ROSS.FILL FILL, FILTER, DRAIN •Fully automated filling and draining system for single use bags • Filling of • up to 200L of drug substance per batch in less than 1 hour • 2D and 3D single use bags carrying few mL up to multiple liters • Highest possible filling accuracy with individual weighing cells • Modular system with separate control unit and pumping station • Option to take samples • Option to fill bottles and vials • Option to include filtration www.susupport.com 9 2 Click here to get read more about RoSS.FILL RoSS.FILL Bag RoSS.FILL Bottle RoSS.FILL CGT
  • 10.
    MANIFOLD ASSEMBLY CUSTOMIZED SINGLE-USEMANIFOLDS • 100% customized & fitting: Create your customized one- stop manifolds solution for safe and comfortable single- use filling • Maximum flexibility by designing your systems and processes according to your needs • Shortest Lead Times • 100% quality utilizing gamma or irradiation steriziled single-use tube assemblies to facilitate an uninterrupted flow of your drug substance solution that prevents contamination and product loss. • Independent from manufacturer of different manifold components, such as tubings, aseptic connectors, filters, etc. • Scalable and modular manifold designs www.susupport.com 10 3 Click here to get read more about Manifolds Single-Use Manifolds Drawing
  • 11.
    ROSS.PFTU FREEZE, THAW • Theplate-based freeze/thaw platform is completely adapted to the RoSS Shell System • Scalable from small to big batch sizes: Lab Scale (< 5L) - Mid Scale (< 70L) – Large Scale (< 300L) incl. Auto Load Kit • At highest possible freezing velocity & accuracy • Compatible with all batch sizes and manufacturers • Hybrid solution for bags & bottles in one platform • Freezes down to -90°C • Best product stability for mAbs and bulk drug substance through controlled freezing • Fully automated at highest possible speed and accuracy www.susupport.com 11 4 RoSS.pFTU Lab Scale RoSS.pFTU Large Scale Click here to get read more about RoSS.pFTU Same freezing kinetics with all scales
  • 12.
    ROSS.FRDG COLD STORAGE • Refrigeratingfrozen drug substances for cold storage • High storage density and stackability of RoSS shells and RoSS.FRDG itself • Setpoint temperature ranging from +10°C to -80°C • High degree of flexibility in-plant due to its portable use • Ease of use for (un-)loading • Contains up to 300L of drug substance • Flexible shelving system and optional loading of either racks or trolleys carrying RoSS shells www.susupport.com 12 5 Click here to get read more about RoSS.FRDG RoSS.FRDG RoSS.FRDG
  • 13.
    ROSS.SHIP SHIP, TRACK, TRACE •100% protection from external mechanical influences during shipping • Keeps low temperature for shipping • Multi-use or single-use • Complies with international logistics standards • GPS/G-Force for monitoring temperature and tracking its geographical location at all times • Qualification based on ISTA/ASTM 4169 www.susupport.com 13 6 Click here to get read more about RoSS.SHIP RoSS.SHIP Single-Use RoSS.SHIP Multi-Use
  • 14.
    WHAT ELSE? www.susupport.com 14 RoSSTrolley RoSS.LIQU MITS.2D Integrity Test at point of use RoSS.KSET Rack Premium Service Package Full Qualification incl. IOQ
  • 15.
    www.susupport.com 15 Thomas Wurm Co-CEO &Founder JOHANNES KIRCHMAIR Co-CEO & Founder 20+ years biopharma experience THOMAS WURM Co-CEO & Founder 15+ years industrial experience SINGLE USE SUPPORT GMBH Endach 36 6330 Kufstein Austria/Tyrol www.susupport.com