Main competitors for Celsius FFT

Transcription

1 Main competitors for Celsius FFT COMPETITORS PRODUCT NAMES Acclimate Nalgene Bio process BagManage ment System BioShell Freeze-Pak STS Glass/Plastic Bottles & Carboys Unprotected Single-use Bags PICTURES COMMMENTS 2D EVA SU bag with protective container Product range from 2L to 16L Robust down to -80 C Tuft design for uniform fluid distribution Container system to protect frozen SU bags Fit with any 2D single-use bags Protect the bags down to - 80 c Insulated Shipper available Container system to protect frozen SU bags Fit with any 2D Single-use bags Protect the bags down to -80 c Insulated shipper available Non-protected 2D su bag From 50ml to 20L Robust performances down to -80 c Secondary shipping containers Not scalable Not scalable

2 Thermo Scientific - ASI - Acclimate Product Description 2D EVA SU bag with protective container Product range from 2L to 16L Robust down to -80 C Tuft design for uniform fluid distribution Strength 2D SU bag with protective container Product range from 2L up to 16L bag Robust down to -80 c Sample bag connected to container (option) Tuft Design aids in uniform fluid distribution and uniform expansion during freezing / thawing cycles Stackable New comer (2014) with lack of references and no exprience on freeze-thaw Not a ready-to-use solution Complex operation No Access to Transfer Lines Limited qualification & validation package No shippers

3 Thermo Scientific - Nalgene Bioprocess Bag Management System Product Description Container system to protect frozen SU bags Fit with any 2D single-use bags Protect the bags down to -80 c Insulated Shipper available Strength Can fit 2D bags from all manufacturer Robust down to -80 c UV protective and transparent shells Stackable and Nestable Autoclavable shells Insulated shipper complies with the ISTA 2A (mechanical validation) and hold bags below -50 c for at least 72 hours Limited for 5L & 20L bags (Max. 17L Fill Vol.) Not a ready-to-use solution Complex operation No Access to transfer lines Need support from IInd party (SU supplier) Everything possible but nothing is qualified! Who is responsible in case of failure? Minimal qualification in the shipping area

4 UFP Technologies - Bioshell Product Description Container system to protect frozen SU bags Fit with any 2D Single-use bags Protect the bags down to -80 c Insulated shipper available Strength Can fit 2D bags from all manufacturer Robust down to -80 c Multi-purpose (work with liquid) UV protective and transparent shells Reusable & recyclable Insulated shipper to ship frozen bags inside Bioshell Limited for bags up to 8L Not a ready-to-use solution Complex operation No Access to Transfer Lines Need support from IInd party (SU supplier) Everything possible but nothing is qualified! Who is responsible in case of failure? Minimal qualification in the shipping area

5 Charter Medical Freeze-Pak STS Product Description Non-protected 2D Polyolefin Single-use bag Product range from 50ml to 20L Robust performances down to -80 c Single-use secondary shipping containers Strength Full validation package available upon request and includes data on extractable and protein adsorption Low pricing strategy Robust down to -80 c 300µm Polyolefin film remains flexible to temperature as low as -196 C Product Range from50ml to 20L Secondary shipping containers Focus in US and niche markets Weak film validation & functional qualification at low temps. 20L bag nominal fill volume limited to 17L SU assemblies proned to damages Secondary shipping containers is not a shipper ( Pizza Box ), limited to 5L bag (for V>5L they recommend Bioshell ) and require complex operations

6 Glass/Plastic Bottles & Carboys Proned to Physical Damages Challenges for Aseptic Processes Cleaning & sterilization Activities Higher Risk for Microbial Growth Poor Freeze Thaw Performances Non-Adapted Logistics Limited Validation Package Why converting to Celsius FFT? 2D bag and transfer lines fully protected Unprecedented functional qualification at low temperature down to -70 c Fully disposable technology for closed aseptic processes Designed to enhance Manufacturing Processes Flexibility Contoured thin shell design to promote heat transfer and for consistent freeze and thaw performances Ease-of-use; Right-sized for a single-operator; Stackable; Manual or Automated multi-fill operation; Pre-qualified shippers Celsius VG & EG to fully support the end-users in moving to Celsius FFT Celsius FFT is not expected to be competing against glass/plastic bottles and carboys on pricing. Celsius FFT is a premium technology to address the market demand in robust single-use containers at low temperatures for highvalue biopharmaceutical products in critical application (Product Intermediates, Bulk Drug Substance). Conversion from bottles to Celsius FFT will significantly reduce the overall operational manufacturing costs.

7 Why is Celsius FFT better positioned over to the competition? Market Adoption 13 years 'experience in single use freezing with Celsius platform Celsius FFT is used in 8 major commercial application (BDS storage) Unprecedented level of film validation and characterization Strong available documentation to support and facilitate implementation of S71 film as contact material for the primary container of BDS storage application Design Features Celsius FFT combines a 2D bag and transfer lines fully protected by 2 HDPE protective shells, preassembled, gamma irradiated and ready to use out of the box for confident handling

8 Why is Celsius FFT better positioned over to the competition? Reliable Solution SSB takes the complete responsibility with the full ownership and control throughout the product life cycle Broadest product offering From 0.5 to 12 L Fill Volume to bracket small to medium batch size for production scale (30ml and 100 ml Celsius Pak available for stability studies). Move to Celsius FFT for larger batch size Ease of Use Fill, transfer to freezer; move to thaw area. Thaw & drain. Right-sized for single use operator Efficient Freeze Thaw Process Celsius FFT fits perfectly with existing infrastructure (lab freezers, custom blast freezers, cold rooms, tabletop/ambient, hot room, water bath, shaker, incubator)

9 Why is Celsius FFT better positioned over to the competition? Flexible for easy of implementation Large access holes on top and bottom of the shell to visualize the product during process steps Multi fill operation (manual and semi-automated) and multiple configurations possible through the SSB FMT solutions Celsius FFT are stackable, entirely recyclable and FFT shells may be re-used Robust at low temperatures Fully functional qualification package at low temps.(250 tests in real process conditions, all bag sizes, min. and max. fill volume, extreme FT conditions, frozen drop tests and shipping tests) Pre-qualified shippers Dedicated pre-qualified shippers for all Celsius FFT sizes Simple (Dry-ice pack out and ship) Passed the ASTM 4169 AL1 shipping test (mechanical performances) passed the ISTA 7D Extreme Summer and Winter temperature profiles shipping test (maintain product below - 4O C for at least 96h)