Integrated Solution for mAb Manufacturing Platform
Tofflon is dedicated to develop the advanced biotechnology manufacturing
solution for biopharmaceutical manufacturing facilities from media preparation,
cell/microbial cultivation, harvesting, DF/ UF, purification, buffer
preparation to fill & finish. And Tofflon integrated solution for mab
manufacturing platform with features as below:
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Lower operating costs and downtime
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Fewer clean room personnel required
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Higher level of sterility assurance
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Reduced potential bioburden and cross contamination
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Increased personnel and product safety
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Repeatable processes and standards
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Less reliance on personnel interventions and SOP’s
Bioprocessing Systems and Solutions
Upstream: Cell Culture
• Bioreactors-Stainless and Single Use
Harvest: Cell separation and
clarification
• Harvest and surge vessels
• Depth filtration systems
Downstream: Purification
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Chromatography columns and systems
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Virus filtration
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Ultrafiltration concentration
Final filtration and fill & finish
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Compounding and formulation systems
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Final filtration systems
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Fill & finish systems with integrated isolators
Process system
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Media/buffer preparation/storage/distribution
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Process vessels CIP/SIP systems
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Process liquid waste inactivation
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PAT-ILD /PAT-ILC
Hybrid Approaches with Stainless-Steel and
Single-Use Systems
Stainless steel boasts a long history in biopharma manufacturing, but single-use systems offer reduced cleaning and validation – and are gaining ground fast. Many companies are reaping the unique benefits of both by implementing hybrid approaches.
To build a stainless-steel plant and
then implement some single-use systems for certain processes to make them more
efficient or cost effective. Tofflon can provide the hybrid solution for
building familiarity and confidence in single-use systems while maintaining
production capacity.
Single Use Bioreactor
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Low upfront CAPEX and fast setup
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Highly flexible and rapid cGMP modular designs
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No CIP/SIP and minimal process cleanroom areas and waste
liquid handling required
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50 L to 2000 L systems available using Thermofisher,
Sartorius, and GE’s Single Use Bioreactor bags
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Integrated bioreactor controllers to ensure the unity of
control at all production stages
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With flexible control signal interface to integrate the
cell culture data from electrodes, exhaust gas analyzer, glucose sensor and
other analytical analyzers
Stainless Steel Bioreactor:
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Changeable mixing components can adapt to process needs
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Magnetic stirring - scalable, sterile, and affordable
maintenance
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Automatic one-key operations, CIP/SIP/, inoculating/feeding,
reduce the operation and training difficulty of personnel
• Current manufacturing scale can reach 500kL
Features of Bioprocessing Systems and Solutions
Stainless Steel Bioreactor
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The batch/fed-batch/continuous perfusion culture of cells.
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Process R&D, pilot scale, commercial scale production.
• These systems are optimized to the macromolecular biological products such as vaccine, monoclonal antibody, insulin, genetic engineering products, recombinant protein products & etc.
Single Use Bioreactor
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3D controlled bending and precise machining.
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Mixing systems scalable high efficiency at low to high
volume similar to top global brands.
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Load cell, famous international brand
• 2mm thick SS304 honeycomb jacket design for better quality and heat transfers
Depth Filtration
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Depth filter system used to clarify cell harvest fluid.
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Up to 4 grades of depth filters can be used independently,
in parallel or in series.
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Easy setup and disassembly with manual hydraulic pressure
pump and gauge.
• Adaptable to use with Millipore’s and other barnd’s depth filters
Chromatography System
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Designed in accordance with cGMP and FDA requirements for
downstream bioprocessing of biopharmaceuticals
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Chrom systems are fully automatic from pilot to industrial
scale
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High quality engineering and product quality guarantee
process stability, control and reproducibility.
• All components from inlets to outlets in the LPLC system meet regulatory requirements which are traceable
Chromatography Column
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Imported barrel finishing acrylic column, material comply
with the FDA & USP Ⅵ requirements.
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Double O ring is used to seal between stigma and barrel
for robust operations
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Column drum can be turned to the side for easy maintenance
of the bottom sieve/frit.
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Optimized design with no dead legs, no residue and
minimized hold up volume.
• Unique distribution design for fluid full diffusion.
Virus Filtration
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The virus filtration system can hold up to 4 virus
filtration line, which can be used independently or in parallel,
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and disassembled conveniently.
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Easy setup and disassembly with manual hydraulic pressure
pump and gauge.
• Adaptable to use with Millipore’s or other brand’s virus filters.
Ultrafiltration Concentration
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High quality construction and design to ensure best
recovery of products.
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Low operating cost with more efficient cross flows and
recovery.
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Reduce the load volume on subsequent processes.
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Minimal operator requirement for operation.
• Adaptable to use with Pall’s or other brand’s membrane package.
Media & Buffer Preparation/ Storage/Distribution
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Flexible use of disposable and stainless-steel mixing
systems.
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Adapting 3D visual modeling design to perfectly match the
overall engineering requirements and facility design.
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Optimized designs for efficient transfer of aqueous
solutions and products.
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Low hold up volumes with proper slope for recovery.
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Stainless steel systems can be integrated with CIP/SIP.
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High performance CIP systems with controlled liquid supply
flow and pressure nozzles to meet the cleaning requirements of different
vessels.