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Introduction of Tofflon’s mAb Capabilities and Systems

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:

?        Lower operating costs and downtime

?        Fewer clean room personnel required

?        Higher level of sterility assurance

?        Reduced potential bioburden and cross contamination

?        Increased personnel and product safety

?        Repeatable processes and standards

?        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

?        Chromatography columns and systems

?        Virus filtration

?        Ultrafiltration concentration

Final filtration and fill & finish

?        Compounding and formulation systems

?        Final filtration systems

?        Fill & finish systems with integrated isolators

Process system

?        Media/buffer preparation/storage/distribution

?        Process vessels CIP/SIP systems

?        Process liquid waste inactivation

?        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

?        Low upfront CAPEX and fast setup

?        Highly flexible and rapid cGMP modular designs

?        No CIP/SIP and minimal process cleanroom areas and waste liquid handling required

?        50 L to 2000 L systems available using Thermofisher, Sartorius, and GE’s Single Use Bioreactor bags

?        Integrated bioreactor controllers to ensure the unity of control at all production stages

?        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:

?        Changeable mixing components can adapt to process needs

?        Magnetic stirring - scalable, sterile, and affordable maintenance

?        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

?        The batch/fed-batch/continuous perfusion culture of cells.

?        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

?        3D controlled bending and precise machining.

?        Mixing systems scalable high efficiency at low to high volume similar to top global brands.

?        Load cell, famous international brand

?        2mm thick SS304 honeycomb jacket design for better quality and heat transfers

Depth Filtration

?        Depth filter system used to clarify cell harvest fluid.

?        Up to 4 grades of depth filters can be used independently, in parallel or in series.

?        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

?        Designed in accordance with cGMP and FDA requirements for downstream bioprocessing of biopharmaceuticals

?        Chrom systems are fully automatic from pilot to industrial scale

?        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

?        Imported barrel finishing acrylic column, material comply with the FDA & USP requirements.

?        Double O ring is used to seal between stigma and barrel for robust operations

?        Column drum can be turned to the side for easy maintenance of the bottom sieve/frit.

?        Optimized design with no dead legs, no residue and minimized hold up volume.

?        Unique distribution design for fluid full diffusion.

Virus Filtration

?        The virus filtration system can hold up to 4 virus filtration line, which can be used independently or in parallel,

?        and disassembled conveniently.

?        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

?        High quality construction and design to ensure best recovery of products.

?        Low operating cost with more efficient cross flows and recovery.

?        Reduce the load volume on subsequent processes.

?        Minimal operator requirement for operation.

?        Adaptable to use with Pall’s or other brand’s membrane package.

Media & Buffer Preparation/ Storage/Distribution

?        Flexible use of disposable and stainless-steel mixing systems.

?        Adapting 3D visual modeling design to perfectly match the overall engineering requirements and facility design.

?        Optimized designs for efficient transfer of aqueous solutions and products.

?        Low hold up volumes with proper slope for recovery.

?        Stainless steel systems can be integrated with CIP/SIP.

?        High performance CIP systems with controlled liquid supply flow and pressure nozzles to meet the cleaning requirements of different vessels.