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Gene Therapy
医薬品製造開発

Gene Therapy & Oncolytic Viruses

Industrialized solutions for the production of viral vectors

The development of safe and effective viral vectors has accelerated the development of viral based therapies to treat a wide range of diseases.  This has significantly increased the number of trials at all clinical stages as a growing number of approved therapies reach the market. This rapid rise has not been matched by the commonplace application of technologies that facilitate the industrialization of these processes.  Traditional technology, while seen to work well at a small scale, simply struggles to deliver the desired economic and practical solutions needed for large scale manufacturing.

 

As the industry quickly evolves, we offer technology that robustly scales from the laboratory and is proven to work in industrial processes to reduce your technology transfer risks. Whether you prefer an end to end, integrated platform to reduce development time or just one technology, we have the products, knowledge and services to help you deliver your gene therapy to market.

 

gene therapy process

Your Process, Your Journey

 

Whatever direction your process choices take you in, our range of cell culture, purification and fluid handling technology supports the scalable production of viral vectors such as adeno-associated virus (AAV) and lentivirus (LV).  

 

Our keystone technologies can work on their own, or combine to create robust, but flexible integrated bioprocessing platforms that accommodate your unique processing requirements and accelerate your journey through process development to production. 

 

These preconfigured platforms can also be provided in a prefabricated flexible POD® cleanroom from G-CON to further reduce the time required to arrive at a compliant manufacturing process.

 

 

 

Journey Guidance

 

Beyond our products, Pall Biotech has the knowledge and facilities to support and accelerate your process development. Together we can rapidly optimize your process and prove its readiness for industrial scale production and increase your speed to market.

 

process development services

 

For genetic disease therapy and for oncolytic virus therapy the scalability and flexibility of production at all scales is essential to quickly transition from process development to efficient, full scale manufacturing processes that are fully compliant with cGMP.  This remains true for small and large scale gene therapies and for the creation of working seed stocks of purified virus as required for the ex-vivo cell modification that supports cell therapies such as CAR-T.

 

Our range of fixed bed and suspension culture technology overcomes these processing challenges to simplify your journey from laboratory to an industrial scale and from process development to regulated production.  They combine with clarification, chromatographic purification, ultrafiltration and sterile filtration to deliver a total process solution and can be integrated with single-use fluid handling technology to create closed manufacturing systems that protect both product and operators during production.

 

Cell Expansion and Virus Production

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Single-use, scalable cell culture options support suspension and adherent producer cell lines, cell expansion, viral transfection and virus production. All production systems are designed to maintain a sterile closed manufacturing environment and are automated to assure consistent operation and assure product quality.

 

Adherent Cells

 

One of the greatest challenges facing adherent cell processes is the scale-up to an industrial scale.  Our unique fixed bed bioreactors are capable of simple scale-up maintaining closed system production with a small footprint across all scales.  

 

  • iCELLis® 500+ system for manufacturing scale production (66 m2 to 500 m2)
  • iCELLis Nano for feasibility and small-scale production (0.5 m2 to 4 m2)
  • Xpansion® multiplate system, well suited for seed train operations for the iCELLis bioreactor range. (0.6 m2 to 12 m2)

 

Suspension Cells

 

For suspension cultures, a range of single-use, scalable stirred tank bioreactors and a bi-axial rocking system are available to support cell expansion and vector production at all scales.

 

 

 

Clarification of Harvested Vectors

 

The removal of cells and cellular debris requires the careful application of filters with structures that can retain both large and fine debris while maintaining high yields.  The combination of optimized depth filtration and sterilizing grade filtration assure low particle feed to downstream purification and high virus transmission.

 

 

Purification of Viral Vectors

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The range of robust, scalable purification technologies effectively combine to reduce impurities such as residual plasmid DNA, host cell DNA and empty or partially filled vectors, to deliver the high purity, concentration and potency that you need.

 

Flexible, automated systems for chromatography and ultrafiltration permit the re-use of non product-wetted components and use single-use systems that are quick to install and eliminate the risk of batch to batch contamination.  They can be applied to multiple stages within the process to eliminate cleaning and cleaning validation, minimize capital investment and accelerate batch turnaround times.

 

Chromatography

 

Membrane based ion exchange chromatography delivers high capacity, high purity and can work with single-use, automated platforms for simplified operation and improved process agility.

 

 

Ultrafiltration

 

The diafiltration and concentration of intermediates and final product can be achieved using single-use cassettes and systems to simplify processing.

 

 

Worried about the impact of shear on your sensitive product?  Try our range of single-pass concentration and diafiltration modules and discover how these could revolutionize these operations.

 

 

Sterile Filtration of Purified Vectors

 

The sterile filtration of viral vectors provides a unique challenge and yields can be significantly impacted without careful selection.  Pall’s Supor® sterilizing grade filter capsules balance the assurance of sterility with the high transmission of virions and can be supplied presterilized and as part of a multicomponent system designed to simplify your manufacturing process. 

 

 

The preparation, storage and transfer of media, buffers, intermediates and final drug product requires careful control to prevent contamination and to comply with cGMP.  The efficiencies that can be gained by using single-use solutions are well documented and their use can accelerate process development, simplify manufacturing processes and safeguard quality.

 

Our range of fluid handling technologies can be used as part of a pre-assembled, sterilized system or as components added to existing processes.  They support single-use manufacturing platforms to reduce bottle-necks and are simple to use, reducing process deviations and assuring quality.

 

Sterile connection and Disconnection

 

The addition of fluids to the producer cell culture at all stages of the process including transfection and production as well as secure disconnection of the final product containers demands absolute cleanliness.  Supplied ready for integration with existing process components or supplied as part of a single-use system, Kleenpak® sterile connectors and disconnectors provide an easy to use, secure method of connection and disconnection in flexible tubing assemblies.

 

 

Fluid Handling

 

Single-use technology can simplify the assurance of cleanliness and remove process bottle necks.  From simple fluid transfer sets to mixing solutions that deliver sterile cell culture media or buffer to your process, these solutions streamline production, safeguard cleanliness and simplify operation to support a rapid development of processes.

 

 

Automation and Control

 

Process control, either through manual adjustments, or with the help of automated systems, helps assure final product quality and simplifies production. Our range of control systems and process flow components are designed to integrate with a single-use process to streamline production through the application of optimal design and automation.