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Biotech

Continuous Processing

Enhanced Performance from Start to Finish.

About Continuous Bioprocessing

Pall has turned continuous bioprocessing theory into reality.

We can now show you the future.

A future built from a solid history of biopharma innovation, where newly developed process steps offer end-to-end performance.

Only Pall has the Continuous Ready products and integration expertise that has made Continuous Bioprocessing a reality.

It enables bioprocessors to achieve the highest product quality, productivity and patient benefit with a dramatically smaller footprint and shorter lead times.

 

   

What is Continuous Ready?

 

The Continuous Ready trademark identifies the Pall Life Sciences systems and consumables that enable the biopharmaceutical industry to adopt Continuous Bioprocessing in the manufacture of modern day medicines.

 

   

THERE’S NO CONTINUOUS WITHOUT INTEGRATING CADENCE SYSTEMS

 

With Cadence Systems, Pall has engineered the essential steps to allow Continuous Biomanufacturing to become reality.

 

   

CELL CULTURE & CLARIFICATION

 

Pall's Allegro™ single-use cell culture technologies make your total upstream process robust and efficient, whether you are growing adherent cells for cell therapy or vaccine applications, or have large volume suspension cell culture requirements.

 

   

PURIFICATION

 

The monoclonal antibodies (mAbs) are captured by Chromatography while the concentration of the HCCF is optimized.

 

FORMULATION

 

The API is prepared in ideal concentration and properties for medication.

 

   

Easing the Transition from Batch to Continuous

In this video, Dr Peter Levison guides you on a tour through Pall Biotech’s Continuous Bioprocessing facilities and groundbreaking, high-tech equipment at the Center of Excellence in Westborough, MA. Hear from senior scientists and product managers who describe how continuous processing and Pall’s huge investment in technology and research is helping bioprocessors making the journey from batch to continuous, to achieve the highest product quality, productivity and patient benefit with dramatically smaller footprints and shorter lead times.

Literature Library

  • What Are The Applications Of Continuous Processing?

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Become Continuous

Become Continuous/Continuous State
Become Continuous/Continuous State
Read more

Pall has a proven track record in batch manufacturing processes where it’s engineering and bioprocessing applications expertise combine with the competitive advantages of the separations and purification portfolio to offer robust process solutions to the industry.

Applications

Biotech Applications
Biotech Applications
Read more

Pall’s Cadence BioSMB platform is the first disposable flow path, continuous multi-column chromatography solution that is fully scalable from the PD laboratory to GMP manufacturing.

The Cadence Acoustic Separator in conjunction with a polishing depth filter will continuously remove cells and cell debris from cell culture in a closed system, without the need for centrifugation or primary depth filtration.

Patented SPTFF (single pass tangential flow filtration) technology enables continuous concentration of the product.

Pall’s new Cadence™ Inline Diafiltration (ILDF) device delivers scalable continuous final ultrafiltration (UF)/DF of drug substance with proven selectivity and low binding attributes.

Cells and particulates from the cell culture are continuously entrained by the standing acoustic wave of the Cadence Acoustic Separator, clarifying the cell culture from the bioreactor. The cell culture fluid passes unimpeded through the system and after a polishing step using a depth filter produces harvested cell culture fluid (HCCF) suitable for purification. 

The Cadence Inline Concentrator eliminates the requirement for re-circulation typically required for TFF, reducing shear damage and time for the processing step and improving quality of the process.    

Pall’s Cadence BioSMB platform provides a highly flexible multi-column chromatography system that delivers high throughput and very efficient media utilization when compared to traditional batch, and other continuous chromatography methodologies. This is achieved through a unique single-use eight column system architecture which enables highly flexible flow configuration through the single-use valve cassette. Additionally, the platform is fully scalable from process development (PD) to commercial manufacture. There are two flow range variants available targeted to Perfusion (Cadence BioSMB Process 80 system) and Batch (Cadence BioSMB Process 350 system) bioreactor based processes.  

The Cadence Virus Inactivation (VI) system is a fully automated system that provides the ability to perform low pH virus inactivation to an incoming elution stream continuously, with minimal operator involvement. The system will collect the elution stream from a Cadence BioSMB Process system, however it can easily process as standalone system or with a batch chromatography system. Automation of the manual operations of elution collection, titration to low pH, hold, titration to high pH and then transfer out. The system comprises of a control unit which attaches to one or two system specific Allegro™ single-use mixers dependent on the application. The specification of the manifolds currently supports 24 hours continuous operation.

Pall’s new Cadence Inline Diafiltration (ILDF) device delivers scalable continuous final ultrafiltration (UF)/DF of drug substance with proven selectivity and low binding attributes.

 

Built with conventional cassettes in Delta regenerated cellulose or Omega™ polyethersulfone membrane, the preconfigured, holder-less modules enable removal factors of ≥ 3-log, with a single pass through the device. 

Cadence™ Inline Diafiltration Module

Pall’s new Cadence™ Inline Diafiltration (ILDF) device delivers scalable continuous final ultrafiltration (UF)/DF of drug substance with proven selectivity and low binding attributes.

 

Built with conventional cassettes in Delta regenerated cellulose or Omega™ polyethersulfone membrane, the preconfigured, holder-less modules enable removal factors of ≥ 3-log, with a single pass through the device. 

 

Resources

Resources (PDFs and weblinks)
Resources (PDFs and weblinks)
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Learn the findings of the full-factorial modeling exercise

Understand the cost benefits of continuous bioprocessing at many scales of manufacturing.

Watch
  • Learn how to implement Quality by Design (QbD) principles, and process validation strategies for continuous virus filtration
  • See the process inputs that should be evaluated to determine critical process parameters
  • Learn how a Pegasus™ Prime virus filter achieves high virus retention and delivers a robust and efficient continuous process
Watch
  • Learn how to reduce facility footprint, capital expenses and product cost-of-goods
  • See how you can improve your process productivity, flexibility, and further facilitate the utilization of single-use and/or disposable technologies
     

Continuous bioprocessing for biologics manufacturing is being adopted in the biopharmaceutical industry. Pall Life Sciences has brought several innovative technology platforms to the market to address the opportunities for Continuous Bioprocessing. In this webinar, Pall’s development journey in continuous bioprocessing will be introduced along with highlights of recent technology advances and product introductions for both PD and GMP operations.

Watch

We address optimal configuration of a multi-column continuous chromatography (MCC) system, with insight into the impact antibody titer has on the number of chromatography columns required to optimize productivity of a MCC process.

MCC  has been gaining increasing interest as an enabling bioprocessing technique that allows for increases in specific productivity (g/L/hr) and operating binding capacity (g mAb/L sorbent) over traditional batch solutions. With recent advances, users have reported an increase in cost savings stemming from reduced resin volumes, lower buffer consumption, and increased resin usage.
 

Mark Pagkaliwangan presents, with David Johnson moderating, as they discuss MCC solution advances with processes utilizing two columns or more. They will explore how the total number of columns used in a process can affect performance, and how titer and flowrate can be optimized with more columns for greater efficiency and productivity.

Watch

Our team will examine common regulatory challenges and areas of uncertainty in the implementation of continuous bioprocessing, and suggest practical, total solutions.

Many industries have adopted a one-piece flow approach (continuous manufacturing) to leverage the core reductions in inventory, increased operational flexibility, and greater product consistency and quality that it delivers. However, biopharmaceutical manufacturers have been slow to put continuous processing theory into practice due to the highly-regulated nature of the industry.

In this webinar,  Peter Levison, PhD will moderate as Mani Krishnan, PhD and Marc Bisschops, PhD examine the evolution of interest in continuous bioprocessing, the advances being made in today’s market, and how the regulatory authorities are responding. Mani will also offer insight into the technological challenges of implementing continuous bioprocesses, and potential regulatory questions surrounding batch definition, bioburden control, virus clearance, scale-up/down, defect perturbation, design space, etc. He will also propose effective mitigation strategies for a successful transition to continuous bioprocessing.    

Watch

A review of simplified continuous filtration, particularly for UF/DF, with a look into our exclusive licence to patents in the field of single-pass tangential flow filtration (SPTFF), which enables continuous filtration without recirculation at several stages of a continuous bioprocess. ​​


Single-pass tangential flow filtration (SPTFF) technology from Pall Life Sciences is a versatile concentration approach for biotech, vaccine and plasma industry applications. Patented Cadence™ SPTFF technology offers a total solution for inline volume reduction and/or concentration, in-process dilution/de-salting, high concentration formulations, and processing of fragile molecules, crucially enabling integrated, streamlined and continuous bioprocessing initiatives.

In this webinar, moderator Kevin Marino and presenter Jon Petrone provide an overview of SPTFF technology, including case studies where this novel technology was applied to enhance processes and reduce bottlenecks in production.

Watch
  • How a continuous Protein A chromatography process step using KANEKA KanCapA sorbent for the capture of a therapeutic mAb was developed and achieved in less than four weeks, and the related process economic benefits    
Watch
  • How to apply continuous multi-column chromatography practically
  • How continuous technologies can dramatically lower the cost and complication of this key purification step    
Watch
  • See an industry-leading single-use portfolio which is delivering innovative continuous bioprocessing solutions
  • The development journey and critical advances to date in continuous bioprocessing
Watch
  • The evolving nature of continuous bioprocessing technologies
  • Scalability solutions
  • Practical applications and methodologies of continuous bioprocessing systems
  • Decreased costs, smaller operational footprint, and improved asset utilization are invaluable benefits
Watch

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