The new and improved iCELLis 500+ bioreactor system will simplify large scale cGMP production of virus for vaccines or gene therapy. New features provide enhanced robust control, reliability, and sustainability of high-density adherent cell growth in an automated format.

 

Boasting a new stainless steel frame and temperature control unit (TCU), the iCELLis 500+ bioreactor is fully compatible with 21 CFR Part 11 standards and cleanroom requirements.

 

It features an integrated recipe manager, improved tubing management, and a new temperature control unit (TCU), enabling greater process control, faster filling and draining, and further automations of customer processes for cell and gene therapy and vaccines. 

Single-pass tangential flow filtration is revolutionizing how tangential flow filtration is implemented in biotech, vaccine, blood plasma and other applications. Pall has now made it even easier to implement this breakthrough patented technology into your process. As with the original Cadence SPTFF modules, the Cadence Inline Concentrator (ILC) is now available with Omega™ polyethersulfone membranes and allows direct flow through in-process volume reduction and can be implemented into a process system or operated as a standalone unit.

 

This exciting technology leads to economic and practical benefits, including:

 

- Ability to couple the concentration of product before or after other downstream processing (DSP) steps, consequently optimizing other steps and reducing in-process pool tank volumes

- Continuous processing in DSP

- Easy integration of the assembled module, allowing plug-and-play

- Potential reduction of product damage or aggregation due to reduced residence time and shear exposure

The Allegro™ STR 50 L bioreactor maintains direct scale-down engineering design concept from the Allegro STR 200 L bioreactor, while leveraging usability and process assurance features that have differentiated Pall’s Allegro STR bioreactor product range from all others in the single-use stirred tank bioreactor market.

The new iCELLis Nano bioreactor system is designed to make process development and small scale production of virus for vaccines or gene therapy easy and straightforward. In addition to being compatible with the mPath control system, the iCELLis Nano bioreactor now has a redesigned docking station which integrates perfusion, improves heating, and adds a variety of ease-of-use features.

A loss of integrity of a single-use system (SUS) during commercial manufacturing can lead to drug contamination or operator safety concerns. Therefore, assurance of integrity of SUS has become a hot topic in our industry and the need for very sensitive integrity tests at SUS suppliers has arisen. The Pall Helium Integrity Test (HIT™) system for Allegro™ 2D SUS is a cutting-edge supplier integrity test for SUS implemented in critical processing steps of drug substance or drug product, to enhance patient safety. This test can detect down to 2 µm defects in SUS.

Designed specially for biotech drug manufacturers to benefit from the most compact filter installations when protecting unit operations from microbial and particulate process fluid contaminants, Mini Kleenpak™ filter capsules with Supor® EX grade ECV filter media are ideal for process development and manufacturing where fluid volumes are in the region of 2 to 50L (fouling properties dependent).

Delivering continuous processing for the final ultrafiltration (UF)/DF of drug substance and constructed with conventional tangential flow filtration (TFF) cassettes in Delta regenerated cellulose or Omega™ polyethersulfone membrane, the device ensures accurate scalability, proven selectivity and low protein binding attributes. Preconfigured, holder-less modules include a tubing set that connects to a feed pump and DF buffer pump for simple operation, enabling removal factors of ≥ 3-log with a single pass through the device.

A robust solution for the economic clarification of monoclonal antibody cell cultures without centrifugation or process additives. The single-use harvesting platform features a 4-layer concept, and has been optimized to maintain performance as cell density and viability change to minimize the impact of process variability between batches. Media configurations are available in many formats to scale directly from bench-top testing up to large-scale clinical production.

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.

The next generation in simplified single-use biomanufacturing, this new system with the innovative mPath™ controller provides a benchtop solution ideal for applications ranging from the process development laboratory to the full-scale cGMP production suite. Pall’s new Allegro XRS 25 system couples the Allegro 3D biocontainer with a unique ’bi-axial‘ agitation mode that creates more efficient mixing, leading to superior cell culture performance: higher cell densities and viabilities, and increased total product titer. Thoughtful industrial design and special biocontainer and system features ensure operational simplicity, superior robustness and maximizes ease-of-use.

The mPath™ bioreactor control system is an expandable control and data management system including both bioreactor control towers and an advanced supervisory control and data acquisition (SCADA) software package. Designed with a strong focus on ease of use, the system includes usability features such as biocontainer hangers with integrated load cells and mobile interfaces to modernize and simplify workflow. Features support characterization, optimization and GMP manufacturing providing a strong compliment to the Pall range of bench scale single-use bioreactors. The mPath bioreactor control systems will soon be available with the XRS 25 bioreactor, with further bioreactors launching through the end of the year.

Introducing the jacketed 200 L Allegro™ STR bioreactor, a direct scale-down bioreactor of the 1000 and 2000 L STR, all supporting a wide spectrum of demanding cell culture applications including those requiring stringent controlled heating and/or cooling. The Allegro STR bioreactor family combines Pall’s bioprocess engineering expertise, cell culture know-how and our drive for quality into a series of single-use bioreactors that deliver consistent and scalable cell culture performance across the range. The Allegro STR bioreactor family has a direct bottom-driven impellor allowing power inputs up to 0.25 W/kg, resulting in high oxygen transfer rates and short mixing times.

An easy-to-use genderless technology for the sterile connection of two fluid paths even in uncontrolled environments. Available in sizes ¼ in., ⅜ in., ½ in. and ⅝ in. hose barb and ½ in. sanitary connection, these devices made from Bisphenol-A free polyethersulfone allow end users to use it in a broad range of applications. 100% inspection of each device linked to device serial numbers gives even greater levels of quality assurance.

Providing robust virus retention to protect critical manufacturing bioprocesses, assure drug quality and safeguard health, these gamma irradiated cartridges and capsules combine high flow and robust capacity, to simplify your process and deliver sustainable economy at all scales. The flow, filter capacity and virus retention established during small scale filterability and virus validation studies scale to a range of products to support your process and offer the highest degree of manufacturing control, flexibility and security.

Pall continues to improve cell culture with the launch of the 2000 L single-use bioreactor with working volumes of 400 to 2000 L. The Allegro STR bioreactor family combines Pall’s bioprocess engineering expertise, cell culture know-how and our drive for quality into a series of single-use bioreactors that deliver consistent and scalable cell culture performance across the range. The Allegro STR bioreactor family has a direct bottom-driven impellor allowing power inputs up to 0.25 W/kg, resulting in high oxygen transfer rates and short mixing times.

Single-pass tangential flow filtration has revolutionized how TFF is implemented in biotech, vaccine, blood plasma and other applications. The Cadence modular kit provides additional functionality to the standard SPTFF product offering for the biopharmaceutical industry by enabling the product/technology portfolio to be used with any type of membrane and cassette format that Pall currently offers. It provides the flexibility that is needed to perform with today’s challenging applications.