Bioprocess Vision - Issue 4 - March 2013

Regional Versions (PDFs):

Market Trends

Improved Bioreactor Design for Laboratory to Production Suite Operations

XRS 20 Bioreactor systemBiotech manufacturers today are rapidly adopting singleuse technologies for almost every unit operation in the manufacturing process. Upstream cell culture fermentation operations are no exception; manufacturers are increasingly moving the first generations of single-use bioreactor systems from the R&D facility into pilot scale and full production scale facilities. As these systems are more widely used, shortcomings in robustness, productivity, and overall ease-of-use are receiving more attention.

Bioreactor systems offer challenges from the ease-of-use and robustness perspective. These systems are almost unique in biotech operations in the requirement to integrate moving parts (the agitation system), multiple parameter process measurement and control, and multiple gas/fluid for additions/withdrawal - all into a single-use biocontainer that is easy to install, and maintains 100% fluid/ gas integrity during the expected service life in use.

Recognizing the need for a "next generation" of high performance single use bioreactor systems, Pall Corporation is working to bring to market new bioreactor designs for a variety of single-use upstream applications. The first product, the XRS 20 Bioreactor system, is a rocker style bioreactor designed for seed trains, small scale GMP operations, and general laboratory needs where high capability control systems are required. The XRS system improves on existing rocker-style bioreactor designs with 2 axis rocking, creating a three-dimensional swirling motion for improved agitation and superior oxygen transfer to the cultures.

For more information about this new system, please contact your local Pall representative, or contact

Product News

Single-Use Filling Needles

AllegroTM single-use filling needlesNo more washing and reusing stainless Label-Free Analysis steel needles and performing associated validation. No more having to throw away stainless steel to avoid the risk of cross contamination. Allegro™ single-use filling needlesare a robust, fully qualified engineered plastic alternative that matches or exceeds stainless needles in precision and fill accuracy. By pre-assembling into single-use filling manifolds that can be supplied sterile (by gamma irradiation), attaching tubing to needles in the confines of an isolator and maintaining sterility during connection becomes a thing of the past. A pyrogen-free & endotoxin claim (per USP 85) and a particle release claim (USP 788) is unique to the Allegro single-use filling needle.
  • Only commercially available needle that can be autoclaved & gamma irradiated
  • Fully biocompatible materials; meet USP <87> and <88> for Class VI-121 °C plastics
  • Full traceability, each needle labeled with part number and batch number
  • Suitable for a broad range of filling volumes
  • Lumen diameters of 0.8, 1.6 or 3.2 mm
For further information visit the Allegro™ Single-Use Filling Needles product page.

Salt Tolerant Anion Exchange Chromatography Sorbent

HyperCelTM STAR AX chromatography sorbentThe new HyperCel™ STAR AX chromatography sorbent is a versatile, high productivity anion exchange sorbent that maintains high protein binding capacity with various diluted or non-diluted biological feedstocks. It can be used for capture, purification or polishing of proteins from cell culture, bacterial fermentation, plasma or other feedstock.

Based on the industry-proven HyperCel matrix, the new sorbent provides:
  • Efficient protein capture with feedstock conductivities of 2-15 mS/cm for high flexibility
  • Superior dynamic binding capacities at 1-2 min residence time for high productivity
  • Better process economics to eliminate unit operations like UF/DF or dilution
  • Easy packing/unpacking and cleaning in place (1 M NaOH)
For further information visit the HyperCel™ STAR AX product page.

Octet from ForteBio: A Leader in Real-Time No more washing and reusing stainless Label-Free Analysis

Octet systemForteBio, a Division of Pall Life Sciences, develops and manufactures analytical systems to provide rapid, real-time results for protein quantification or characterization of bio-molecular interaction providing information on affinity, kinetics, and concentration in a wide variety of applications.

ForteBio utilizes proprietary Bio-Layer Interferometry (BLI) and ready-to-use Dip and ReadTM disposable biosensors to measure concentrations and kinetic rates of critical samples, even in crude media, in a cost effective format. An entire analysis can be completed on the Octet system within minutes. ForteBio's analytical capabilities provide greater value in applications where existing methods such as HPLC, ELISA, and SPR have limitations in throughput, performance, and cost.

ForteBio is now recognized as an important enabler in major pharmaceutical, biotech and academic research departments. Greater than 500 systems and 5 million Dip and Read biosensors have been shipped signifying rapid adoption of BLI based label-free tools.

For further information visit Octet® RED384 and Octet QK384 Systems product page.


New member of the Seitz® filter family

SUPRAcap 50 depth filter capsulesSUPRAcap 50 depth filter capsulesrepresent an important addition to the SUPRAcap capsule range and enable reliable scalability for the successful product transfer from R&D through pilot scale and on to full scale production. SUPRAcap 50 capsules incorporate the same design principles as the larger scale depth filter formats like SUPRAdisc™ and Stax™ and feature the same patented inside-outside flow design.
  • Identical flow resistance
  • Identical flow path configuration
  • Full utilization of the entire filter area
These attributes utilized in small bench scale evaluation will allow for even further improved scalability in depth filtration. Supported by tightly controlled media manufacturing to ensure reliable results each and every time comparable to larger scale SUPRAcap and Stax capsules, the new SUPRAcap 50 capsules will make for a perfect start into your new filtration project.

For further information visit the Supracap™ 50 Depth Filter Capsules product page.


Processing Alternative Growth Supplement For Human Cell Culture Using Allegro Single-Use Systems

Mariluz Henshaw Research Scientist University of Utah Processing alternative growth supplement for human cell culture using Allegro Single-Use Systems

As part of the Cell Therapy and Regenerative Medicine Program at the University of Utah, a project was initiated to develop a wellcharacterized human platelet lysate (PL) for use as a commercial cell culture media supplement. The availability of such a supplement is critical to manufacturing of clinical-grade human mesenchymal stem cells (hMSC). University of Utah worked with Pall Life Sciences to develop a fully closed filtration system with associated biocontainers for batch processing, with the objective to maximize the preservation of growth factors while removing precipitates resulting from freeze-thaw lysis of the platelets.

What were your considerations for selecting Pall Life Sciences as a supplier for this project?

Pall provided a collaborative team approach. Product availability is key, but the service and support are just as important.

How did you go about evaluating different filter types?

Pall's filtration experts looked at turbidity and throughput to evaluate the filters' performance, while we tested for growth factors. The optimal filters were then incorporated into a closed single use (SU) system for PL processing that was custom designed by Pall's team of experts. This consisted of a pooling bag, the filtration train, a collection bag for the filtered product and a series of sampling bags for product redistribution.

How did the flexibility of Pall's Allegro biocontainers, Kleenpak™ filter capsules and tubing sets meet the requirement of a closed, ready-to-use system?

The scalability of Pall products allowed us to do our validation runs at a smaller scale without need for any further process development work. Custom design of the tubing sets allowed us to overcome process limitations. Linking subsystems using Kleenpak sterile connectors provided a simple way of maintaining sterility during product transfers.

What validation and technical support is essential to you?

Pall's technical team's understanding of our process objectives enabled good engineering and design. We had tremendous support from early process development through completion of the process validation runs.

The extent of the help and assistance far exceeded my expectations.

Following preparation using the Allegro systems, how did the resulting culture media supplement perform in growing your target cell type?

The average hMSC growth over three validation runs with the filtered PL supplement retained 90% of the activity, compared to unprocessed PL material. This is the first step to having a commercially available well-characterized PL product. We anticipate a growing need to manufacture clinical-grade hMSCs, so availability of PL will be critical in the process.

Internet Highlights

In the current climate of improving manufacturing efficiencies, Pall Life Sciences recognizes the importance of keeping you informed on the latest industry issues, trends, and innovations and now offers you the opportunity to participate in a series of scheduled and on-demand educational events, either on location or via the web. Select from a variety of seminars, exhibits, and webinars that best meets your needs today!

Biopharmaceutical Webinar Series
Detailing the latest industry trends and providing updates on new technologies, the Biopharmaceutical Webinar Series is both educational and engaging. The presentations are given by biopharmaceutical industry leaders and experts. Have you missed one of our live webinars? Not a problem. Please visit for more information and to register for upcoming and on-demand webinars.

Future emails will notify you of upcoming single-use related topics specific to upstream, downstream, and filling operations. Webinar topics will be announced several weeks in advance of their live dates. To sign up for our mailing list, please visit

Biopharmaceutical Seminar Series
Interactive discussions, and presentations, state-of –the- art leading technologies and expertise from upstream cell culture through downstream purification to formulation and filling, our Biopharmaceutical Seminar Series is a great opportunity to stay informed in the diverse and rapidly expanding biopharmaceuticals market. Pall invites you to choose from a variety of seminars that will help educate, support and inspire you to achieve your goals at no cost to you and when it is most convenient. Please visit for more information and to register for a pre-scheduled event or submit a request for Pall to visit you...

Discover your Future... Today! is a series of one-day scheduled seminars offering you a unique chance to hear from regional opinion leaders in biotechnology on key issues and find out how the latest technical innovations can improve both the efficiency and quality of your laboratory scale processes. Currently being offered in Europe

Technology Showcase delivers a diverse portfolio of products, services, and technical expertise from the laboratory to production on-site at your location on the day and time that is most convenient for you and your teams. The flexibility of this event is designed to meet your specific needs without the time and cost of leaving your facility. Available Globally

Think Flexibly is a special day of informative modules, demos and discussion to provide an overview of the latest developments in single-use technology. Our experts will be available to help you address processing issues and discuss how to best perform validation of single-use systems. Currently being offered in Europe and the Americas

For further information on our webinars and seminars, please contact