North & South America

Our representatives

Our representatives located in the West, Midwest, Northeast and South regions of the United Statesare dedicated to providing customers with on-site support and solutions unique to their processes based on our expertise in virus removal filtration and bioprocessing.

Audit reports for Planova manufacturing facilities are now available for purchase from Rx-360, an international pharmaceutical supply chain consortium. Please follow the links below to purchase the reports.

•    Audit Report for Planova Plant (located in Nobeoka-shi, Miyazaki, Japan):
    http://rx-360.org/audit-program/asahi-kasei-medical-co-ltd-ja-800/

•    Audit Report for Planova Oita Plant (located in Oita-shi, Oita, Japan):
    http://rx-360.org/audit-program/asahi-kasei-medical-co-ltd-ja-801/

More information can be found here.

Research and development facility in Glenview, Illinois, USA

Photograph01

The regional head office for North and South America in Glenview, Illinois has developed a state-of-the-art research and development facility to support and collaborate with users of Planova™ filters in the Americas and throughout the world.

Phage laboratory and filtration suite

The phage laboratory is a Biosafety Level 2+ facility held under negative pressure and features a biological safety cabinet for maximum safety when working with the BSL2 host agent, Pseudomonas aeruginosa.

Phage laboratory capabilities

  • Scalable phage production process
  • Capacity for producing hundreds of milliliters of high-titer PP7 stock
  • Filtration setups available at our facility for small-scale phage clearance studies with automated pressure and throughput data collection
  • Phage log reduction value (LRV) results available in 1 to 2 days

PP7 bacteriophage as a model for mammalian virus filtration

Bacteriophages provide unique systems for evaluating virus removal in filtration processes. Structurally similar to mammalian viruses, bacteriophage stocks can be produced with significantly higher titers and require shorter assay time.
PP7 phage is small, non-enveloped, and infects the bacterial host P. aeruginosa. Based on its size and shape, PP7 phage is an excellent model for small, non-enveloped viruses such as parvoviruses.

 

Porcine parvovirus(PPV) *

Porcine parvovirus(PPV)

PP7 phage *

PP7 phage
Diameter (nm) 18 - 26 23 – 28
Surface Non-enveloped Non-enveloped
Shape Icosahedral Icosahedral
Stock titer (log PFU/mL) 8 - 9 10 - 11
Infectivity assay time (days) ≥10 1

*From the VIPERdb website, http://viperdb.scripps.edu/

Phage clearance study on Planova™ filters

The following clearance study data using 5 g BSA/L feed spiked with 0.1% PP7 on Planova™ 15N, 20N, and BioEX filters demonstrate the suitability of our PP7 phage stock as a model for PPV.

  • Minimal flux decay, indicating the clarity of the stock solution
  • Comparable, high removal based on high load titers and LRV
  • Monodispersion of PP7 phage particles, as indicated by the lack of removal on Planova™ 35N filters
hage clearance study on Planova™ filters

Flux decay for PP7 spike (0.1% ) in 5 g BSA/L

Filter Load titer
(log PFU/mL)
Permeate titer
(log PFU/mL)
PP7 LRV
Planova™ BioEx 7.41 ≤0.78 ≥6.64
Planova™ 20N 7.60 ≤0.78 ≥6.82
Planova™ 15N 7.72 2.68 5.03
Planova™ 35N
(aggregate removal)
7.48 7.62 -0.15

Additional services available at Glenview, IL

The Glenview, IL regional head office is also home to Asahi Kasei Bioprocess equipment manufacturing operations. Bringing these resources together provides opportunities to expand Planova™ filter studies to include large-scale control and automation strategies.

Local expertise

  • Consultation on Planova™ filters suited to your process and scale
  • Viral clearance validation support
  • Regulatory compliance guidance
  • Downstream process development
  • Integrated equipment and automation services

Experimental and investigational capabilities

  • Small-scale process optimization and support studies
  • Process scale-up: lab to manufacturing scales
  • Large-scale filter post-use integrity testing
  • Manufacturing-scale phage clearance studies
  • Automated strategies for controlling enhanced filtration processes such as filters-in-series
  • Large-scale integrity testing studies using the Asahi Gold Particle Test System (AGPTS)
  • Large-scale capacity studies using the Virus Filtration Controller (VFC)
Photograph02
contact us

Please make sure to have cookies activated before login!

E-mail address
Password
  •  Workshop 2017 - Prague
  •  Workshop 2016 - Philadelphia
Top of page