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Wednesday, June 27, 2012  |  Volume 4/Number 13  |  A Production of the BioProcessing Journal

   
Career Development
cGMP Biomanufacturing Operations
July 9-12, 2012
Assay Development and Validation for Biomolecules
July 24-25, 2012
Fermentation Engineering
July 24-26, 2012
All courses take place in: Raleigh, NC USA
Drug Product for
Biological Medicines:
Novel Delivery Systems, Challenging Formulations and Combination Products
Biotechnology & Bioprocessing Summer Training Program
July 18-20, 2012
Lowell, MA USA

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Suggested Reading
Analysis of the BPCIA: FDA Guidelines Concerning the Characterization
of Reference and Follow-On Macromolecules
(The Third of a Three-Part Series)
By Verne A. Luckow, PhD, JD, Polster Lieder Woodruff & Lucchesi, LC
To read the series in its entirety, view Part 1 and Part 2
White Paper: 7 Secrets for Crystallization Development
By Mettler-Toledo
Publisher's Commentary
I'm writing this commentary in anticipation or, more appropriately, dread of the Supreme Court’s rulings on the Patient Protection and Affordable Care Act (PPACA) that is expected on Thursday. And in this vein, our Techno-Blast features an article we highly recommend from Verne A. Luckow, PhD, JD. (See Suggested Reading above).

This is the third in a series of articles Dr. Luckow has written on statutes, regulations, and court cases affecting the intellectual property rights of life sciences institutions. Article III covers aspects of the Biologics Price Competition and Innovation Act (BPCIA) included in the PPACA that could be affected if the Supreme Court rules that specific provisions such as the individual insurance mandate, or the entire law, are unconstitutional. Read more...
Sponsored Link
For Convenient and Secure Sterile Disconnection of Flexible Tubing

The new Kleenpak™ sterile disconnector provides an easy and secure method for the permanent disconnection of flexible tubing while maintaining fluid path sterility before and after disconnection — even in uncontrolled environments. No tools or capital equipment are required, and with a simple 4-step operation, sterile disconnection can be made in seconds, even in cramped environments. Compatible with tubing from ¼-inch to ½-inch ID, the disconnector can be gamma-irradiated or autoclaved and is suitable for use in Class A/100 clean-rooms.

The Kleenpak sterile disconnector is particularly valuable in upstream processing and final formulation & filling applications where both ease of use and reliable sterility assurance are critical. Pall Life Sciences engineer and manufacture state-of-the-art Allegro™ single-use systems with Kleenpak sterile disconnectors for these demanding applications.

For more information, please visit www.pall.com/allegro.
Products & Services
Cell Culture Simplified
Terumo BCT’s Quantum cell expansion system transforms open, labor-intensive manual tasks into a closed, automated, and reproducible process. At the core of this system is an advanced bioreactor with thousands of hollow fibers. Throughout each automated step of the culture process, from loading the cells through harvest, the functionally closed environment remains intact.

The system cultures cells with four primary phases:
  1. System is primed as the nutrients, metabolites, and gases diffuse across the fibers in the bioreactor
  2. Cells are loaded into the bioreactor with approximately
    2.1 m2 of surface area
  3. Media exchange begins with the continuous control of temperature, cell feeding, and waste removal
  4. Cells are harvested with the touch of a button in as little
    as 20 minutes
Lab personnel are allowed a high-degree of customization throughout each of these phases. Key process parameters can be monitored and adjusted to optimize the cell culture.

For more information, please visit www.terumobct.com to watch the system in action.
Versatile Parallel High Pressure Reactor
The Asynt Parallel High Pressure Reactor is a cost effective, lightweight unit suitable for stirred or non-stirred applications. Designed for use in conjunction with a simple benchtop magnetic stirrer or stirrer/hotplate, the reactor is proven in applications including homogeneous and heterogeneous catalysis, hydrogenation, corrosion testing, parallel synthesis, and screening.

The standard reactor is manufactured in 316 stainless steel and offers the user 10 x 30 mL reaction vessels that can be configured to operate at up to 300°C and 100 bar pressure. Systems can also be built to accommodate reaction volumes from 5 mL to 50 L in a wide range of materials including Hastelloy, Inconel, Titanium, and alloy steels.

The reactor is easy to set-up (one simple closure) and has a fail-safe mechanism to protect the operator.

For more information, please visit www.asynt.com or contact Asynt at sales@asynt.com.
  Career Development
Personalized Training Courses: Filtration and Integrity Testing
For details and scheduling, email:
bioprocessresources@hotmail.com
Downstream Processing of Biotechnology Products
September 11-14, 2012
Microbial Fermentation: Development & Scale-Up
October 16-19, 2012
Cell-Based Vaccine Production:
A Hands-on Approach

November 13-16, 2012
All courses take place in:
Logan, Utah USA
BEST QC Microbiology Training
Bioburden, Endotoxin,
Sterility Testing
July 17-19, 2012
Toronto, Canada
BPJ Publishing
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Don't finalize your media plans for 2012 without consulting our media kit!

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Techno-Blast Masthead
A culture of
Madin-Darby Canine Kidney (MDCK) epithelial cells.

Image provided by
Michael W. Davidson,
National High Magnetic
Field Laboratory
,
The Florida State University, Tallahassee.

Email your cell images
to the editor today!