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Wednesday, November 26, 2014  |  Volume 6 / Number 24  |  A Production of the BioProcessing Journal
Career Development
CMC Strategy Forum
Japan 2014
December 8–9, 2014
Tokyo, Japan
CMC Strategy Forum
and WCBP 2015
January 26–29, 2015
Washington, DC USA
Phacilitate Washington Bioleaders Forum 2015
January 26–28, 2015
Washington, DC USA
2015 PDA Annual Meeting
March 16–18, 2015
Las Vegas, NV USA
Technical Short Course:
Insect Cell Culture and Baculovirus Expression Vector System
March 31–April 3, 2015
Worcester, Massachusetts USA
Techno-Blast Masthead
Pancreatic Islets

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Suggested Reading
Failure Mode and Effect Analysis (FMEA) as a Quality by Design (QbD) Tool for
Managing Biopharmaceutical Product Development and Manufacturing Risks
By Mark F. Witcher, PhD, Integrated Project Services (IPS)
Products & Services
New Bioreactor Provides Reliable Tissue Growth from a Versatile, Easy-to-Use System

For more information, please visit
Bose Corporation has launched the 3DCulturePro™ system, a new multi-specimen perfusion bioreactor designed for biologists, biomedical researchers, and scientists who require reproducible and reliable tissue growth. The 3DCulturePro system supports cell growth and 3D tissue culture in an easy-to-use, scalable configuration.

Versatile and portable, the 3D CulturePro bioreactor is built for multiple experiment usage, is completely biocompatible, and can be moved in and out of standard cell incubators. It can also be set up as a single, standalone chamber with specimen fixtures or as a complete, multi-chamber system with a perfusion pump.

The multi-chamber configuration can hold up to six chambers, which can be positioned vertically, horizontally or on the side to support various applications and experiments. Each chamber comes with barb fittings, porous platens, and grips that can be used for different sample sizes and types, including bone, blood vessels, skin, ligaments, tendons, or other tissues and biomaterials.
Single-Use Process Container Film for High-Volume Biopharmaceutical Applications
EMD Millipore has introduced PureFlex™ Plus film, a robust, durable film used in the construction of Mobius® single-use process containers for biopharmaceutical manufacturing.

PureFlex Plus film adds a new, more robust linear low density polyethlene (LLDPE) outer layer, which reduces susceptibility to leaks through abrasion, puncture, stretching, and tearing. The inner layers of the film are identical to the original PureFlex film product and offer the same well-characterized extractables profile and gas barrier properties. Because the fluid contact layer is the same in both films, current users of PureFlex film can incorporate PureFlex Plus technology with reduced validation requirements. Original PureFlex film will still remain available.
Similar to its predecessor, PureFlex Plus film is a high purity, medical grade, coextruded film designed to provide strength, flexibility, low gas permeability, and an inert product contact layer. All contact layers are free of animal-derived components and comply with FDA regulation 21 CFR 177.1520. Using EMD Millipore’s EZ fold technology, these flexible films allow for high-volume bag assemblies (> 500 L) to be filled in a bin without operator manipulation or the use of a hoist.

For more information, please visit
Production Capacity Increased by Addition of 100-Liter Single-Use Bioreactor
Kempbio, Inc. has more than doubled its single-batch production capacity in mammalian and insect cell protein expression systems with the installation of a 100-liter, single-use bioreactor (SUB). The SUB is ideal for the production of proteins for animal studies, diagnostic antigens, or for process development runs prior to entering a cGMP facility. This state-of-the-art, single-use technology coupled with Kempbio’s years of experience in large-scale cell culture ensure optimal results for each run.

Kempbio, Inc. is located in Frederick, Maryland and specializes in the production and purification of proteins derived from stable and transient mammalian and insect cell expression systems.

For more information, please email or call 240-629-8924.
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Career Development
The 12th Conference on Protein Expression
in Animal Cells
September 20–24, 2015
San Diego, California USA
EMBO Workshop:
Modern DNA Concepts and Tools for Safe Gene Transfer and Modification
March 30–April 3, 2015
Évry, France
Senior Manager,
Quality Assurance
BPJ Publishing

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