Forward
Wednesday, October 14, 2015  |  Volume 7 / Number 21  |  A Production of the BioProcessing Journal
Career Development
ISPE Annual Meeting
November 8–11, 2015
Philadelphia, Pennsylvania USA
CMC Strategy Forum
Japan 2015
November 9–10, 2015
Tokyo, Japan
WCBP 2016
January 26–28, 2016
Washington, DC USA
Phacilitate
Washington 2016
January 25–27, 2016
 Washington, DC USA
ASGCT 19th Annual Meeting
May 4–7, 2016
 Washington, DC USA
7th Monolith Summer School and Symposium
May 27–June 1, 2016
Portorož, Slovenia
Techno-Blast Masthead
HeLa cells were co-transduced with CellLight® Tubulin-GFP (cytoskeleton, green) and CellLight® Mitochondria-RFP (red). Nuclei were counter-stained with NucBlue® Live cell stain. Images were acquired on an EVOS® FL Auto imaging system with a 100X oil-immersion objective.

Courtesy of
Thermo Fisher Scientific
.

Email your cell images to the editor today!
Suggested Reading
The Use of Signal Filtering Algorithms in Bioreactor Characterisation
and Monitoring Using Raman Spectroscopy
By Giuseppe Elia, Sanofi; and Dylan Jones, Matthew Harding, and Chris Whitmore
Sponsored Link
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Products & Services
Cell History File Designed as ‘Cell Passport’ for Tissue and Cell-Based Products
The Cell Therapy Catapult announces the availability of the Cell History File (CHF) template document. The CHF template has been developed in conjunction with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), the Human Tissue Authority (HTA), and other cell therapy developers and manufacturers from academia and industry.
The non-mandatory document has been designed for all organisations involved in the procurement, testing, processing, storage, and distribution of human cells and tissues for human application and/or therapeutic use. These could be for either autologous or allogeneic use and could also include a cell banking step.

The CHF has been designed to fulfill the role of a ‘cell passport’ that can accompany a tissue or cell derived product as it progresses through various processing stages. The CHF is flexible to suit the individual requirements of developers, but can provide a structure for key information to be collected and contained in a single source. This will include key traceability and manufacturing information required by EU Directives and HCT/P in the US, and is also complementary to other EU regulatory documentation.

The CHF template document is available on the Cell Therapy Catapult website. For more information, please visit ct.catapult.org.uk or www.gov.uk/innovate-uk.
High-Speed Quantification of Immunoglobulin G
BIA Separations introduces the second generation CIMac™ r-Protein A Analytical Column. This short bed, high-performance monolithic column is primarily intended for fast, efficient, and reproducible qualitative and quantitative analyses of immunoglobulin G (IgG), and is suitable for use with HPLC and UPLC systems.

The CIMac r-Protein A Analytical Column is the chromatographic tool of choice for in-process (PAT) and final control of IgG purified from cell culture supernatant or human plasma. Quantification of IgG is possible between 0.20 µg and 20 µg. The column's small volume and short length allow operation at high volumetric flow rates (up to 3 mL/min). The column also has an innovative, symmetrical design for bi-directional flow to extend its lifetime. Information on product quantity and purity is generated in just 1 minute.

To test the column at the special launch price, valid within the next six months, contact sales@monoliths.com.
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Career Development
Free Webinar:
Low Endotoxin Recovery (LER) – Context and Resolution from a Broad Biologics Test Perspective
October 20, 2015 and
October 21, 2015
2nd Progress and Challenges in Protein Particles and Immunogenicity of Biotherapeutics 2015:
Filling in the Gaps in Risk Evaluation and Mitigation
November 12–13, 2015
Rockville, Maryland USA
HPLC 2016—44th International Symposium on High Performance Liquid Phase Separations and Related Techniques
June 19–24, 2016
San Francisco, California USA
PREP 2016—29th International Symposium on Preparative and Process Chromatography
July 17–20, 2016
Philadelphia, Pennsylvania USA
BPJ Publishing






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