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Techno-Blast
Wednesday, August 30, 2017  |  Volume 9 / Number 18  |  A Production of the BioProcessing Journal
ISBioTech 5th Fall Meeting
Career Development
PDA/FDA
PDA/FDA Joint
Regulatory Conference
September 11–13, 2017
Washington, DC USA
CASSS
CMC Strategy Forum
Latin America
October 9–10, 2017
Mexico City, Mexico
Phacilitate
Phacilitate Cell & Gene Therapy Europe
September 19–21, 2017
Berlin, Germany
ESGCT
XXV Anniversary Congress
October 17–20, 2017
Berlin, Germany
4th International Workshop on Statistical and Data Management Approaches for Biotechnology
Drug Development
October 30–
November 1, 2017
Rockville, Maryland USA
ISBioTech 8th Spring Meeting
Suggested Reading
Quality Risk Management (QRM):
Part III — An Approach for Understanding and Either
Accepting or Mitigating the Results of a QRM Analysis
By Mark F. Witcher, PhD, NNE
Products & Services
Unique Alternative to Animal Testing in the US
Genoskin
Genoskin announces its expansion into North America with the establishment of an office in Boston and plans to open a local production unit in the first quarter of 2018. Genoskin provides a unique alternative to animal testing using excess human skin that is donated by patients after common plastic surgery procedures. The retrieved tissue is placed in a testing well that contains a special biological matrix to keep the skin alive for several days.

As animal tissue differs from human tissue in many aspects, a large majority of the drugs that are validated on animals during preclinical studies will never reach the market, mainly due to toxicity and efficacy issues in humans. Unlike animal skin, bioprinted skin, or skin grown in laboratories, Genoskin provides real, live human skin to study drug and compound toxicity and efficacy on a model that is as close as possible to in vivo.

Genoskin has started a fundraising campaign and is open to industrial, financial, and academic collaborations to boost its US expansion. For more information, please visit genoskin.com.

New Aseptic Fill Finish Line
Ajinomoto Althea, Inc. ("Althea") announces the installation and launch of a new high-performance sterile vial filling line. The new Optima VFVM 7000 aseptic fill finish line further strengthens Althea's drug product manufacturing capabilities and supports a broad range of drug substance APIs compatible with both peristaltic and rotary piston pump filling systems.

This new filling line expands Althea's current capabilities by enabling larger batch sizes and a broader range of filling volumes (0.2 mL up to 100 mL). It also significantly reduces product loss, thus preserving costly API. The state of the art equipment also provides 100% in-process control, nitrogen purging, and several additional features to maximize yield. For more information, please visit altheacmo.com.
Optima VFVM 7000
Consortium Formed to Develop an Automated Continuous Purification Unit

The Centre for Process Innovation (CPI) is participating in a consortium to develop an automated continuous biologics purification unit for more efficient manufacture of a wide range of biologic drugs. This project brings together five leading biopharmaceutical companies with UK operations, process technology suppliers, and CPI’s National Biologics Manufacturing Centre. The new unit will consist of integrated, multiple operations running concurrently.

The biopharma industry will increasingly need to find new ways to maintain competitiveness by ensuring affordability, quality, and delivery performance. Continuous processes have been proposed as a solution as they are scalable, offer higher productivity with reduced running times and materials usage, and require a smaller footprint and less capital intense facilities. In addition, automated continuous bioprocesses minimise human intervention and thus the potential for errors.

Centre for Process Innovation

The consortium’s participating organisations are Pall Europe Ltd, CPI, Allergan Biologics Ltd, Fujifilm Diosynth Biotechnologies UK Ltd, Medimmune Ltd, and GlaxoSmithKline PLC. The consortium is funded by Innovate UK, and all lab work will be completed at CPI facilities using equipment provided by Pall and feedstock from the manufacturers in the consortium. For more information, please visit uk-cpi.com.

Career Development
BioPlan
14th Annual Report
and Survey of Biopharmaceutical Manufacturing Capacity
and Production
ESACT
Courses
Cell Culture-Based Viral Vaccines Course
Second Edition
September 19–22, 2017
Animal Cell Technology Course
Seventh Edition
September 24–28, 2017
Llafranc, Costa Brava, Spain
PEACe
13th Conference on Protein Expression in Animal Cells
September 24–28, 2017
Valencia, Spain
BPJ Publishing
BioProcessing Journal Open Access
Techno-Blast Masthead
Dendritic caps
(confocal micrograph).
Courtesy of Thomas Moninger, Assistant Manager, University of Iowa's Central Microscopy Research Facility. Used under permission.
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