June 3, 2015
Volume 11 Issue 6
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In the Lab
Randi Hernandez
New test methods can streamline drug development by bringing safety testing of raw materials directly to the manufacturing floor.
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Stephen Wicks, PhD
The European Pharmacopoeia addresses the need for monographs for biologicals to keep pace with recent analytical technology advances.
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Bioprocessing and Sterile Manufacturing eBook
Pharmaceutical
Technology's Bioprocessing and Sterile Manufacturing ebook examines novel technologies for the development, manufacture, purification, and delivery of small- and large-molecule drugs, including single-use systems, lyophilization, and microbial monitoring. Aging facilities and the future of aseptic processing are featured topics.
Read/Download Now
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New Lab Technologies
Thermo Scientific's TSX ultra-low temperature freezer is designed to lower its impact on the environment with the use of natural refrigerants, using up to 50% less energy than conventional refrigerant ultra-low freezers.
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Telstar's compact steam sterilizing autoclave model is designed with hinged front-facing access panels.
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Waters announces it will introduce its new technology at the 63rd Society of Mass Spectrometry conference.
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Potentiometric titration systems from Metrohm can be customized for different applications.
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The Gyrolab CHO-HCP Kit 1 detects and quantifies host cell proteins from Chinese hamster ovary cells.
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Practical Guidance for Successful Mammalian Cell Banking and Cell Line Characterization
On Demand
Join us for this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to
learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
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Outsourcing Update
Eric S. Langer
While biomanufacturing clusters continue to emerge outside of North America and Western Europe, they are unlikely to threaten these powerhouse CMOs.
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Solubility Enhancement
Solutions Using Predictive Analytics & Molecular Modeling
Live Webcast: Thursday, June 4, 2015 8:00 am PDT/ 10:00 am CDT/ 11:00 am EDT
Learn about a novel, systematic methodology to accelerate solubilization of poorly soluble molecules and speed formulation optimization and process development. Understand how molecular modeling can be used enhance the predictability of solubilization and overcome poor bioavailability.
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API Synthesis & Manufacturing
Cynthia A. Challener
Research groups supported by industry tackle the challenges of continuous crystallization and process analytical technology.
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Agnes Shanley
Despite the buzz about biologic-based drugs, small molecule-based drugs are still the mainstay treatment.
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Stability Assessment for Shipment of API and Drug Products
On Demand
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment.
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Regulation & Compliance
Sean Milmo
A restructuring of the International Conference on Harmonization could change the way pharmaceutical regulations are harmonized worldwide.
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EMA confirms its recommendation to suspend medicines approved based on GVK Biosciences studies.
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Supply Chain Management
Supply chain consortium establishes a working group to address quality problems in India.
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Ashley Roberts
A complex and evolving set of regulations challenges drug manufacturers to understand and implement serialization requirements.
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Contact Services Update
The Denmark facility will incorporate CMC's Bioreactor 6Pack configuration in one manufacturing line.
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SAFC's new ADC wing in St. Louis, MO will feature commercial-scale manufacture of antibody-drug conjugates, and its Carlsbad, CA site will offer enhanced gene-therapy services.
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This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.
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Symbiosis Pharmaceutical Services is now offering a new bulk lyophilization (freeze drying) service in response to increasing demand in the manufacture of bulk intermediates and APIs by lyophilization.
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Clinical supplies facility in Frankfurt, Germany will triple Theorem Clinical Research's current clinical supplies capacity.
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Grand River Aseptic Manufacturing named one of Michigan 50 Companies to watch.
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ProMetic Life Sciences will use manufacturing and plasma fractionation processes at Emergent BioSolutions' Winnipeg, Canada facility.
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Webcasts
Wednesday, June 10, 2015 at 11am ET
In this webcast, experts from BASF will introduce cases that demonstrate the functionality of their excipients and their use in solving problems or meeting design objectives for topical products.
Sponsored by: BASF
Wednesday, June 17, 2015 at 2 pm EDT, 2 pm EDT, 11 am PDT
Join a discussion on the use of hydroxyapatite in mAb and mAb fragment purification processes.
Sponsored by: Tosoh Bioscience LLC
more webcasts
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