Newsletter | July 14, 2014

07.14.14 -- Analytical QbD At Teva; Deploying Smart Process Sensors Sensibly

Bioresearch Online Newsletter

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November 10 and 11, 2014 | Hyatt Regency, San Francisco, CA

Who should attend? Pharma and biopharm executives who form and manage outsourcing partnerships.
What's on the agenda? Educational sessions focused on best practices and industry leaders’ experiences and lessons learned to help you avoid costly mistakes.

Register today! Space is limited. Brought to you by Life Science Leader magazine, BayBio, and Outsourced Pharma.

Featured Focus

Analytical QbD At Teva: Knowledge Is Power Only When You Share It
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
Rosario LoBrutto is currently senior director, head of development, parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk-management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.

Featured Content

Article: Deploying Smart Process Sensors Sensibly
By Amber Ratcliff, Analytical Sensors Market Segment Manager, Hamilton Company
Today's demanding biopharmaceutical manufacturing operations require careful control of process conditions, whether during cell culture, purification, or drug product formulation. Process sensors play a critical role in enabling high-performance manufacturing by providing real-time visibility into how a process attribute is changing, as well as the ability to correlate that change with the stage of the process.


Application Note: Comparison Of The Efficacy Of Various Yeast Viability Stains
By Stephen E Szabo, Ph.D., Manager Applications Development, Beckman Coulter, Inc
Yeast are single-cell microorganisms that reproduce by budding. A well-known property of yeast is that they are responsible for the conversion of fermentable sugars into alcohol and other byproducts.


Case Study: Citation Clinical Labeling Systems Automates For Perfection
By Global Vision Inc.
Today, more and more later-phase global studies demand an incredibly high level of accuracy. The process requires varying dosages amongst diverse patient populations in multiple countries, each with their own set of regulations.


Case Study: Comparison Of Five Cell Culture Media Demonstrating CHO Cell Culture Growth In Batch Or Fed-Batch Process For Commercial Operations
By Mark C. Arjona, Evan R. Horowitz, Alex A. Jurisch, Jenny Y. Bang, Tom Fletcher, Irvine Scientific
This case study details a two-month, four-phase project to design chemically defined feed media that improved two simulated batch processes utilizing products by SAFC, Life Technologies, Thermo Fisher Scientific, and Irvine Scientific.

Industry News

Envirotainer Receives Full FAA Approval For The RKN e1 Container
Protein Sciences' Flublok Vaccine 2014/15 Formulation Approved By FDA
JH Team IDs Genetic Variant Linked To Schizophrenia Risk
BioMarin's Vimizim For Morquio A Syndrome Approved By Health Canada
Lupin To Build 2 New U.S. R&D Centers
Japan Approves Roche's Alectinib In ALK+ NSCLC
View more headlines

 

Upcoming Training

 


Process Validation Guide: Regulatory Expectations And Best Practices
Date: Wednesday, July 16, 2014 • Time: 1:00 pm to 2:30 pm EST

Monitoring Informed Consent (IC): Frequently Asked Questions
Date: Thursday, July 24, 2014 • Time: 1:00 pm to 2:30 pm EST

Remote Monitoring Of Clinical Source Data: Why Not?
Date: Monday, July 28, 2014 • Time: 1:00 pm to 2:30 pm EST

Featured Downloads

Advanced Powder Transfer For Media And Buffer Preparation And Solids Additions
ILC Dover has developed a new powder transfer process to solve issues related to contamination and reduce the fill time of each powder bag.

Multisizer 4 Beckman COULTER CELL COUNTER Brochure
The Multisizer 4 COULTER COUNTER provides particle size distributions in number, volume, and surface area in one measurement, with an overall sizing range of 0.4 μm to 1600 μm. Discover the accuracy of the particle size analysis and particle counting abilities of the Multisizer 4.

Emphaze AEX Hybrid Purifier
The Emphaze Hybrid Purifier is a new, single-use clarifying device containing a multimechanism, all-synthetic, Q-functional anion exchange media integrated with a fine particle, bioburden-reduction membrane. The anion exchange media is composed of a quaternary amine hydrogel supported by a fine-fiber, nonwoven scaffold.

Streamlining The Regulatory Submission Process: EMC Documentum
Streamlining the regulatory submission process is essential to getting products to market faster today. But you need to create, review, and maintain essential submission-related documentation appropriately, even as regulatory rules and requirements vary and evolve by country and region. And if you’ve outsourced to contract research organizations (CROs), your submission process must enable reliable, seamless collaboration with these resources.
Browse the download library

Featured Multimedia

A Single-Use Method Of Removing Samples From A Closed System
Three 60 by ASI is a completely sanitary, single-use method of removing a sample from a closed system. There are no parts that must be disassembled, cleaned, and reassembled. The entire set (four vessels) can be applied to your fluid holding vessel or transfer line, used, and then discarded.

Featured Products And Services

Cryogenic Microtubes
Cryogenic Microtubes

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WHEATON

Sartobind Ion Exchange Membrane Adsorber Capsules
Sartobind Ion Exchange Membrane Adsorber Capsules

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Sartorius Stedim Biotech

Medical And Pharmaceutical Cold Chain Cargo Solutions
Medical And Pharmaceutical Cold Chain Cargo Solutions

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Southwest Airlines Cargo

Automated Tangential Flow Filtration System: SciFlex TFF
Automated Tangential Flow Filtration System: SciFlex TFF

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Parker domnick hunter Process Filtration

Dissolved Oxygen Optical Sensors
Dissolved Oxygen Optical Sensors

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Hamilton Company

Active Cold Chain Services
Active Cold Chain Services

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Envirotainer

LabAssay ALP Kit
LabAssay ALP Kit

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Wako Laboratory Chemicals

Macro-Prep t-Butyl HIC Media
Macro-Prep t-Butyl HIC Media

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Bio-Rad Laboratories, Inc.