Newsletter | August 18, 2014

08.18.14 -- Pfizer Partners With 23andMe in IBD Research; Preparing For the Biopharmaceutical Revolution

Bioresearch Online Newsletter
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Featured Focus

How To Prepare A Facility For The Biopharmaceutical Revolution
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
Drug discovery is an inherently inefficient process. It takes thousands of failed compounds before one can get approved as safe and efficacious, and this effort does not come at a low cost. Because of this, the industry is constantly looking for ways to bring safe, compliant, and profitable drugs to market faster and cheaper. The Patheon facility in Brisbane, Australia, exemplifies the facility needed to survive the future of pharma. But how did they do it?

Featured Content

Guest Column: Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers
By Dr. Kirk Beebe, Director of Application Science, Metabolon, Inc.
Biologics are an integral part of the landscape of current therapies as pipelines continue to fill with them. Due to their importance, and this ever-expanding pipeline, the demands continue to escalate due to cost pressure, competition, regulatory requirements, disposable systems, and biosimilars. To date, these demands arguably have primarily been met with empirical understanding. However, there is a critical need for new approaches, tools, and technologies to deliver deeper understanding beyond the empirical realm.


Posters: Validation Of A Novel Tumoroid-Based Cell Culture Model To Perform 3D In Vitro Cell Signaling Analyses
By BioTek Instruments, Inc.
This poster demonstrates the ability to capture HTRF whole well and fluorescence imaging data using the Cytation 3 from HCT116 cells cultured in 3D using the RAFT system to generate relevant, in vivo-like cell signaling and cytotoxicity results from lead compounds.


Guest Column: The Importance Of Scaling Single-Use Equipment
By Maik W. Jornitz, President, G-CON Manufacturing LLC
Process equipment choices, whether multiuse or single-use, are commonly made early in medicinal drug development activities and in test labs. Choices made in the test lab about which equipment would be tested are often dependent on either the availability of the equipment or knowledge about it. This often results in a legacy equipment choice. However, since the volumes used within the early drug development stages are very small, the process equipment used might not represent the process scale design or, even worse, is not scalable to process volumes. A proper plan and scalability investigation should precede the choice and testing of equipment, especially when being single-use.


Application Note: Compound Profiling And Toxicity
By Metabolon
Utilizing a systems approach to drug discovery has generated a multitude of high affinity compounds for various classes of molecular targets with different degrees of disease state validation.

Industry News

Pfizer Partners With 23andMe In IBD Research
Mirati's Mocetinostat For Lymphoma Designated As Orphan Drug
CureDuchenne Expands Collaboration With Prosensa
3SBio Licenses Anti-Leukemic Leukotuximab From DiNona
Daily Aspirin Can Lower Deaths Due to Bowel and Stomach Cancers
View more headlines

Upcoming Event

IBC Life Sciences' BioProcess International Conference & Exhibition, the industry's #1 BioProcessing event, is taking place October 20 to 23, 2014, at the Hynes Convention Center in Boston, MA. Find new ideas and make new contacts to help you meet the demands of diverse product portfolios in an evolving biomanufacturing landscape. Download a copy of the brochure today to see what this year’s event has to offer. http://bit.ly/1kwZCAK

 

Upcoming Training

 


Lyophilization: An Introduction To The Scientific Principles
Date: Wednesday, August 20, 2014 • Time: 1:00 pm to 2:30 pm EST

Computer Systems Validation (CSV): Avoiding The Top Five Regulatory Pitfalls
Date: Thursday, August 21, 2014 • Time: 1:00 pm to 2:30 pm EST

Featured Downloads

Paperless Environmental Monitoring For Aseptic Pharmaceutical Manufacturing
Aseptically produced, parenterally administered biopharmaceutical products must be free of unwanted bacterial or viral contaminants.

RAP e2 Container: Temp-Controlled Containers For Extreme Requirements
Envirotainer presents its latest addition to its portfolio of active temperature-controlled air cargo containers. Designed for the most extreme requirements of the healthcare industry, the RAP e2 container maintains product temperatures in the +2°C to +8°C range, controlled room temperature (+15°C to +25°C) range, or at any chosen set temperature between ±0°C and +25°C in nearly any ambient condition appearing along shipping routes globally. The RAP e2 is a certified air cargo ULD (unit load device) ensuring seamless handling throughout the supply chain worldwide. The unit can be carried on board the most common wide-body aircraft types.

How To Avoid FDA 483s For Temperature, Humidity, And Other Controlled Environments
The following article shows three excerpts from some of the more common “observations” noted in Form 483 letters. (The names have been left out in this application note, but are a matter of public record). Each of these deviations involved environmental conditions (temperature, humidity, etc.) in a variety of GxP settings; they range from failure to properly validate containers for human cell and tissue products to a lack of temperature records in an aseptic processing area of a drug manufacturing facility.

Parenteral Development And Manufacturing
Large molecule or small, Patheon brings together exactly the right technologies, services, and experience for you to develop and manufacture a successful parenteral product.
Browse the download library

Featured Multimedia

Connected Sensors Unlock New Value In Transportation And Logistics
New applications for the tracking of cargo and assets that are time and temperature-sensitive and of significant value.

Bulletin Board

An Exciting Change On The Horizon
To assist our audience with getting the specific scientific and business information they need to do their job better, we are narrowing our editorial coverage of this site to the bio manufacturing industry. As a result, this September, Bioresearch Online will become BioProcess Online.

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Envoy Diagnostic Insulated Shipper
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Sonoco ThermoSafe

Plastic Liter Tank
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ASI Life Sciences

Therapeutic Supply Chain
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New Brunswick S41i CO2 Incubator Shaker
New Brunswick S41i CO2 Incubator Shaker

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Eppendorf, Inc

E-4031 For Cell Membrane Study
E-4031 For Cell Membrane Study

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Wako Laboratory Chemicals

PRP-C18 Reversed-Phase HPLC Columns
PRP-C18 Reversed-Phase HPLC Columns

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Hamilton Company

DrumQuik PRO Series: Drum Connectors
DrumQuik PRO Series: Drum Connectors

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Colder Products Company

Hydrophobic Interaction Chromatography Media
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Bio-Rad Laboratories, Inc.