Newsletter | October 3, 2012

10.03.12 -- 3 Risks In Platform Processes - And How To Mitigate Them

Bioresearch Online Newsletter

In This Issue:

Featured Articles

3 Risks In Platform Processes - And How To Mitigate Them
By SAFC
A platform process is a set of standardized protocols and reagents that can be used to support a variety of clinical molecules. An enhancement to the platform can be spread across multiple clinical molecules, improving an organization's return on investment.


A Model For Improved Cost Of Goods In Cell Process Therapy
By Matthieu Egloff, ATMI and Guillaume DeViron, Norived
This white paper presents a cost model using bottom-up simulation. The article includes supporting evidence from studies of migrating translation research into clinical-scale manufacturing.

Spotlight On Risk Mitigation

Raw Materials Risk Mitigation And Management
Protecting your raw materials is a vital part of your process – and one that should be taken seriously. Repercussions like plant shut-downs and drug shortages — stemming from events like virus contamination — can be far-reaching and difficult to overcome.


Flexible Containment Solutions Guide: Coaxial Neck DoverPac®
Given the increase in highly potent API manufacturing, the use of the coaxial neck DoverPac system, with either rigid isolators or flexible enclosures, is a complementary processing option.


Implementing A Supply Chain Risk Management Process
To paraphrase a television news show catch line, "It's 10 p.m. Do you know where your product is?" Every life sciences executive has asked this question in one form or another. And, most of us have wondered about the answer. This becomes a much harder question to honestly answer as we grow our supply and fulfillment organizations in multiple countries in our quest to control costs and compete.


Pharma And Biopharm, Suppliers Can Cost You More Than You Think
There are many causes of downtime in pharmaceutical and biopharmaceutical production, and your suppliers can be a major cause of it, but fortunately you can mitigate risks.

Industry News

Possible Cure For Dementia?
Major Cancer Protein Amplifies Global Gene Expression
PDUFA V Sets New Course For Regulatory Science: Joint BIO/PhRMA Statement
Molecular Insight Initiates Phase II Trial For Prostate Cancer Molecular Imaging Drug
GeoVax Awarded $1.9 Million U.S. Government Grant For HIV/AIDS Vaccine Program
Genentech's Trastuzumab Emtansine Significantly Extended Survival In People With Aggressive Form Of Breast Cancer
FDA Approves Bayer's Stivarga Tablets As Treatment Of Metastatic Colorectal Cancer
Avid Bioservices Awarded HIV Vaccine Development/Manufacturing Contract
FDA Says ViroPharma, Halozyme Can Continue Clinical Development Of Subcutaneous Cinryze® With Recombinant Human Hyaluronidase
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Agilent Technologies

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ViralSEQ Mouse Minute Virus (MMV) Detection Assay
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Life Technologies

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