Newsletter | October 31, 2012

10.31.12 -- 3 Problems To Avoid When Establishing A Quality System

In This Issue:
3 Problems To Avoid When Establishing A Quality System Raising Life Sciences Capital: An Alternative Way	Laser Spotlight Reveals Machine 'Climbing' DNA ViaCyte Receives $10.1M Strategic Partnership Award From CIRM To Continue Development Of Diabetes Therapy

Featured Articles
3 Problems To Avoid When Establishing A Quality System By Rosario Quintero-Vives, Senior Regulatory and Compliance Specialist, RQV Consulting For some products on the market, quality is a luxury or an option. However, when your product is under the FDA umbrella, quality is required by law if you want to do business in the United States. In the pharmaceutical industry, the customers we serve have very precise expectations when it comes to product quality — nothing but the best, with the highest standards of production and manufacturing.

Raising Life Sciences Capital: An Alternative Way By Todd Wyche, Brinson Patrick There are various strategies public life sciences companies use to raise equity capital. Common approaches are conventional financing vehicles such as marketed follow-on offerings, registered directs, and private investments in public equities (PIPEs). These methods require selling shares in large quantities at a fixed price at one specific time.

IFPAC®-2013: The Premier International Event On QbD And PAT

January 22 to 25, 2013 • Baltimore Marriott Waterfront

IFPAC is the essential meeting place for the latest developments in Process Analytical Technology (PAT) and Quality by Design (QbD). IFPAC provides a dynamic platform for proactive discussions between industry, government, research institutions, and manufacturers/suppliers in the biotechnology/pharmaceutical and related industries. IFPAC-2013 will provide an opportunity to interact with industries that have been using PAT for nearly 60 years! Email: info@ifpacnet.org; Phone: (847) 543-6800; Web: www.ifpacpat.org

Featured Downloads
Separation Of Serine Proteases By Para-Aminobenzamidine Affinity Chromatography A diverse variety of chromatographic media can be employed for commercial manufacture of therapeutic biologicals, all of which interact in one way or another with the unique set of characteristics inherent to a protein of interest.

PUR-Sense™ Model 3800 Steam Sterilizable pH Sensor: Product Brochure Designed for accuracy and stability in heat-intensive applications, the new PUR-Sense 3800 series pH sensors are optimized for autoclaving and steam sterilization. Building on PERpH-X® and AccuGlass® technology, the 3800 sensors exhibit unparalleled stability after exposure to high-temperature sterilization.

Streamlining Compliance And Quality Management Across The Enterprise This white paper explains the inherent benefits associated with implementation of an enterprise-wide compliance and quality management system for life sciences companies. It also provides a brief summary of Pilgrim Software's best practices and value propositions within the enterprise compliance and quality management space.

Taking Pharmaceuticals Off The Beaten Path: Fisher BioServices Finds The Solution For Logistics Nightmares With literally millions of R&D dollars on the line, transporting temperature-sensitive materials for pharmaceutical clinical trials demands the absolute best in thermally controlled packaging.
Browse the download library

Industry News
	Thrasos Secures $35M To Fund THR-184 Phase 2 Clinical Program For Treatment Of Acute Kidney Injury
	Laser Spotlight Reveals Machine 'Climbing' DNA
	ViaCyte Receives $10.1M Strategic Partnership Award From CIRM To Continue Development Of Diabetes Therapy
	Transparency Life Sciences Launches Indication Finder™ Crowdsourcing Tool For Drug Repurposing
	Valent BioSciences Hires Mike Daily To Manage New Production Facility
	Mediomics LLC Receives Phase II SBIR Contract: Awarded $997,251 To Develop New In-Process Analyzer For Biologics
	Mirna Therapeutics Secures $34.5M Series C Financing To Advance Oncology microRNA Pipeline Into The Clinic
	China Biologic Receives GMP Certificate For Human Coagulation Factor VIII To Start Commercial Manufacturing This Month
	Amarantus BioSciences Announces MANF Demonstrates Superiority Over GDNF In Neurorestoration Behavioural Animal Model Of Parkinson's Disease
View more headlines

Upcoming Event

IBC's Drug Product Quality Summit will focus on final-stage drug product development for fill/finish, including all the hot-button issues that have resulted in millions of dollars lost in the industry due to 483s, clinical holds, and lots rejected due to quality problems. Most of all, it will provide you insights on how to avoid these situations. Learn more.