Newsletter | April 7, 2014

04.07.14 -- Antibiotic R&D Gains Traction; EMA Validates HCV Genotype 1 Treatment

Bioresearch Online Newsletter
Upstream Downstream Supply Chain Integrity Quality/Regulatory
» Featured Magazine Article
Antibiotic R&D Gains Traction: A Mid-Cap Company Leads The Way
By Cathy Yarbrough, Contributing Editor
The industry leader in developing antibiotics against “superbugs” and other multidrug-resistant bacteria is not a Big Pharma corporation, but Cubist Pharmaceuticals, headquartered in Lexington, MA.
Featured Focus: Upstream
Maximize Cell Growth And Isobutanol Production With Real-Time MS Data
By James Glenn and Claudia M. Huether
This application note describes the integration of a Thermo Scientific® Prima® dB Mass Spectrometer (MS) with DASGIP Parallel Bioreactor Control Systems implemented at Gevo®, Inc. in Englewood, CO. The availability of real-time MS data will aid in maximizing cell growth and isobutanol production.
APPLICATION NOTE: The Effect Of Cell Culture Method On Long-Term Primary Hepatocyte Cell Health
APPLICATION NOTE: Increase Enzyme Stability In Chiral Production With Purification And Immobilization
ARTICLE: Raw Materials Risk Mitigation And Management
By Marlin Frechette, Director, Regulatory Affairs and Quality Systems, Irvine Scientific
Protecting your raw materials is a vital part of your process — and one that should be taken seriously. Repercussions such as plant shut-downs and drug shortages — stemming from events such as virus contamination — can be far-reaching and difficult to overcome. To help safeguard your product, and to avoid potential adverse events, you can keep the following things in mind when sourcing media.
DATASHEET: Real-Time Monitoring Of Key Bioprocess Parameters: Nova BioProfile Analyzer Integration
By DASGIP Information and Process Technology GmbH an Eppendorf company
PRODUCT: Syringes And Needles: Precise Fluid-Measuring Devices
» Downstream
ARTICLE: Ensure Integrity And Prevent Contamination In Single-Use Bags
By Trisha Gladd, Editor, Bioresearch Online
As single-use systems continue to gain in popularity, so does the use of single-use bags. A single contract manufacturer can use thousands of bags per year. Gallus Biopharmaceuticals has used more than 40,000 bags in just the past decade. Due to the volume increases in some of these bags, the prevention of possible contamination issues has never been more important. More pharma manufacturers are now looking to perform point-of-use tests to ensure the integrity of the bags they are using.
APPLICATION NOTE: Optimization Of Monoclonal Antibody Production Employing Noninvasive Sensor Technology
APPLICATION NOTE: Removal Of Host Cell Proteins During Monoclonal Antibody Purification
APPLICATION NOTE: Rapid And Efficient Determination Of Kinetic Rate Constants
POSTER: Progress On A Fully Disposable Downstream Platform
PRODUCT: Optimize Filtration Processing, Maximize Filter Life
PRODUCT: Integrated Genderless Single-Use Sterile And SIP Connector
» Supply Chain Integrity
CASE STUDY: Ensuring The Safe Transportation Of Critical Milk For Twin Infants
By Linda Kim, General Manager, Marken Korea
As a professional working in the pharmaceutical research and development industry, Mrs. Tan was also a mother of twins. She found herself in search of a safe and secure means to transport expressed breast milk across Asian borders to her infants back home.
VIDEO: Connected Sensors Unlock New Value In Transportation And Logistics
Featuring Carrie Magillivray, Program VP Mobile Services, M2M and Network Infastructure
New applications for tracking of cargo and assets that are time- and temperature-sensitive and of significant value.
WHITE PAPER: Medical Device Companies Turning To New Breed Of Supply Chain Partner
SERVICE: Logistics Audit/Assessment And Engineering Solution Services
» Quality/Regulatory
ARTICLE: The Changing Regulatory Landscape: How Drug Sponsors And CMOs Can Navigate It Together
By Milton Boyer, President, OSO Biopharmaceutical Manufacturing
The changing regulatory environment is shaping a new paradigm between drug sponsors and contract manufacturing organizations (CMOs). One key aspect is demonstrated quite nicely in a case study from February 2012 (read it here), when the FDA issued a warning letter to a contract manufacturing organization. The warning letter stated in part:


“In your response, you state that you have informed your clients on the importance of validating the methods, but they have chosen not to validate the methods. In addition, you state that you will inform them again in writing. Your response, however, is inadequate because you do not provide your firm's planned corrective actions for this cGMP violation. You are responsible for ensuring that the test methods used by your firm are validated.” (Emphasis added)

WHITE PAPER: A 15-Minute Guide To Compliant Document Management For Life Sciences
CASE STUDY: Decontamination Of Laboratory Animal Research Rooms Using Vaporized Hydrogen Peroxide (VHP)
CASE STUDY: Evolving A Global Document And Knowledge Management Solution At Arizona Chemical
SERVICE: Cytotoxic Handling Services
PRODUCT: Pegasus SV4 Virus Removal Filters
PRODUCT: Blending Containment
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Source Data Review (SDR) vs. Source Data Verification (SDV) — A Site Monitoring Best Practices Update
Date: Friday, April 11, 2014 • Time: 1pm – 2:30pm EST

Root Cause Analysis for GCP — A Risk Action Plan Guide
Date: Tuesday, April 15, 2014 • Time: 1pm – 2:30pm EST
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