Newsletter | February 12, 2014

02.12.14 -- How To Launch A Biotech Start-Up

Bioresearch Online Newsletter
Quality/Regulatory Downstream Upstream Supply Chain Integrity
» Featured Magazine Article
How To Launch A Biotech Start-Up
By Suzanne Elvidge, Contributing Editor
Whether in the early days of DNA cloning in the 1970s, or the boom of the 1980s and 1990s, biotechnology and biotech start-ups have represented the cutting edge of the biopharma and healthcare industry. For those fascinated by the idea of entering the hurly-burly start-up world, Index Ventures hosted "Playground" in October 2013, covering the entire process — from thinking up the idea for a new company to planning for the exit.
Featured Focus: Quality/Regulatory
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 because of 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.
WHITE PAPER: A 15-Minute Guide To Compliant Document Management For Life Sciences
APPLICATION NOTE: A Comparison Of Performance Using Three Bioreactor Systems
BROCHURE: Docu-Proof Text Inspection 
PRODUCT: Remote Sensor Node For Mesh Networking Communication
PRODUCT: Contract Sterilization Services For Microbial Control
PRODUCT: Centrifugal Vacuum Concentrators: miVac
» Downstream
WHITE PAPER: Understanding Bioprocess Variation Ensures Facility Fit During Technology Transfer
By Nick Hutchinson, Market Development Manager, Parker domnick hunter Process Filtration
The scale-up and transfer of manufacturing processes is common during the lifecycle of biopharmaceutical molecules. 
ARTICLE: Overcome Preculture Process Challenges With Single-Use Systems
APPLICATION NOTE: Downstream Protein Purification: Integrate Sterile And Efficient Temperature Control
CATALOG: Chromatography Consumables Every Lab Needs
BROCHURE: HyQ Harvestainer BioProcess Container 
PRODUCT: Bio-Beads SM-2 Adsorbents
PRODUCT: Integrated BioBanking System: Enhancing Storage And Tracking
» Upstream
APPLICATION NOTE: Cultivation Of Human CAP Cells: Evaluation Of Scale-Down Capabilities
By Claudia M. Hüther-Franken, Helmut Kewes, and Dr. Michael Schomberg, DASGIP Information and Process Technology GmbH an Eppendorf company
CEVEC has established a master cell bank (MCB) of CAP cells growing in suspension, tested and certified according to ICH guidelines and European Pharmacopeia. Simple and reliable protocols allow for the fast generation of customized producer cell lines for pharmaceutically relevant proteins based on the parental permanent CAP cells under controlled and optimized conditions.
APPLICATION NOTE: Parallel Integrity Testing Of Small Venting Filters
APPLICATION NOTE: Significantly Improve FoxP3 Staining In Human Whole Blood
PRESENTATION: BIOSIMILARS: Global Terminology, Strategy, And Pathways
BROCHURE: Product Characterization Services 
POSTER: Measuring The Performance Of Microplate Dispensers As Part Of A Method Scale-Up Process
PRODUCT: FTMS Mass Spectrometer System
» Supply Chain Integrity
ARTICLE: Marine Transportation Becomes Feasible For Pharmaceuticals
WHITE PAPER: Clinical Trial Logistics In Africa: Ensuring Quality, Compliance, And Control
CASE STUDY: When Failure Is Not An Option In The Supply Chain
DATASHEET: Mobile Refrigerator/Freezer: AcuTemp 
PRODUCT: Marken Solo Clinical Trials Management System
» Most Recent News
Johnson & Johnson's Agreement With Yale Expected To Benefit Industry
Can JAK Inhibitors Treat Stomach And Colorectal Cancers?
DRYPOUR™ Packaging System To Minimize Caking Of Pharmaceutical Raw Materials Introduced
The FDA Has Approved Hetlioz For Sleep-Wake Disorder
Clinical Trials For Two Alzheimer's Drugs Are Disappointing
Upcoming Event
INTERPHEX is the single source for complete biopharmaceutical and pharmaceutical manufacturing solutions to confidently process all dosage forms of life-enhancing drugs. See, touch, and procure the latest technologies and innovations, March 18 to 20, 2014, at the Javits Center in New York City. For more information visit

Quality By Design (QbD) In Clinical Trials: Build Bullet-Proof Protocols
Date: Tuesday, February 18, 2014 • Time: 1pm – 2:30pm EST

Monitoring Electronic Health Records (EHRs): Frequently Asked Questions
Date: Thursday, February 27, 2014 • Time: 1pm – 2:30pm EST

Writing Clinical Monitoring Reports: Using the Liquid Report Writing Method
Date: Friday, February 28, 2014 • Time: 1pm – 2:30pm EST
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