Newsletter | March 10, 2014

03.10.14 -- Mission TransCelerate: Transforming The Drug Development Terrain

 
Bioresearch Online Newsletter
Departments:
Downstream Upstream Supply Chain Integrity Quality/Regulatory
» Featured Magazine Article
Mission TransCelerate: Transforming The Drug Development Terrain
By Rob Wright
During the ill-fated 1970 Apollo 13 mission to the moon, it was astronaut Jack Swigert who alerted ground control that something had gone terribly wrong when he uttered the phrase, "Houston, we've had a problem here." Those same words seem very fitting to the current state of affairs regarding the skyrocketing costs of drug discovery. Recent estimates place the expense of successfully bringing just one drug to market at between $350 million and $1.2 billion. However, in the past decade, companies having brought four to 13 drugs to market have watched the price tag reach stratospheric heights — orbiting $5 billion+. "I think the pain point has reached a threshold that's no longer bearable," states Dalvir Gill, Ph.D., CEO of TransCelerate BioPharma.
Featured Focus: Downstream
A Design Of Experiment (DOE) Approach For Purification Of Recombinant Proteins
By Xuemei M. He, Sherif Hanala, and Mark Snyder, Bio-Rad Laboratories, Inc.
Mixed-mode chromatography has become an important purification tool for downstream process developers. Under specific purification conditions one or more such interaction modes may be involved in the binding or repulsion between the target protein and the chromatography media. Therefore, the behavior of a protein during purification by mixed-mode chromatography is often not predictable on the basis of its pI or amino acid sequence.
ARTICLE: Trends And Challenges In Bioresearch: Managing Data And Navigating An Uncertain Regulatory Environment For Biotherapeutics, Part III
As the pharmaceutical industry pipeline continues to shift from traditional small molecule-based drugs to a new class of biologic therapeutics, bioresearchers need powerful bioanalytical techniques for the in-depth characterization of the protein of interest required at each development stage.
WHITE PAPER: A Closer Look At Validation In The Biopharma Process
By Ryan Mauro, Validations Sales Specialist, Sartorius Stedim Biotech
Process validation is the collection and evaluation of data throughout the manufacturing process, which establishes, scientifically, that there is consistency of quality, reproducibility, and traceability from batch to batch.
CASE STUDY: Rapid Chemically Defined Feed Media Development To Improve Simulated Cell Culture Processes
PODCAST: ASI Discusses Single-Use And Pressure Decay Testing
PRODUCT: Serum: Adult Bovine Sera
PRODUCT: Containment: Bag In Bag Out
» Upstream
APPLICATION NOTE: Crucial Factors In Choosing Bioreactors
By Kathrin Schmale, Strategic Marketing Manager, DASGIP; and Karl Rix, CEO, DASGIP BioTools, LLC
Advanced benchtop bioreactors can harmonize unit operations between development and production while supporting the aims of quality by design.
APPLICATION NOTE: Perfusion/Cell Retention: Attaching An ATF System To Different Bioreactors
GUEST COLUMN: Do Chinese Hamster Ovarian (CHO) Cells Specimens Require An Import/Export License?
By Reynaldo Roman for Marken
On December 21, 2012, the U.S. Fish and Wildlife Service (FWS) finally addressed an issue that has been of significant debate among importers of Chinese hamster ovary (CHO) cell specimens and trade experts. FWS informed the trade community that only shipments of actual CHO "cell," "cell cultures," and "cell lines" are regulated by the agency and require an import/export license for trade.
VIDEO: Accurate Testing Of Protein In Tumor Cells: NanoDrop 3300
DATASHEET: Anti Iba1, Polyclonal Antibody, Rabbit
By Wako Laboratory Chemicals
WEBINAR: Using Microbioreactors To Mimic Perfusion Cultures
By Irvine Scientific
SERVICE: Product Characterization Services
PRODUCT: 2D Bar Code Reader For Storage Vials
» Supply Chain Integrity
ARTICLE: Setting New Standards In ULD Handling
By Staffan Ingfors, Head of Global Service Network, Envirotainer 
With more than 50 unit load device (ULD) handling locations worldwide, Envirotainer operates the world's largest independent network of ULD ground handling and repair services.
CASE STUDY: How DSC Helped Kimberly-Clark Healthcare Drive Down Costs While Improving Service
BROCHURE: Audit/Assessment And Engineering Solution Services
PRODUCT: Thermal Pallet Shipper: CSafe RKN
PRODUCT: Next Flight Out: Expedient Shipping Solution
» Quality/Regulatory
ARTICLE: Understanding Test And Measurement Equipment Performance In The Laboratory
By Michael Boetzkes, Quality Manager, Vaisala Canada Inc. Life Science Division
Any good quality manager knows that assumptions about an instrument can lead to unpleasant surprises during the calibration cycle. Test and measurement equipment play a critical role in most production and development processes. These instruments are used to make decisions regarding the effectiveness of processes and to ensure product quality.
ARTICLE: How To Develop A Successful Regulatory Strategy
ARTICLE: The Benefits Of Terminal Sterilization Of APIs And Pharmaceutical Fillers
CASE STUDY: Remote Monitoring Solution Improves Compliance
BROCHURE: Multisizer 4 Beckman Coulter Cell Counter
BROCHURE: High Air Flow (HAF) Air Filters
PRODUCT: Containment: Granulator Technology
» Most Recent News
FDA Overhauls Non-Prescription Drug Approval Process
HIV Prevention Treatment Has Major Potential
Study Claims Patent Trolls Could Affect Drug Companies
ProBioGen And Merus Enter License Agreement For GlymaxX Technology
FDA Gives Bristol-Myers' Daclatasvir And Asunaprevir Breakthrough Designation For Hepatitis C
UPCOMING EVENT
Registration for the 2014 AAPS National Biotechnology Conference is NOW OPEN! For more information and to register please visit www.aaps.org/NBCRegister.

Find everything you could want in pharmaceutical biotechnology programming in San Diego. Attendees can attend one conference organized into four conference workstreams:
  • Biomanufacturing
  • Biomarker and PK/PD
  • Research and Discovery
  • Immunogenicity and Administration Routes
The scientific programming at the 2014 National Biotechnology Conference will feature symposia, roundtables, sunrise sessions, short courses, and workshops.
UPCOMING TRAINING

HIPAA And Source Data Access: Dispelling The Myths
Date: Friday, March 14, 2014 • Time: 1pm – 2:30pm EST

Vendor Qualification And Compliance: What Sponsors And CMOs Must Know
Date: Tuesday, March 25, 2014 • Time: 1pm – 2:30pm EST

Computer Systems Validation (CSV) — Avoiding The Top Five Regulatory Pitfalls
Date: Wednesday, April 9, 2014 • Time: 1pm – 2:30pm EST
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