Newsletter | June 18, 2014

06.18.14 -- Immunomedics Receives FDA Orphan Drug Status For ADC To Treat Pancreatic Cancer

Bioresearch Online Newsletter

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Outsourced Pharma West Conference And Exhibition

Outsourced Pharma West Conference And Exhibition

November 10 and 11, 2014
Hyatt Regency, San Francisco, CA

Who should attend? Pharmaceutical and biopharm executives who form and manage outsourcing partnerships.
What's on the agenda? Industry leaders providing educational sessions focused on best practices and lessons learned to help you avoid costly mistakes others have made in their outsourcing experiences.

Brought to you by Life Science Leader magazine, BayBio, and Outsourced Pharma.

Space is limited. Register today!

Featured Focus

How Genzyme Got Its Manufacturing Mojo Back
By Nick Taylor, Contributing Editor
In the summer of 2009, Sandra Poole, newly appointed head of Genzyme’s Allston Landing biologics plant, and the site’s leadership team were confronting arguably the toughest job in biotech at the time. Days before her arrival, Genzyme shut down the site after discovering a viral contaminant. There would be no settling-in period. The entire company and thousands of patients were relying on this team to fix the problem.

Featured Content

White Paper: Facing The Challenges — Single-Use Approaches To Powder Transfer
By Chris Rombach, ILC Dover
Media and buffer preparation is a key part of the biopharmaceutical manufacturing process, and while it doesn’t have to be carried out in sterile conditions, improving the powder transfer process makes this step cleaner, safer, and more efficient, protects personnel, and could cut time and costs as well.


White Paper: Connection Technology Advances Closed-System Processing
By John Boehm, Business Unit Manager, Colder Products Company
The global demand for new biologics and vaccines, combined with the growing emergence of biosimilars, is challenging drugmakers to re-evaluate their processes and seek ways to make them more flexible, reliable, and cost-effective.


Article: 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.


Application Note: Options For Shortening Integrity Test Time Of Sterile Filters
By Sartorius Stedim Biotech
The integrity testing of sterile filters constitutes a critical and mandatory regulatory step in biopharmaceutical production processes.

Most Recent News

Immunomedics Receives FDA Orphan Drug Status For IMMU-132 In Pancreatic Cancer
ViiV Healthcare And Janssen Collaborate On HIV Drug Combo
Tonix Receives FDA Clearance For PTSD Drug IND
Merck Serono And MorphoSys Enter Into Immuno-Oncology Partnership
Cellectis and CELLforCURE Sign Into Manufacturing Agreement
View more headlines

 

Upcoming Training

 


The Future Of Biosimilars: Addressing Regulatory Challenges
Date: Thursday, June 19, 2014 • Time: 1 pm to 2:30 pm EST

Featured Downloads

Reveleris Flash Cartridges
Get the most out of your flash applications by choosing Reveleris flash cartridges, the only flash cartridges designed by a silica expert for ideal chromatographic performance.

HyQ Labtainer BioProcess Containers
Thermo Scientific HyQ Labtainer BioProcess Container Systems are small-volume liquid handling systems for cell culture and bioprocessing.

Flexsafe Single-Use Bags
Standard Flexsafe 2D validation bags made of the new polyethylene S80 film are designed for small-scale investigations and for the validation of the Flexsafe bag family. They are available in 150 mL and 500 mL volumes to support end users' process development and validation testing.

An Affordable Way To Ship Temperature-Sensitive Cargo
The demand for transporting medical and pharmaceutical products is exploding. So too are the challenges associated with moving time- and temperature-sensitive cargo in a manner that keeps the cold chain intact, and ensures documented quality of delivery.
Browse the download library

Featured Multimedia

Why We Put An 8-Year-Old Girl On A Container
Could an 8-year-old girl make a better cold chain? Could she make people care more about what they do?

Bulletin Board

Transform And Redefine Biopharmaceutical Purification With Innovative Process Solutions
In this webinar you will learn about the Emphaze AEX Hybrid Purifier — a multi-mechanism clarification device that embodies the philosophy of innovation necessary to transform and redefine the mAb purification process.

Featured Products And Services

Mobile Refrigeration/Freezer Unit: Acutemp AX27L
Mobile Refrigeration/Freezer Unit: Acutemp AX27L

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CSafe Global

The Client Experience: Key To CDMO's Success
The Client Experience: Key To CDMO's Success

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Therapure Biopharma Inc.

QCanywhere Cloud-Based Quality Control
QCanywhere Cloud-Based Quality Control

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Global Vision Inc.

CELLine Bioreactors Advanced Cell Cultivation Devices
CELLine Bioreactors Advanced Cell Cultivation Devices

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WHEATON

Optimize Filtration Processing, Maximize Filter Life: SciFlex NFF
Optimize Filtration Processing, Maximize Filter Life: SciFlex NFF

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Parker domnick hunter Process Filtration

API (Finished And Intermediate) Shipment Services
API (Finished And Intermediate) Shipment Services

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Marken

Easy-To-Use Preparative System, For Laboratory-Scale Protein Purification
Easy-To-Use Preparative System, For Laboratory-Scale Protein Purification

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GE Healthcare Life Sciences

Clinical Trial Cold Chain Logistics
Clinical Trial Cold Chain Logistics

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World Courier Management