This week’s biotechnology news headlines include, new Alzheimer’s disease model, two new treatments approved for pulmonary fibrosis, AbbVie recommnends rejection of Shire’s offer, FDA’s guidance on biologics exclusivity, Gilead’s Hepatitis C drug wins approval, and Ebola treatment developments.

Cell Culture Events

2-Day Workshops on Modeling and Simulation in Biomanufacturing Operations

Bio-G is hosting 2-Day workshops around the country on Modeling and Simulation in Biomanufacturing Operations. Attendees work in hands-on sessions with the Bio-G Real-Time Modeling System (RTMS) to solve challenging manufacturing problems, including:

• Modeling and Optimization
• Production Planning and Scheduling
• Cycle Time Reduction and Debottlenecking
• Capacity Analysis
• Analysis of Utilities and Waste Streams

For more information on the 2-Day Workshops, including cities and dates, go to http://www.bio-g.com/post/2-day-workshops.

October

BioProcess International Conference & Exhibition

Conference: October 20-23, 2014, Exhibition: October 21-23, 2014

Hynes Convention Center, Boston, MA

http://bit.ly/1u0LZkY

Complete programming coverage of the full bioprocessing continuum – featuring 65 innovative case studies and 70 new data presentations intended for companies of all sizes and at every stage of development.

The world’s largest bioprocess exhibition – featuring over 150 exhibitors, lounges, and the BPI Theater with live product launches to help you plan future purchasing decisions.

Face-to-Face Networking opportunities that no other bioprocessing event can offer, plus access BPI’s event specific partnering tool to schedule meetings.

Featured Talks at BPI:

Single-use systems – expanding platforms

Thursday, October 23, 9:20–9:45 a.m.

Daniel Nelson, Integrated Solutions Product Manager, Thermo Fisher Scientific

Daniel first began using single-use technology as a biochemical engineer. As a product manager, he has developed several new bioprocessing products and continues to explore solutions to unmet bioproduction challenges.

Learning objectives:

1. Explore recent single-use technology advancement
2. Assess technology performance
3. Evaluate technology during process implementation

CaptureSelect™ technology: introducing one-step selectivity in the purification of biological products

Thursday, October 23, 11:00–11:30 a.m.

Frank Detmers, Ph.D., Ligand Application Director, Bioproduction, Thermo Fisher Scientific

After a career in science, Dr. Frank Detmers joined the company in 2004. Since then he has been responsible for directing programs focused on the immobilization of affinity ligands on any solid support, resulting in a diverse range of products for the purification of biotherapeutics.

Learning objectives:

1. Better understanding of the use of single domain antibodies as affinity ligands in chromatography
2. Introduction to a new class of large scale resins for purification of antibodies and antibody formats offering unique selectivities.

November

Don’t miss Life Technologies’ 2nd Annual, 24 Hours of Stem Cells Virtual Event

Register free for the 2nd Annual 24 Hours of Stem Cells virtual event, a major Stem Cell Research event running concurrently around the world for 24 hours on November 06, 2014.

Join the event anytime between:
November 5, 6:00 PM through November 6, 8:00 PM, US Eastern Time (November 5, 11:00 PM, through November 7, 1 AM, Greenwich Mean Time)

Please see our summary of the event from last year, “Today an Innovative Virtual Stem Cell Conference is Taking Place.”

Well Characterized Biologicals – November 3-4, 2014 – Washington Marriott at Metro Center Washington, DC

http://www.ibclifesciences.com/WCB/overview.xml

European Antibody Congress 2014 – November 10-12, 2014 – Geneva, Switzerland

http://www.terrapinn.com/conference/european-antibody-congress/index.stm

World Orphan Drug Congress, Europe 2014 – November 12-14, 2014 – The Egg, Brussels, Belgium

A panel on regional approaches to orphan drug assessment at the World Orphan Drug Congress 2014 provides the opportunity to question NICE, RIZIV, G-BA, Haute Autorite de Sante, IPPOSI and AIFA on their markets. Join Europe’s largest commercial gathering for rare disease industry stakeholders at the Congress this November. Download the full brochure @ terrapinn.com/CellCultureDish

3^rd Annual Cell Culture and Bioprocessing Congress – November 17-18^th, 2014 – London, UK

This Congress is an executive platform for over 170 experts working in cell line development, cell line engineering, up and downstream operations, fermentation and biologics production. The Congress brings together leading experts to discuss ways to support this growth and overcome industry-wide challenges, and will be supported by key industry solution providers like Merck Millipore, Eppendorf, UPM, Solentim and Hamilton. Problems to be discussed include cell line stability, cell line authentication, scale-up improvements, contamination control and increasing reliability and consistency between batches. Please take a look at the website for more detail  http://www.cellculture-congress.com/

Headlines

“Breakthrough Replicates Human Brain Cells for Use in Alzheimer’s Research,” The New York Times

“For the first time, and to the astonishment of many of their colleagues, researchers created what they call Alzheimer’s in a Dish — a petri dish with human brain cells that develop the telltale structures of Alzheimer’s disease. In doing so, they resolved a longstanding problem of how to study Alzheimer’s and search for drugs to treat it; the best they had until now were mice that developed an imperfect form of the disease.”

If you like this story, please see our blog titled “Stem Cell Culture Advances – The Final Blog in the ISSCR Series”

“FDA approves two treatments from Roche, Boehringer for fatal lung disorder,” Reuters

“The U.S. health regulator approved two treatments for use in idiopathic pulmonary fibrosis (IPF), marking its first-ever approvals for the fatal lung disease that has no clear etiology and no cure.”

If you like this story, please see our blog titled “A High Throughput, Scalable Solution to Upstream Process Development”

“Molecule promises to speed up discovery of universal anti-Ebola drugs,” Medical News Today

“A synthetic molecule that imitates an important section of the Ebola virus promises to speed up discovery of anti-Ebola agents capable of dealing with all current strains and any that emerge in future epidemics.”

If you like this story, please see our blog titled “Highlights from IBC’s 4th Annual Cell Therapy Bioprocessing Conference”

“AbbVie Board Recommends Shareholders Reject Shire Acquisition,” The New York Times

“The biggest corporate takeover of the year has essentially been called off. In the wake of new rules penalizing inversions, AbbVie has walked away from its bid to acquire Shire, the Irish drug maker, for $54 billion.”

If you like this story, please see our blog titled “Raw Material Sourcing for Cell Culture Media – Important Considerations”

“Human testing begins on NewLink Genetics’ Ebola vaccine,” Reuters

“Human testing of an experimental Ebola vaccine developed by the Canadian health agency and licensed to NewLink Genetics Corp has begun, Canadian health minister Rona Ambrose said.”

If you like this story, please see our blog titled “Flexible Facilities for Biopharmaceutical Manufacturing”

“FDA’s Draft Guidance on Biologic Exclusivity Needs Revisions, Industry Groups Say,” Bloomberg BNA

“In recent comments to the Food and Drug Administration, industry groups said the agency’s draft guidance on determining exclusivity periods for biologic products needs revisions.”

If you like this story, please see our blog titled “Interactive Scheduling is Key to Successful Biomanufacturing Operations”

“Harvoni, a Hepatitis C Drug From Gilead, Wins F.D.A. Approval,” The New York Times

“The first complete treatment for hepatitis C that requires taking only a once-a-day pill won approval Friday from the Food and Drug Administration.”

If you like this story, please see our blog titled “Improving Clone Isolation and Screening In Hybridoma Cells – Moving away from Limiting Dilution”