UK High Court Invalidates Two AbbVie Patents For Humira In Win For Samsung

                                                                                          Issue # 2471 | July 20th, 2017      


News Alert

GSK Cancels Planned $450M Investment 
in Ulverston U.K. Site Amid Talks of Sale

GSK has made public its decision not to move forward with a $450M investment in its Ulverston, U.K. site amid reports that the company intends instead to seek a buyer for the site. At the same time, the biopharma giant has announced that it will outsource some of the manufacturing work at its site in Worthing, U.K. This news comes as GSK conducts a strategic review of its antibiotics business. However, amid all the negative news GSK let it be known that it will invest roughly $180M across three of its manufacturing sites in the U.K. over the next several years. These include the Barnard Castle facility which will receive roughly $50M with which to upgrade its manufacturing equipment and associated technology.  T o learn more click here , or on the logo above.


Novartis CEO Focused on Deals Valued at $2B to $5B Amid Ongoing Rise in Biopharma Valuations

Novartis CEO Joe Jimenez, speaking on a company earnings call this week, noted that Novartis remains focused on bolt-on acquisitions ranging from $2B to $5B in size. However, he was quick to point out that finding value in that price range has proven elusive. As a result, he noted that Novartis is increasingly focusing its acquisition efforts further upstream in company's whose efforts are in early stage drug development. During the call Mr. Jimenez made a point of noting that high value acquisitions, in the $10-$15 billion range simply were not on his radar as of this moment.  T o learn more  click here , or on the logo above.

Vertex Reports Favorable Data 
from Cystic Fibrosis Trial

Shares of Vertex soared to a record high this week after the drugmaker revealed favorable data on its triple combinations of cystic fibrosis (CF) treatments. Vertex's shares climbed 26 percent, adding nearly $8 billion to its market valuation. Analysts said the data exceeded expectations, raised the bar for competitors and positioned the treatments to help up to 90 percent of patients with the life-shortening lung disease. Vertex already sells two therapies that can treat up to 40 percent of CF patients. Kalydeco and Orkambi.  The data this week showed three different triple combinations of CF treatments significantly improving patient lung function in clinical trials.  T o learn more click here , or on the logo above.

Quote Alert

On this Day Alert

Poll Alert
Do you agree with the practice of celebrity's and athletes charging money for autographs ?

TED Alert

The Simple Power of Handwashing

Myriam Sidibe is a warrior in the fight against childhood disease. Her weapon of choice? A bar of soap. For cost-effective prevention against sickness, it's hard to beat soapy hand-washing, which cuts down risk of pneumonia, diarrhea, cholera and worse. Sidibe, a public-health expert, makes a smart case for public-private partnerships to promote clean hands and local, sustainable entrepreneurship.  T o learn more click here , or on the image above.

Market Alert

Which of these upstream bioprocessing solutions is  most likely to be largely obsolete within the next 5  years?

Bioprocess Alert

The Impact of Aeration on Cell Culture in Bioreactors, Part 1

This training video is part 1 of a tutorial on the impact of aeration on cell culture production and discusses optimizing the delivery of oxygen to the cells and the rate limiting factors that can impact this critical aspect of bioproduction.  T o learn more   click here , or on the image above.

Event Alert: Course

VISION: Executive Leadership Training
for the Bio Industry

Wednesday, October 4, 2017 - Friday, October 6, 2017

In rapidly evolving technology driven bioindustries, leaders are facing challenging tasks of developing and adapting to new business models, identifying cutting edge research which can cost effectively translate to production level, devising and implementing strategies that can be implanted within the global regulatory, marketing and socio-political landscapes. VISION is a leadership course uniquely tailored for the bioindustry to capture the synergies between bioscience, technology and business practice.

UCL Biochemical Engineering in collaboration with Keck Graduate Institute is announcing its 2017 VISION Leadership Program. Designed for talented high impact individuals, VISION provides executive leadership insights tailored for present and future leaders in the bioindustries through rigorous intellectual analysis and intensive, practical, peer-to-peer action-based learning giving you the tools required to drive innovation, entrepreneurship and global leadership in your organization.
For more information on VISION, please click HERE.

Focus Alert

The Standardization of Single-Use 
Components for Bioprocessing

As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization. While the standardization discussion encompasses many topics (including how products are tested, assembled, etc.), components are a critical area for improvement. With so many ways to apply single-use and hybrid bioprocessing systems, organizations must take action to standardize equipment in order to streamline operations and help reach the full potential of the technology. By focusing on the most versatile genderless connectors, component standardization will help bioprocessing companies make the best use of single-use technology. The right connectors will enable end users to: 
  • Streamline operations with easy-to­use, robust sterile connections
  • Eliminate potential ordering mis­takes and reduce inventory demands related to gendered connectors
  • Maintain more flexibility and lessen production bottlenecks with onsite connector assembly
  • Reduce overhead costs, freeing up capital for other projects
Ultimately, standardizing components by incorporating single-use genderless connectors lets end users accomplish more with fewer finished goods, saving time and money, and getting their biopharmaceutical products to market more efficiently.  To learn more click here  or on the logo above.

Project Alert

Alcami Moving Global Headquarters 
to Durham, North Carolina

Alcami has announced plans to transition its global headquarters to Durham, North Carolina. According to company officials, the decision to expand Alcami's presence within Research Triangle Park (RTP) reinforces its commitment to the ongoing innovation and growth within the region. Alcami employs approximately 50 people at its current Durham laboratory services site and anticipates adding critical new jobs to support its technology expansion into biologics and establishment of its new headquarters location in 2018. The company will continue to house executive offices in both its current Wilmington, North Carolina, headquarters and Durham facilities until the full transition is complete.  To learn more click here , or on the logo above.

Regulatory Alert

First Gene Therapy Could Debut 
in the U.S. Market this January

Spark Therapeutics has announced this week that its application for approval for its gene therapy for blindness has been accepted by the U.S. FDA. The company has been given a user fee goal date of January 12th, 2018 for voretigene neparvovec, which is expected to be marketed as Luxturna. The drug is a potential one-time treatment, verging on a cure, for a rare genetic form of blindness caused by a gene mutation. There have been a small handful of gene therapies approved in Europe, but they have not performed well commercially. The industry is still trying to find a pricing model that could work for a one-time, potentially curative treatment. To learn more click here, or on the logo above.

Discovery Alert

Macrophages Made to Engulf 
Cancer Cells in Solid Tumors

Researchers at the University of Pennsylvania School of Engineering and Applied Science and Penn's Perelman School of Medicine and Physical Sciences Oncology Center have learned how to re-engineer macrophages, the "first responders" of the immune system, so that they can distinguish between healthy and cancerous cells. Armed with this ability, the engineered cells were able to circulate through the body of a mouse, invade solid tumors and specifically engulf human cancer cells therein. This represents a potential advance in cancer immunotherapy, which has so far found the greatest success in treating "liquid" tumors associated with blood cancers. The work was published in the journal Current Biology.  T o learn more click here , or on the image above.

Patent Alert

Protein Purification Using Displacement Chromatography

A U.S. Patent for " Protein Purification Using Displacement Chromatography"  w as awarded to AbbVie on July 18th, 2017The present invention is a method for producing a low acidic species human anti-TNF.alpha. antibody composition comprising a human anti-TNF.alpha. antibody, or antigen-binding portion thereof, wherein the human anti-TNF.alpha. antibody, or antigen-binding portion thereof, comprises a light chain variable region (LCVR) having a CDR1 domain, a CDR2 domain, and a CDR3 domain of adalimumab; and a heavy chain variable region (HCVR) having a CDR1 domain, a CDR2 domain, and a CDR3 domain of adalimumab, the method comprising: (a) contacting a first composition comprising the human anti-TNF.alpha. antibody, or antigen-binding portion thereof, with a chromatography media, wherein the first composition comprises more than 10% total acidic species of the human anti-TNF.alpha. antibody, or antigen-binding portion thereof; wherein the acidic species of the human anti-TNF.alpha. antibody, or antigen-binding portion thereof, comprise species selected from the group consisting of charge variants, structure variants, fragmentation variants, and any combinations thereof, wherein the acidic species of the human anti-TNF.alpha. antibody, or antigen-binding portion thereof, do not include process-related impurities selected from the group consisting of host cell proteins, host cell DNA, and media components, and wherein the human anti-TNF.alpha. antibody, or antigen-binding portion thereof, binds to the chromatography media; (b) displacing the human anti-TNF.alpha. antibody, or antigen-binding portion thereof, bound to the chromatography media with a displacing buffer; and (c) collecting a second composition comprising the displaced human anti-TNF.alpha. antibody, or antigen-binding portion thereof, wherein the second composition comprises less than 10% total acidic species of human anti-TNF.alpha. antibody, or antigen-binding portion thereof, thereby producing a low acidic species human anti-TNF.alpha. antibody composition.  To learn more,  click here  or on the logo above.

Fact Alert

Job  Alert

LEWA Bioprocess Technologies Group has an opening for a Bioprocess Systems Sales Specialist in the territory of New England & New York. This position plays a crucial role in the growth of the innovative bioprocess focused technologies of LEWA - Nikkiso. As part of a global company with over 5,000 employees we operate around the world and have built a global reputation for unparalleled quality, dependability, and exquisite engineering that's driven by market needs. To learn more click here, or  on the  logo above.

WMFTG seeks to fill a product validation specialist position. A primary objective of this role is to facilitate the implementation of common group strategies around the management of change control, product compliance and equipment validation processes within WMFTG. This role will be located either in East coast USA or UK.  T o learn more click here, or on the logo above.

GEMU is seeking to fill the following positions on the East and West Coast of the United States. To learn more about these positions click on the associated job link below;