Lonza to Build Biologics Manufacturing Facility in China

                                                                                          Issue # 2833 | December 11th, 2018      











































































































































































































News Alert



Lonza to Build Biologics Manufacturing Facility in China

The Swiss contracting giant Lonza is partnering with GE Healthcare to build a manufacturing facility in China for biologic drugs, the contract development and manufacturing organization said Monday. The plant will be roughly 180,000 square feet and employ 160 workers. Lonza expects to be manufacturing out of the site by 2020. The facility, which will focus on antibodies, will be in Guangzhou, a port city northwest of Hong Kong in southern China. The agreement falls within a broader deal GE Healthcare has with the city's economic development zone, called the Guangzhou Development District. Learn More




Gilead Selects Roche Veteran as New CEO, Roche Promotes Genentech Chief to Lead Pharma Division

Gilead has announced that longtime Roche veteran Daniel O'Day will assume the role of Chairman and CEO at Gilead beginning on March 1st, 2019. This comes as current Gilead CEO, John Milligan and Chairman John Martin, leave the company at the end of this year. In related news, Roche has announced the appointment of Bill Anderson, currently head of its Genentech unit, to lead its Pharma division. These changes come at a critical time for both company's as they look to navigate a rapidly evolving biopharma market full of challenges and opportunities. Learn More




Boehringer Ingelheim Plans to Cut About 300 Jobs in France
 
Boehringer Ingelheim told unions this week that it plans to cut some 300 jobs in France as part of efforts to reorganize activities around its hub in Lyon following an asset swap with Sanofi. Boehringer Ingelheim's chairman for France, Jean Scheftsik de Szolnok, has said that the company was planning to cut up to 327 jobs out of a 2,800 workforce in France. However, it will also create 32 new positions. He said the plan was to offer voluntary departure packages to avoid forced exits, but added that it was too early to give a timeframe. Alert readers will recall that Boehringer agreed in January of last year to trade its consumer health division in exchange for France's Sanofi animal health arm Merial in a $20 billion transaction. Learn More

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Want to Get Ahead? Be Paranoid


Lars F├Žste helps CEOs transform their businesses and over the years he's noticed something troubling: managers tend to get comfortable during times of success and fail to be on constant lookout for ways to grow. Yet with today's unprecedented rate of change, constant transformation is the norm and adapting to it is the key to staying ahead of competition and volatile market trends. In other words: if it ain't broke, fix it. Learn More

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How much confidence do you have in Russian President Vladimir Putin to do the right thing regarding world affairs?
 



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Bioprocess Alert

Introduction to Viral Safety Part 4 - Low pH Inactivation


This video provides an introduction to the role of low pH inactivation as an element of viral safety.

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Ensure Integrity of Single-Use Systems for Vaccines Sterile Processing
 
Webinar - Tuesday, December 11th 2018

One of the main challenges when considering single-use technologies in sterile vaccines processing is to ensure the highest level of assurance of integrity and sterility. This requires a strong collaboration and shared responsibility between the supplier and the end-user.

This webinar will develop the Quality by Design (QbD) aspects contributing to the assurance of integrity of Single-Use Systems (SUS) in the context of sterile vaccines processes. This will be presented from both an enduser's perspective (GSK) and a supplier's perspective (Pall).

Participants will learn:
  • The importance of interactions between suppliers and endusers for SUS implementation
  • How to manage sterility assurance concerns
  • How to assess and define the most appropriate mitigation strategy

Resource Alert



High-Efficiency Affinity Precipitation of Multiple Industrial mAbs and Fc-Fusion Proteins from Cell Culture Harvests Using Z-ELP-E2 Nanocages

Affinity precipitation using Z-elastin-like polypeptide-functionalized E2 protein nanocages has been shown to be a promising alternative to Protein A chromatography for monoclonal antibody (mAb) purification. We have previously described a high-yielding, affinity precipitation process capable of rapidly capturing mAbs from cell culture through spontaneous, multivalent crosslinking into large aggregates. To challenge the capabilities of this technology, nanocage affinity precipitation was investigated using four industrial mAbs (mAbs A-D) and one Fc fusion protein (Fc A) with diverse molecular properties. Learn More

 
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Regulatory Alert



FDA Flags Pfizer's Hospira Plant in Kansas Over Repeat 483 Citations

An inspection by the U.S. FDA at the McPherson, KS plant of Pfizer's Hospira business revealed eight repeat FDA Form 483 citations dating back to 2012. FDA investigators conducted an inspection of the human sterile drug manufacturing site from late July to early August 2018, with the agency posting the Form 483 to its website late last week. The latest 483 comes after Hospira's Kansas plant drew an FDA warning letter last year, with significant violations of good manufacturing practices, such as an inadequate investigation into the detected presence of cardboard in vial samples.  Learn More

Discovery Alert



Early Clinical Trial Data Shows Gene Therapy Reversing Sickle Cell Anemia