Rubius Therapeutics Breaks Ground on $155M Biotech Site

                                                                                          Issue # 2776 | September 21st, 2018      










































































































































































































News Alert



Rubius Therapeutics Breaks Ground on $155M Biotech Site

Work is now officially underway on a new biopharma facility after several state officials gathered to break ground on the project this week. Once completed, the new Rubius Therapeutics facility will support 160 new jobs in manufacturing, biotech operations and other support functions. The company says it plans to invest up to $155 million over approximately five years to renovate an existing 135,000 square-foot building in Smithfield, Rhode Island. Rubius Therapeutics acquired the site from Alexion over the summer.  Learn More




BeiGene Selects GE's Off-the-Shelf Biologics Factory to Boost its Manufacturing Capacity

BeiGene has picked up  an 'off-the-shelf' biologics manufacturing plant from GE Healthcare to build its cancer monoclonal antibodies output. The prefabricated plant, part of GE's KUBio business, will be situated in Guangdong Province, China, with the first phase operational in 2019.  The relationship between GE Healthcare and BeiGene isn't a new one. The Chinese company is already using GE Healthcare's FlexFactory integrated biomanufacturing platform and single-use technologies to manufacture monoclonal antibodies for clinical trials at an  existing manufacturing plant in Suzhou, China Learn More




BioPharma's Raise Issues with FDA's Field Alert Report Submissions Guidance

GSK, Sanofi and Perrigo are calling on the U.S. FDA to make changes to its recently released draft guidance on field alert report (FAR) submissions. The draft guidance describes the FDA's current thinking on submitting FARs for new drug applications and abbreviated new drug applications. In the guidance, the FDA calls on applicants to submit a FAR within three working days of receiving information about certain issues relating to a product or its labeling, such as bacteriological contamination or deterioration.In comments the three drugmakers point out issues in the draft guidance and ask for more clarification from the agency.  Learn More

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TED Alert

How Our Friendship Survives Our Opposing Politics


Can you still be friends with someone who doesn't vote the same way as you? For Caitlin Quattromani and Lauran Arledge, two best friends who think very differently about politics, the outcome of the 2016 US presidential election could have resulted in hostility and disrespect. Hear about how they chose to engage in dialogue instead -- and learn some simple tactics they're using to maintain their bipartisan friendship.  Learn More

Poll Alert

Are there too few women in top executive business positions today?



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Bioprocess Alert

Ultrafiltration/Diafiltration (UF/DF): Managing Aggregates in Your Monoclonal Antibody (mAb) Process


In this video, which has 11,000+ views,  Emily Peterson, Senior Biomanufacturing Engineer, discusses how careful selection of operation conditions and Tangential Flow Filtration (TFF) system design impacts aggregate formation within the UF/DF process.

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Event Alert

 

CPV - Avoid Process & Equipment Deviations in Real-time
 
Wednesday, September 26th, 2018

For many facilities, continued process verification (CPV) is yet another quality requirement to adhere to. But what if CPV was a means to drive tangible improvements to manufacturing operations?
 
In this webinar, we'll show how CPV done right drives a deeper understanding of the relationship between parameters and product quality.  SmartFactory Rx has delivered Pharma CPV solutions that drive higher yield, better quality outcomes, and a greater knowledge about the process.

Join us to see how Applied's solutions can move your CPV program beyond quality requirement to right first time.


Resource Alert



Development of Capacitance Tools: At -line Method for Assessing Biomass of Mammalian Cell Culture and Fixed Cell Calibration Standard

Capacitance has been used to monitor "biomass" in cell culture and fermentation processes for several decades. The present work explored various ways to support GMP use and create robust methods that would assure proper performance of capacitance equipment. The first goal was to develop a method for measuring at -line capacitance that could serve to correct or confirm online measurements from bioreactors. With appropriate control of culture temperature, vessel geometry, mixing, and timing; an at -line system was developed that consistently predicted online capacitance outputs. The at -line method yielded values that differed systematically from online values...  Learn More

 
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Regulatory Alert



Third Form 483 Surfaces for China Company at Center of Valsartan Contamination

Just days after the U.S. FDA joined the EMA and Health Canada in announcing a second impurity, called NDEA, has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals the FDA has released a third Form 483 to the company. Following inspections in July and August, the FDA issued the 483 with 11 observations, with perhaps not surprisingly specific issues raised about the firm's quality unit. The FDA also found the firm's change control system, designed to evaluate all changes that may affect production to be inadequate.  Learn More

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