FDA Looks to Resume Domestic Inspections Next Week

                                                                                          Issue # 3240 | July 13th, 2020      




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News Alert


FDA Looks to Resume Domestic Inspections Next Week

Months after halting most inspections amid the coronavirus disease (COVID-19) pandemic, the US FDA has announced that it plans to resume on-site domestic inspections beginning the week of July 20th, 2020. As a safety measure, the FDA will pre-announce all inspections, save for retail tobacco inspections, for the foreseeable future. The announcement comes nearly two months after the agency said it will implement a phased approach to restarting surveillance inspections and four months after the agency halted its domestic inspection program. The FDA said it will prioritize which inspections it conducts in the coming months using a new risk assessment system to determine the state- and county-level risk posed by the virus. Learn More



BioNTech CEO Believes COVID-19 Vaccine Could be Ready for Approval by December

BioNTech Chief Executive Officer Ugur Sahin predicts the company's vaccine for COVID-19, which is it co-developing with Pfizer, could be ready for regulatory approval by the end of the year, with hundreds of millions of doses available for immediate distribution. In an interview with The Wall Street Journal, Sahin talked about the progress the companies have made on their vaccine candidate and said their manufacturing capabilities could provide about one billion doses of the preventative drug by the end of 2021. The vaccine candidate is expected to initiate Phase III studies by the end of this month with about 30,000 patients. Learn More



Blackstone Announces Successful Close of $4.6 Billion Life Sciences Fund

Blackstone has announced the final close of Blackstone Life Sciences V, their inaugural fund in Life Sciences, at $4.6 billion of total capital commitments - the largest life sciences private fund raised to date. Blackstone Life Sciences has three main investment strategies: strategic collaborations with established life science companies, late-stage product financings, and growth investments in emerging companies. Nicholas Galakatos, Ph.D., Global Head of Blackstone Life Sciences, said, "...With many more promising products in the life sciences industry's pipeline than capital available to advance them, we look forward to continuing to bring new treatment options and innovations to the patients who need them." Learn More
 
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On this Day Alert

1985  'Live Aid' Concert Raises $127 Million for
          Famine Relief in Africa



On this day in 1985, at Wembley Stadium in London, Prince Charles and Princess Diana officially open Live Aid, a worldwide rock concert organized to raise money for the relief of famine-stricken Africans. Continued at JFK Stadium in Philadelphia and at other arenas around the world, the 16-hour "superconcert" was globally linked by satellite to more than a billion viewers in 110 nations. Learn More

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TED Alert

Why We Should All Try Therapy


We tend to think of therapy as an approach to fixing problems - you go if you're not happy, not when everything seems fine. Clinical psychologist Emily Anhalt shares her experiences as both therapist and patient to make a compelling case that therapy isn't just a means to an end. "It'll drastically increase the depth and authenticity of your happiness," she says. "Making the necessary space for every feeling that lives in between." Learn More

Poll Alert

Within the last month, have you attended any in-person religious services/spiritual gatherings of more than 10 people?

Yes
No


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Bioprocess Alert

How to Transfer Suspension Cultures Between Differently Operated Shaking Platforms

 

Shaken cultures of suspension-adapted animal cell lines are still the method of choice for screening and small-scale culture experiments due to their easy handling, the simple and fast implementation in almost any laboratory environment and the possibility of cost-effective parallelization. However, on closer inspection, there are a few points that need to be considered and which play a major role in successful cultivation. Learn More

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Upstream Alert

The Use of Analytical Data to Make Process Decisions Presented by Cytovance Biologics

 

The development of a process to manufacture drugs for clinical studies requires the right analytical data to make the final process decisions. Some of the critical data used in making the decisions in microbial fermentations are the sugars (glucose/glycerol), acetate, and phosphate levels. The sugar levels help to determine the amount of feed needed at the growth rate of the cells. Excess feed results in the accumulation of acetic acid in the fermentation broth which is toxic to the cells. For processes where the induction mechanism involves the depletion of phosphate (PhoA process), the level of Phosphate in the media needs to be below a threshold for expression. This session discusses the analytical data that was generated to determine the final process to be used in cGMP manufacturing to produce clinical materials. Learn More

Event Alert



Webinar:  The Concept of Upstream Scaling - From Theory to Practice

Tuesday, July 21st, 2020

This educational webinar covers the concept of upstream bio process scaling, the importance of design space and bioreactor engineering towards scalability, followed by case studies on the successful implementation of certain scaling approaches.
 
The webinar concludes with an introduction of a novel scale conversion tool used for scaling parameters in a bioreactor-size-independent way to predict the best set of cell culture parameters for single-use, stirred tank bioreactors from development through to manufacturing scale.

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Downstream Alert

Versatile Modules Enable Automated Multi-Column Purifications on the ÄKTA Pure Chromatography System

 

Protein purification processes in basic research using ÄKTA™ liquid chromatography systems are often limited to single sample injections and simple one-column purifications. Because many target proteins in structural biology require complex purification protocols the work easily becomes laborious. To streamline and accelerate downstream protein production, an ALIAS™ autosampler and a modular sample in-line dilution process coupled to ion-exchange chromatography were incorporated into the workflow to automate two of the most commonly performed purification strategies - ion-exchange to size exclusion and nickel-ion metal affinity to size exclusion. Learn More

Podcast Alert
 
Remembering Live Aid



Live Aid was a revolutionary concert event in two countries in 1985 that spanned the world via satellite. The brainchild of musician Bob Geldof, it really did help change the world in many ways, but its direct impact on Ethiopian famine relief remains in question. Learn More

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Regulatory Alert

 

FDA Looks to Resume Domestic Inspections this Month