White House Proposes Narrowing the FDA's Mission and Renaming the Agency

                                                                                          Issue # 2711 | June 22nd, 2018      

















































































































































































News Alert



White House Proposes Narrowing the FDA's Mission and Renaming the Agency

The Trump administration has proposed a fundamental change to the mission of the U.S. Food and Drug Administration, one that would transfer most of the responsibility for regulating food safety to the Department of Agriculture and rename the FDA the "Federal Drug Administration." The idea of changing a key mission of the FDA comes amid a turf war between the FDA and the USDA. The two agencies have recently battled over who gets to regulate lab-grown meat, Politico reported last week. And in May, FDA Commissioner Scott Gottlieb spoke about the importance of his agency regulating genetically engineered animals.  Learn More




PIC/S Adopts New Guidelines on Shared Facilities, Revisions to GMP Guide

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has adopted new guidelines on cross-contamination in shared facilities and implemented revisions to several of the sections in its good manufacturing practices (GMP) guide.Both the guidelines and the revisions are intended to further regulatory harmonization between PIC/S and EU recommendations. They are also both set to enter into force on 1 July 2018. The new PIC/S Aide-Memoire and PIC/S guidelines cover a formalized risk-based GMP assessment on excipients of medicinal products, health-based exposure limits to aid GMP inspectors in identifying risk when manufacturing different products in shared facilities, and principles for good distribution practice.  Learn More




CellGenix Completes First Step in Facility Expansion to Meet Demand for GMP Cell Culture Reagents

CellGenixhas successfully completed the first phase of its headquarters' expansion as more customers approach late-stage clinical development and commercialization. In a first step, the company added additional space to its HQ site in Freiburg, Germany. This incldued the addition of QC and R&D labs, as well as logistics and warehouse space. As the next step, a state-of-the-art, automated filling and freeze-drying line will be implemented in the existing GMP facility increasing finished product capacity for recombinant proteins by more than tenfold. This second phase of expansion is expected to be completed in the spring of 2019.  Learn More

Quote Alert



On this Day Alert



TED Alert

The Dawn of De-Extinction. Are You Ready?


Throughout humankind's history, we've driven species after species extinct: the passenger pigeon, the Eastern cougar, the dodo ... But now, says Stewart Brand, we have the technology (and the biology) to bring back species that humanity wiped out. So -- should we? Which ones? He asks a big question whose answer is closer than you may think. 

Poll Alert

Should marijuana be legal?
     



Bioprocess Alert

Sterile Cell Culture Technique


This video, which has 125,000+ views, is a demonstration of sterile animal cell culture technique developed for the University of Manchester, School of Materials.  Learn More

Market Alert



Event Alert: Webinar



Accelerating Viral Vector Development and Production Using a Single-Use Platform

Tuesday, June 26th, 2018

This webinar will give you an overview of Sartorius' platform approach to process development. This approach allows companies to reduce the time required to bring their products to the clinic and to market while providing them with consistent process performance. The presenter will describe the toolbox of technologies and services proven to be efficient in the development, production and analysis of viral vector processes. The performance of a single-use viral vector platform will be illustrated by a case study based on adenoviruses.
 
Spotlight Alert



Inhibition of Apoptosis Using Exosomes in Chinese Hamster Ovary Cell Culture

Herein, we showed for the first time that exosomes, which are nano-sized extracellular vesicles, derived from CHO cells inhibited apoptosis in CHO cell culture when supplemented to the culture medium. Flow cytometric and microscopic analyses revealed that substantial amounts of exosomes were delivered to CHO cells. Higher cell viability after staurosporine treatment was observed by exosome supplementation (67.3%) as compared to control (41.1%). Furthermore, exosomes prevented the mitochondrial membrane potential loss and caspase-3 activation, meaning that the exosomes enhanced cellular activities under pro-apoptotic condition...  Learn More

 
Regulatory Alert



FDA Withdraws Guidance on Biosimilar Analytical Studies

In response to industry concerns, the U.S. FDA this week announced it has withdrawn its draft guidance on evaluating studies used to demonstrate analytical similarity between a biosimilar and reference biologic.The FDA says it plans to reissue the draft guidance after considering changes to the document that will "promote a more efficient pathway for the development of biosimilar products."To date, the FDA has approved 11 biosimilars to eight reference biologics since approving its first biosimilar in 2015. However, only a fraction of those biosimilars are available on the market, with legal challenges often adding years between approval and commercial launch.  Learn More

Discovery Alert



Targeting the Engine Room of the Cancer Cell

Researchers at Columbia University Irving Medical Center (CUIMC) have developed a highly innovative computational framework that can support personalized cancer treatment by matching individual tumors with the drugs or drug combinations that are most likely to kill them. The study, published this week on Nature Genetics, by Dr. Andrea Califano of Columbia University Irving Medical Center and Dr. Irvin Modlin of Yale University and Wren Laboratories LLC, co-senior author on the study, with collaborators from 17 research centers worldwide, details a proof of concept for a novel analytical platform applicable to any cancer type. 


Project Alert



Vertex Opens Expanded Research Site in San Diego

Vertex this week announced the opening of its new 170,000 square foot research facility in Torrey Pines, San Diego. The new site, located at 3215 Merryfield Row, represents a significant expansion of the Company's research presence in the area. The San Diego site is where the Company's three breakthrough cystic fibrosis (CF) medicines were discovered. More than 70 percent of the new facility is dedicated to state-of-the-art lab and research space. It features a 1,500 square foot learning lab and a 4,000 square foot incubator suite for external collaboration.  Learn More

Patent Alert



Coriolis Flow Meter for Measuring Properties of a Fluid and Method Therefor

A U.S. Patent Application for a "Coriolis Flow Meter for Measuring Properties of a Fluid and Method Therefor"
was published by GE on June 21st, 2018The present invention is a coriolis flow meter for measuring one or more properties of a fluid is described herein which involves a modular configuration, and includes a fluid flow sub-system and a mechanical oscillator sub-system, both functionally separate, and are coupled in a closed loop arrangement, such that the flow conduit is not directly vibrated, and instead receives induced oscillations from the mechanical oscillator sub-system. Learn More


Xchange Alert



Implementation of Fully Integrated Continuous Antibody Processing: Effects on Productivity and COGm

To date, integrated continuous bioprocessing has not been realized as enabling technologies are nascent. In this work, a fully integrated continuous process is successfully demonstrated from pilot scale bioreactor to drug substance. Comparable product quality is observed between the continuous process and a 500 liter fed-batch conventional process. A throughput analysis shows that a fed-batch facility with four x twelve five hundred liter liter stainless steel bioreactors and purification train of the corresponding scale can be replaced by a continuous facility consisting of five x two thousand liter single use bioreactors and smaller purification train, with a cost reduction of 15%.  Learn More


Career Alert
 
Skokie, IL.

New England Biolabs
Ipswich, MA.

Pfizer
Guayama, Puerto Rico


Fact Alert

Ferret Means "Little Thief"


A group of ferret's is called a "business". If excited, they perform a behavior called the "weasel war dance".  Learn More