Issue # 2523 | October 3rd, 2017      

 




































































































































































































News Alert



FDA Targets Complex Generic Drugs 
With New Draft Guidance

The U.S. FDA this week kicked off a two-day meeting on modernizing generic drug development and released two new draft guidance documents on complex generic drugs. FDA Commissioner Scott Gottlieb spoke at the meeting, highlighting recent moves to establish a list of off-patent drugs that will receive expedited approval if an abbreviated new drug application (ANDA) is submitted, as well as new plans to expedite the reviews of the first three generic drugs for which competition is lacking.  Gottlieb also called for the more widespread use of modeling and simulation in the generic space, in addition to the need to streamline complex generic reviews.  To learn more   click here , or on the logo above.




Merck Drops hep C Programs 
in 'Strategic Decision'

Merck & Co. has discontinued the development of two investigational combination regimens that were in testing for the treatment of chronic hepatitis C, citing its review of Phase 2 efficacy data and the current status of the marketplace. The two regimens being dropped are MK-3682B and MK-3682C, both of which contained the experimental uprifosbuvir. Merck said it will maintain its already-marketed hepatitis C offering Zepatier, a fixed dose combination of elbasvir and grazoprevir. This move doesn't come as entirely unexpected. In February, Merck wrote down the value of hepatitis C drug uprifosbuvir by $2.9 billion, recognizing the drugs' reduced commercial potential given the competitive nature of the market.  To learn more click here , or on the logo above.




Dynamk Capital Announces First Closing

Dynamk Capital has announced a first close for its venture fund providing early stage capital to innovative companies providing tools, technologies and services within the Life Sciences sector. The fund is on track for a final close in 2018 and expects to invest in 8-10 companies over the next several years. Dynamk's portfolio companies will provide technologies and services that enable biopharmaceutical companies around the world to develop therapeutics faster and produce them more economically. By focusing on enabling tools utilized across the industry, Dynamk's model leverages the growth of the several hundred billion-dollar biopharmaceutical industry, while mitigating risks inherent to therapeutics.  T o learn more  click here , or on the logo above.

Quote Alert



On this Day Alert



TED Alert

Everything You Hear on Film is a Lie


Sound design is built on deception -- when you watch a movie or TV show, nearly all of the sounds you hear are fake. In this audio-rich talk, Tasos Frantzolas explores the role of sound in storytelling and demonstrates just how easily our brains are fooled by what we hear. T o learn more click here , or on the image above.

Poll Alert

Will the tragic mass shooting in Las Vegas lead to stricter gun control laws in the U.S.?





Bioprocess Alert

Understanding Chemically Defined 
Media in Bioprocessing


This training video focuses on the importance of culture media in the overall cell culture development process, the critical components that comprise chemically defined media and reviews the evolution of culture media over time. T o learn more click here , or on the image above.

Market Alert



Event Alert: Conference



Regulatory Alert



FDA Grants Roche's Perjeta-Herceptin Combo Priority Review Status

The U.S. FDA has accepted Roche's supplemental Biologics License Application and granted Priority Review for Perjeta®, in combination with Herceptin® and chemotherapy. The FDA is expected to make a decision on approval by January 28th, 2018. The sBLA is based on results of the phase III APHINITY study. The combination of Perjeta, Herceptin and chemotherapy is licensed as a treatment method in more than 85 countries worldwide following approvals by the EMA and the U.S. FDA. In the U.S, the regimen is currently available under the FDA Accelerated Approval Program. This sBLA seeks to convert the current accelerated approval to full approval in the U.S. To learn more click here, or on the logo above.

Discovery Alert



Study Finds that Confronted with Bacteria, Infected Cells Die so Others Can Live

In a new study, a team of researchers led by Igor E. Brodsky of the University of Pennsylvania, identified a "back-up alarm" system in host cells that responds to a pathogen's attempt to subvert the immune system.  "In the context of an infection, the cells that are dying are talking to the other cells that aren't infected," said Brodsky, an assistant professor in the Department of Pathobiology in Penn's School of Veterinary Medicine and senior author on the study. "I don't think of it as altruistic, exactly, but it's a way for the cells that can't respond any longer to still alert their neighbors that a pathogen is present."  The findings address the long-standing question of how a host can generate an immune response to something that is designed to shut off that very response. A potential future application of this new understanding may enable the cell-death pathway triggered by bacteria to be harnessed in order to target tumor cells and encourage their demise.  The work appears in the Journal of Experimental Medicine.  T o learn more click here , or on the image above.


Project Alert



Utah Biotech Firm to Purchase Former Semiconductor Facility
 
Emerging biotechnology firm PolarityTE has announced its intention to purchase the 60-acre site that was formerly the Utah headquarters for Fairchild Semiconductor for approximately $21 million. Launched earlier this year, PolarityTE's proprietary platform allows the company's products to regenerate a patient's tissues using their own cells. The company will renovate much of the existing 300,000-square-foot building on the property at 3333 W. 9000 South to suit its various needs, including research and development, laboratory testing and corporate administration, explained President and CEO Denver Lough.  To learn more click here , or on the logo above.

Patent Alert



Thermostable, Chromatographically Purified
Nano-VLP Vaccine
 
A U.S. Patent Application for " Thermostable, Chromatographically Purified  Nano-VLP Vaccine"  w as published by the U.S. Army on  September 28th, 2017. The present invention is a method for preparing nano-VLP composition, thereby permitting purification using chromatography and filtration. The nano-VLP composition has a more uniform size range of filovirus particles, roughly 230 nm diameter, allowing ease of manipulation of the composition, while retaining GP conformational integrity and the antigenic effectiveness of the vaccine. Additionally, the nano-VLP can be lyophilized without loss of nano-VLP structure, or GP immunogenicity. Lyophilized nano-VLP have greatly enhanced thermostability, allowing the creation of a filovirus nano-VLP vaccine without a cold chain requirement. T o learn more  click here ,  or on the logo above.


Focus Alert



Computational Fluid Dynamics (CFD) Approach for Characterizing and Improving Fluid Flow for Membrane Filtration Technologies and Successful Scale-Up

There is increasing interest in using computational fluid dynamics (CFD) techniques to obtain better understanding of fluid dynamics of various unit operations, both upstream and downstream bioprocessing, and to use simulated results for process modelling, system characterization and design optimization. Membrane filtration technologies and in particular, tangential flow filtration (TFF), have made use of CFD analysis to gain better insight into, for instance, velocity and concentration profiles within channels, optimizing spacer geometry and configurations to maximize mass transfer for different TFF setups.

The applications and benefits for TFF processes are immense since large volumes of liquid are normally required, both for cleaning and processing, and thus even small increments in efficiency can result in significant cost reductions. In this study, a novel Ultra Scale-Down (USD) membrane filtration device and spacer-filled channels in TFF cassettes were modelled using COMSOL Multiphysics. 2D-axisymmetrical and 3D models were developed, respectively, to simulate the effect of geometry, design and hydrodynamic conditions on flow, wall shear rates and pressure profiles. Laminar flow and Shear Stress Transport (SST) formulations were used and parametric sweeps employed for different geometrical and design parameters. The geometrical configuration, such as clearance of the disc, cone angle and disc diameter, and the resulting hydrodynamics within the system was seen to play a vital role in wall shear rate distributions for the USD device.

To learn more click here   or on the image above.


Fact Alert



Job  Alert


Biogen is seeking to fill a  Scientist I, Purification Process Development  position at their site in Cambridge, Massachusetts. The successful candidate will join a team of engineers/scientists responsible for the development of purification processes used for the clinical and commercial manufacture of adeno-associated virus (AAV) vectors. This candidate will be involved in planning and execution of multiple aspects of viral vector purification, including chromatography, filtration and membrane separations.  To learn more click here , or on the  logo above.



Catalent Pharma Solutions is seeking to fill an Automation Engineer position at their site in Somerset, New Jersey. This position is responsible for providing technical support, coordination and expertise for new technology introductions, process and equipment automation, and other existing technologies at the Somerset site. To learn more click here, or on the logo above.



Sanofi is seeking to fill an Associate Scientist, Upstream position at their site in Framingham, Massachusetts. The Associate Scientist position is part of Process Science in Global Manufacturing Science & Technology (MSAT) and is based at the biologics hub in Boston. MSAT within Industrial Operations (IO) of Sanofi Genzyme Specialty Care assures robustness and economics of cell-culture based TMabs manufacturing process life cycle management (LCM). To learn more click here, or on the logo above.




Celgene is seeking to fill a Senior Scientist, Downstream Process Development position at their site in Summit, New Jersey. This Sr. Scientist position in Biologics Downstream Process Development will focus initially on a bispecific program, and be responsible for the development of scalable purification processes, for research and Tox material production, and for scale up and transfer of processes to GMP facilities for clinical manufacturing, towards IND submission by the year end of 2017. To learn more click here, or on the logo above.