Copy
Newsletter/Marketing

Having trouble viewing this email? Click here

Aspen Alert

Issue # 3569 | October 28th, 2021      

   News Alert

Blood, Lies, and a Drug Trials Lab Gone Bad

The system for testing biopharmaceuticals in the US relies on contractors adhering to strict guidelines. But one of them chose profits over protocols. The email that Joe Hagood received in August 2017 was vague and brief, but too unsettling to ignore. Hagood worked at Medpace, a Cincinnati company that tests new drugs for pharmaceutical manufacturers. His job was to supervise the independent research centers that Medpace pays to handle the nitty-gritty of human trials: finding volunteers, dispensing medications, tracking side effects. The author of the unsettling email, Justina Bruinekool, was a staffer at one of those centers. She claimed to have an urgent reason for writing: Her employer was fraudulently conducting a major trial that Hagood was overseeing.
Learn More

BioPharma’s Undercut Rivals with New Patent Tactic as Law Shifts

BioPharma companies are turning to a fast-moving but rarely used patent office process to undercut their competitors’ intellectual property. Drugmakers, in a slow but steady trend, are considering post-grant reviews, a Patent and Trademark Office trial proceeding where a wide array of challenges can be brought against rivals’ drug patents. The number of post-grant reviews challenging standard drug and biologic patents rose from just one in 2014 to 10 in the first half of 2021. For companies that closely watch their competition, post-grant reviews present an effective way to narrow the number of patents they have to clear to get a product to market. That is especially true since case law has evolved to favor challenges that can’t be brought under the PTO’s more popular inter partes review process.
Learn More

Enzyvant Therapeutics Granted Priority Review Voucher by US FDA

The US FDA has announced the issuance of a priority review voucher to Enzyvant Therapeutics for its drug RETHYMIC (allogeneic processed thymus tissue-agdc). These FDA's vouchers, of which there are three types, are incentives meant to spur the development of new treatments for diseases that would otherwise not attract development interest from companies due to the cost of development and the lack of market opportunities. In this instance the priority review voucher in question relates to a rare pediatric disease. No word yet on whether Enzyvant has plans to utilize the voucher or sell it. As recently as earlier this year a priority review voucher was sold for $100 million to Alexion.
Learn More

ADVERTISEMENT

Learn More

   Quote Alert

   On This Day Alert

St. Louis's Gateway Arch is Completed 

On this day in 1965, construction is completed on the Gateway Arch, a spectacular 630-foot-high parabola of stainless steel marking the Jefferson National Expansion Memorial on the waterfront of St. Louis, Missouri. The Gateway Arch, designed by Finnish-born, American-educated architect Eero Saarinen, was erected to commemorate President Thomas Jefferson’s Louisiana Purchase of 1803 and to celebrate St. Louis’ central role in the rapid westward expansion that followed.
Learn More

ADVERTISEMENT

Learn More

  TED Alert

How Science Has Driven Our Technology And Economy 

For the last half millennium, scientific curiosity has driven a series of technological revolutions that powers today’s economy and dominates our way of life. About 500 years ago, studies of the motions of the planets and Moon led to mechanics. Mechanics led to the Industrial Revolution. Investigation of electricity, magnetism, and atoms led to the electrification of the planet, computers, cell phones, and a host of modern gadgets. Science now dominates the human experience. Where will today’s discoveries take us in the future?
Learn More

  Poll Alert

Which one of the following is your preferred way to interact with your bank?

► In Person
► Remote

Previous Poll Results:

ADVERTISEMENT

Learn More

  Bioprocess Alert

Osmolality as a Concentration Measurement Method for Key Buffers in Bioprocessing

Osmolality has been evaluated in this study as an orthogonal measurement with the potential to add consistency and improved control strategy for bioprocesses. Osmolality is a measurement of the moles of solute per kg of water, and therefore is expected to be relatively unaffected by the type of molecule, the degree of ionization, or the pH. This study was conducted to understand how osmolality can serve as a concentration measurement and how it compares to pH and conductivity measurements.
Learn More

View More

Survey Alert

When evaluating bioprocess controllers, what are you most interested in obtaining? Please comment on your reason(s).

► Ease of Use
► Configurability
► Reliability
► Other

Previous Survey Results:

ADVERTISEMENT

Learn More

  Upstream Alert

Taking the Pulse of Bioprocesses: At-Line and In-Line Monitoring of Mammalian Cell Cultures

Real-time and near real-time monitoring of cell culture processes are critical to the evolving process analytical technology (PAT) paradigm for upstream bioprocessing. The responses measured from these analytical instruments can enable rapid feedback to perturbations that can otherwise lead to batch failures. Historically, real-time monitoring of bioreactor processes has been relegated to parameters such as pH, dissolved oxygen, and temperature. Other analytical results, such as cell growth and metabolites, are provided through manual daily sampling. Here we discuss recent advances in these technologies. This article aims to focus on other developing at-line and in-line technologies that enable monitoring of bioreactor processes, including dielectric spectroscopy, NIR, off-gas spectrometry, integrated at-line HPLC, and nanofluidic devices.
Learn More

View More

Event Alert

From Gene to Patient

Tuesday, November 16, 2021

At this one-day virtual event, experts and key opinion leaders in the areas of upstream processing, downstream processing, and analytics related to viral vectors and the gene therapy journey will share their insights. In addition to lectures, the event will provide a platform to facilitate networking and discussions with other experts in the field, including during meet-the-speaker sessions and coffee breaks. There is also the possibility for participants to register for a 1:1 meeting with a Sartorius expert.
Learn More

ADVERTISEMENT

Learn More

 Downstream Alert

Quantitative Interpretation of Protein Breakthrough Curves in Small-Scale Depth Filter Modules for Bioprocessing

Depth filters are used throughout downstream bioprocessing, with specialized filter chemistries developed for removal of host cell proteins, DNA, and protein aggregates. These filters often show very broad breakthrough curves, but there have not been any previous analyses of this phenomenon. Protein breakthrough curves were evaluated for Ribonuclease A and α-chymotrypsin in two small-scale depth filter modules using PDH4 media containing diatomaceous earth. Computational fluid dynamics (CFD) simulations were developed, with flow in the porous media described using the modified Navier-Stokes equations incorporating a Brinkman flow term and a Langmuir binding model.
Learn More

  Podcast Alert

Harry Houdini: More Than Magic

Harry Houdini was a master magician. He was also a movie star. And an inventor. And an aviator. Listen and learn all about the late great illusionist.
Learn More

ADVERTISEMENT

Learn More

  Fill/Finish Alert

How Do Your Freezing Choices Affect Your Drug Substance?

As freezing drug substance for storage and transport becomes ever more important, learn more about how freezing kinetics affect product quality. Discover how conventional, static freezing in bottles or bags inhibits activity retention and affects product stability, plate freezing helps minimize viability losses and extend shelf life and rapid thawing can reduce molecule degradation.
Learn More

View More

  Regulatory Alert

ICH Q12 Guideline Draws More Comments from Industry

A major pharmaceutical industry group is calling for the US FDA to institute several revisions to the ICH Q12 guideline on post approval changes. The document was released by the FDA for public feedback in May. The ISPE suggested in its October 8 comments that proposed reporting categories should be placed in the regional section and not module 3 of the Common Technical Document (CTD), where quality information is placed. The group asserted that putting the reporting category in module 3 would lead to “regulatory divergence” since not all regulators plan to incorporate ICH Q12 in their regulatory frameworks.
Learn More

ADVERTISEMENT

Learn More

  Discovery Alert

New Computer Modeling Could Boost Drug Discovery

Scientists from Queen's University Belfast have developed a computer-aided data tool that could improve treatment for a range of illnesses. The computer modelling tool will predict novel sites of binding for potential drugs that are more selective, leading to more effective drug targeting, increasing therapeutic efficacy and reducing side effects. The data tool or protocol will uncover a novel class of compounds -- allosteric drugs in G protein-coupled receptors (GPCRs). Recent studies point to the existence of other binding sites, called allosteric sites that drugs can bind to and provide several therapeutic benefits. However, the discovery of allosteric sites and drugs has been mostly serendipitous.
Learn More

  Project Alert

Catalent Investing $230M to Expand in Maryland

Catalent announced a year ago it was putting up $130 million to expand its facility in Harmans, Anne Arundel County, near Baltimore-Washington International Thurgood Marshall Airport. The New Jersey-based company announced this week it will spend an additional $230 million to expand its gene and cell therapy manufacturing suites and support facilities. The move is expected to bring more than 700 additional jobs to the greater Baltimore region, an area that continues to expand its biotech footprint. The campus currently has a state-of-the-art FDA approved facility with 10 commercial-scale manufacturing suites.
Learn More

ADVERTISEMENT

Learn More

  Patent Alert

Purification of Virus Like Particles

A U.S. Patent for "Purification of Virus Like Particles" was awarded to Takeda on August 17, 2021. The present invention addresses methods of purifying virus-like particles (VLPs) that are substantially free of process contaminants and infectious agents. The methods incorporate, for example, low-pH treatment during harvest and/or inactivation by a solvent and/or detergent during VLP capture.
Learn More

  Solution Alert

Polar Integrations

IDBS Polar provides out-of-the-box integrations combined with out-of-the-box workflows to significantly reduce the time and complexity of implementation. Powered by the Digital Lab Exchange (DLXTM) platform, Polar workflows ensure data integrity and drive strategic insight through a comprehensive, vendor-neutral strategy based on a modern cloud-based architecture with robust security, compliance, and laboratory-specific functionality.
Learn More

View More

ADVERTISEMENT

Learn More

  Humor Alert

  Fact Alert

How A Baby Owl Sleeps

Baby owls sleep on their stomachs because their heads are too heavy. They do so until they are large enough to sleep upright.
Learn More

ADVERTISEMENT

Subscribe

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   Career Alert

Bristol Myers Squibb
Senior Bioprocess Associate I, Digital Plant Support Role
Syracuse, NY
The Senior Bioprocess Associate I is a senior member of a team and will be leveraged to ensure compliance with cGMP requirements, safety, and production schedule of junior staff. Job duties will consist of about a 50/50 split between mfg. process work and Automation support activities. Learn More

YMC America
Technical Sales Manager – Chromatography
Remote, Mid-Atlantic/Northeast U.S. Territories
As Technical Sales Manager - Chromatography, you will promote and sell YMC liquid chromatography products to biotech, pharma, and academic accounts in the Mid-Atlantic/Northeast U.S. territories. Learn More

YMC America
Automation Engineer – Software
Devens, MA
Automation Engineer will develop, implement, and test automation/control solutions for our products. This position is customer driven and focused and is responsible for working with current and potential clients/customers. Learn More

Brooks Instrument
Industrial Account Manager (New England Territory)
New England Area
Manage the direct sales to key accounts in the New England territory to achieve short-term and long-term business objectives. Learn More

Aspen Media, Inc.
Contact

My Account
Login
Custom Notifications
Favorites

Aspen Alert
Past Issues
Subscribe

Aspen Atheneum
Archive

Aspen Marketplace
Aspen Events Calendar
Aspen Career Center

Contribute

Aspen Atheneum
Aspen Events Calendar
Aspen Career Center
Aspen Surveys

Privacy Center
Privacy Policy
Terms of Use
Do Not Sell My Personal Info

Follow Us On Social Media!

 POWERED BY ASPEN MEDIA, INC. © COPYRIGHT 2021