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Quality by Design for enabling RNA platform production processes
RNA-based products have emerged as one of the most promising and strategic technologies for global vaccination, infectious disease control, and future therapy development. The assessment of critical quality attributes (CQAs), product–process interactions, relevant process analytical technologies, and process modeling capabilities can feed into a robust Quality by Design (QbD) framework for future development, design, and control of manufacturing processes. QbD implementation will help the RNA technology reach its full potential and will be central to the development, pre-qualification, and regulatory approval of rapid response, disease-agnostic RNA platform production processes.
Pfizer-BioNTech’s (BNT162b2) and Moderna’s (mRNA-1713) vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are the first RNA-based biologics to be approved for human use and mass produced.RNA technology holds great promise beyond infectious disease prophylaxis, from cancer and gene therapy to treatments against cardiovascular and autoimmune diseases.Current production processes have been developed and scaled up at an unprecedented speed, mostly under a Quality by Testing paradigm.Recent research has highlighted a strong link between product and process development.The application of advanced analytical and modeling technologies could rapidly reshape and digitize manufacturing processes.
Journal Article
Interfaces in organic electronics
Undoped, conjugated, organic molecules and polymers possess properties of semiconductors, including the electronic structure and charge transport, which can be readily tuned by chemical design. Moreover, organic semiconductors (OSs) can be n-doped or p-doped to become organic conductors and can exhibit mixed electronic and ionic conductivity. Compared with inorganic semiconductors and metals, organic (semi)conductors possess a unique feature: no insulating oxide forms on their surface when exposed to air. Thus, OSs form clean interfaces with many materials, including metals and other OSs. OS–metal and OS–OS interfaces have been intensely investigated over the past 30 years, from which a consistent theoretical description has emerged. Since the 2000s, increased attention has been paid to interfaces in organic electronics that involve dielectrics, electrolytes, ferroelectrics and even biological organisms. In this Review, we consider the central role of these interfaces in the function of organic electronic devices and discuss how the physico-chemical properties of the interfaces govern the interfacial transport of light, excitons, electrons and ions, as well as the transduction of electrons into the molecular language of cells.
Organic semiconductors form clean interfaces with diverse materials, including metals, other organic semiconductors, electrolytes, dielectrics and biological organisms. In this Review, we discuss the properties of these interfaces and their central role in the function of organic electronic devices.
Journal Article
Do Incumbents Improve Service Quality in Response to Entry? Evidence from Airlines' On-Time Performance
We examine if and how incumbent firms respond to entry and entry threats using nonprice modes of competition. Our analysis focuses on airline service quality. We find that incumbent on-time performance (OTP) actually
worsens
in response to entry, and even entry threats, by Southwest Airlines. Since Southwest is both a top-performing airline in OTP and a low-cost carrier (LCC), we conjecture that this response by incumbents may be due to a cost-cutting strategy that allows for intense postentry price competition along with preentry deterrence, or it may be due to a postentry differentiation strategy along with preentry accommodation. Further analysis of entry and entry threats by other airlines is inconclusive, providing evidence that is partially consistent with both hypotheses. Nonetheless, the phenomenon of worsening OTP can only be observed when the (potential) entrant is a LCC (Southwest, Jet Blue, and AirTran).
Data, as supplemental material, are available at
http://dx.doi.org/10.1287/mnsc.2014.1918
.
This paper was accepted by by Bruno Cassiman, business strategy
.
Journal Article
PEDOT:PSS-based Multilayer Bacterial-Composite Films for Bioelectronics
Microbial electrochemical systems provide an environmentally-friendly means of energy conversion between chemical and electrical forms, with applications in wastewater treatment, bioelectronics, and biosensing. However, a major challenge to further development, miniaturization, and deployment of bioelectronics and biosensors is the limited thickness of biofilms, necessitating large anodes to achieve sufficient signal-to-noise ratios. Here we demonstrate a method for embedding an electroactive bacterium,
Shewanella oneidensis
MR-1, inside a conductive three-dimensional poly(3,4-ethylenedioxythiophene):poly(styrenesulfonate) (PEDOT:PSS) matrix electropolymerized on a carbon felt substrate, which we call a multilayer conductive bacterial-composite film (MCBF). By mixing the bacteria with the PEDOT:PSS precursor in a flow-through method, we maintain over 90% viability of
S. oneidensis
during encapsulation. Microscopic analysis of the MCBFs reveal a tightly interleaved structure of bacteria and conductive PEDOT:PSS up to 80 µm thick. Electrochemical experiments indicate
S. oneidensis
in MCBFs can perform both direct and riboflavin-mediated electron transfer to PEDOT:PSS. When used in bioelectrochemical reactors, the MCBFs produce 20 times more steady-state current than native biofilms grown on unmodified carbon felt. This versatile approach to control the thickness of bacterial composite films and increase their current output has immediate applications in microbial electrochemical systems, including field-deployable environmental sensing and direct integration of microorganisms into miniaturized organic electronics.
Journal Article
Jim Henson's Labyrinth : coronation
The untold origin of the Goblin King from Jim Henson's cult-classic film, Labyrinth. Long before Sarah ventured to save her baby brother from the clutches of the Goblin King, another young woman sought to save her child from an unknown fate within the Labyrinth. Set in 18th-century Venice, Jim Henson's Labyrinth: Coronation is a striking look into the mysteries of the Labyrinth itself, uncovering the fate of a small boy named Jareth who would one day be King. Simon Spurrier (The Spire, Jim Henson's The Power of the Dark Crystal) and Daniel Bayliss (Jim Henson's The Storyteller: Dragons, Big Trouble in Little China/Escape from New York) present a look into a magical world where nothing is as it seems and introduce Maria, a heroine instilled with courage, hope, and determination.
Book
Fully 3D-printed organic electrochemical transistors
Organic electrochemical transistors (OECTs) are being researched for various applications, ranging from sensors to logic gates and neuromorphic hardware. To meet the requirements of these diverse applications, the device fabrication process must be compatible with flexible and scalable digital techniques. Here, we report a direct-write additive process to fabricate fully 3D-printed OECTs, using 3D printable conducting, semiconducting, insulating, and electrolyte inks. These 3D-printed OECTs, which operate in the depletion mode, can be fabricated on flexible substrates, resulting in high mechanical and environmental stability. The 3D-printed OECTs have good dopamine biosensing capabilities (limit of detection down to 6 µM without metal gate electrodes) and show long-term (~1 h) synapse response, indicating their potential for various applications such as sensors and neuromorphic hardware. This manufacturing strategy is suitable for applications that require rapid design changes and digitally enabled direct-write techniques.
Journal Article