Chemistry Commons^™

Achieving Warranted Acceptance Of Biotechnologies, Emily Grayek, Baruch Fischhoff

Level 3

The U.S. has faced long-standing shortages of generic drugs, causing negative health effects and spikes in drug costs. To address these shortages, investments in critical technologies and policies to support their adoption will be needed. The success of these technologies and policies depends on public acceptance. We studied public acceptance using the mental model approach, which identifies gaps in understanding that can be addressed with communications. We began with semi-structured interviews with experts in pharmaceutical manufacturing. Based on these interviews, we developed and conducted surveys of the general public, physicians, and pharmacists. Similar strategies could be applied to improve communications …

Valerie Mulholland On Improving Rbdm Effectiveness, Valerie Mulholland

Level 3

No abstract provided.

Agenda From June 1st Conference

Level 3

No abstract provided.

Speaker Bios

Level 3

No abstract provided.

Ipq Descriptor

Level 3

No abstract provided.

Hpra’S Kevin O’Donnell On The Ich Q9 Revision And Considerations For Its Implementation, Kevin O'Donnell

Level 3

At the June 2023 PRST meeting on the ICH Q9 revision, HPRA Market Compliance Manager and Senior GMP Inspector Kevin O’Donnell, who has been serving as rapporteur for ICH Q9 (R1), addressed the changes introduced in the revision, the practicalities of implementation, and his “personal thoughts” on the implementation process. Click here for ICH Q9(R1) with the changes highlighted by O’Donnell, and here for the slides accompanying O’Donnell’s remarks. Formatting

changes and other minor edits have been made for clarity by IPQ. Expressions of thanks to the meeting organizers/attendees and disclaimers that the presentation represents the speaker’s views and not …

Balancing Quality Assurance & Innovation In Pharma, Emma Ramnarine

Level 3

At the Pharmaceutical Regulatory Science Team (PRST) workshop on ICH Q9(R1), held at the Technological University Dublin in early June 2023, Boehringer Ingelheim US Biopharma Operations Product Management & Development Operations Head Emma Ramnarine shared her insights on balancing quality assurance and innovation in pharmaceutical manufacturing. She addressed: ● patient-centered transformation ● a watershed moment in her career ● understanding the drug shortage problem ● disruptive collaboration, and ● systems thinking

approaches. Click here for the slides accompanying Ramnarine’s remarks. She connected some of her remarks for the pharmaceutical industry to those made in the previous talk by Ed Hoffman, …

Quality Reborn, Anders Vinther

Level 3

It is time for Quality leaders to not only fulfill the traditional role of ensuring cGMP compliance within the company but also take the Quality profession to the level of business leadership like Deming did in Japan after World War II. FDA has recently stated that they have low confidence in quality management maturity of the pharmaceutical industry.

For quality leaders to also become good business leaders we must educate them in ways that are different from what we currently do. The education should be in the 6 areas

• Visibly Demonstrating Responsibility of Quality
• Risk-Informed Decision Making and Communication
• Engaging …

Preface, Anne Greene, Martin Lipa, Bill Paulson

Level 3

No abstract provided.

Risk-Based Decision-Making – Using Knowledge Of Risk Throughout The Lifecycle, Michael Schousboe

Level 3

This article is based on a presentation given at the event ICH Q9(R1): The Next Frontier hosted by TU Dublin, Grangegorman 01-June-2023

An audience with international thought leaders exploring how the effective use of knowledge can enhance QRM outcomes to benefit the patient

Introducing Research Collaboration And Gmp Human Resource Development At Three Universities With Gmp Laboratories In Japan, Shingou Sakurai, Osamu Hiruta, Ryoko Naruse

Level 3

This paper summarises initiatives presented on June 1^st 2023 at a seminar during a visit to Technological University Dublin. The authors travelled from 3 universities in Japan to share some of the collaborative research, education and training initiatives developed by them,

In their presentation the authors gave an overview of the current situation of Knowledge Management and Quality Culture in Japan, highlighting some recent issues and challenges, and presented some initiatives under development to specifically address these challenges.

Leveraging Advanced Analytics In The Pharmaceutical Industry, Patrick O'Sullivan

Level 3

This article is a transcribed and lightly edited version of Patrick O’Sullivan’s oral presentation to a seminar hosted on 1 June 2023 by the Pharmaceutical Regulatory Science Team (PRST), TU Dublin, titled ICH Q9(R1): The Next Frontier – An audience with international thought leaders exploring how the effective use of knowledge can enhance QRM outcomes to benefit the patient. Patrick presented an overview of how one could leverage advanced analytics in the pharmaceutical Industry.

Regulators Are Exploring With Industry How To Strengthen Quality Risk Management Practices, With Revision Of Ich Q9 A Key Focal Point, ( Ipq )

Level 3

No abstract provided.

Industry/Regulator Dialogue On Knowledge Management Is Intensifying In Wake Of Ich’S Q12 Initiative, ( Ipq )

Level 3

No abstract provided.

Exploring The Role Of Knowledge In The Pharma Workplace Of The Future: An Interactive Workshop Exploring Culture, Km And Opex, Stephanie Friedrichsen, Nuala Calnan (Editor), Martin J. Lipa

Level 3

This article presents a summary of an interactive workshop facilitated by Nuala Calnan and Stephanie Friedrichsen during the conference: ‘ICH Q9(R1): The Next Frontier’ held in Technological University Dublin, Ireland, on 1 June 2023. The summary was prepared by the workshop facilitators in conjunction with Martin Lipa who was a participant at the workshop. The article is written to give a high-level overview of the discussions which took place during the workshop and is not intended to be a complete representation of all the activities, insights and findings.

Links To Prst Past Monographs And Level 3 Special Editions

Level 3

No abstract provided.

Ipq Bibliography Pac Km Qrm 2010 - 2023

Level 3

No abstract provided.

Electromechanical Coupling In Collagen Measured Under Increasing Relative Humidity, Arwa Bazaid, Fengyuan Zhang, Qiancheng Zhang, Sabine Neumayer, Denise Denning, Stefan Habelitz, Ana Marina Ferreira, Brian J. Rodriguez

Articles

The functional role of collagen piezoelectricity has been under debate since the discovery of piezoelectricity in bone in 1957. The possibility that piezoelectricity plays a role in bone remodelling has generated interest in the investigation of this effect in relevant physiological conditions; however, there are conflicting reports as to whether collagen is piezoelectric in a humid environment. In macroscale measurements, the piezoelectricity in hydrated tendon has been shown to be insignificant compared to dehydrated tendon, whereas, at the nanoscale, the piezoelectric effect has been observed in both dry and wet bone using piezo response force microscopy (PFM). In this work, …

The Biological Responses Of Vitamin K2: A Comprehensive Review, Quanxiang Yan, Tao Zhang, Christine O'Connor, James W. Barlow, John Walsh, Gaia Scalabrino, Feng Xu, Helan Sheridan

Articles

Vitamin K1 (VitK1) and Vitamin K2 (VitK2), two important naturally occurring micronutrients in the VitK family, found, respectively, in green leafy plants and algae (VitK1) and animal and fermented foods (VitK2). The present review explores the multiple biological functions of VitK2 from recently published in vitro and in vivo studies, including promotion of osteogenesis, prevention of calcification, relief of menopausal symptoms, enhancement of mitochondrial energy release, hepato-and neuro-protective effects, and possible use in treatment of coronavirus disease. The mechanisms of action associated with these biological effects are also explored. Overall, the findings presented here suggest that VitK, especially VitK2, is …

Design, Synthesis And Biological Evaluation Of A Novel Bioactive Indane Scaffold 2-(Diphenylmethylene)C-2,3-Dihydro-1h-Inden-1-One With Potential Anticancer Activity, Tao Zhang, Vilmar Bandero, Claire Corcoran, Ismael Obaidi, Manuel Ruether, John O'Brien, Lorraine O'Driscoll, Neil Frankish, Helen Sheridan

Articles

Over the past decades, designing of privileged structures has emerged as a useful approach to the discovery and optimisation of novel biologically active molecules, and many have been successfully exploited across and within different target families. Examples include indole, quinolone, isoquinoline, benzofuran and chromone, etc. In the current study, we focus on synthesising a novel hybrid scaffold constituting naturally occurring benzophenone (14) and indanone (22) ring systems, leading to a general structure of 2-(diphenylmethylene)-2,3-dihydro-1H-inden-1-one (23). It was hypothesised this new hybrid system would provide enhanced anti-cancer activity owing to the presence of the common features associated with the tubulin binding …

Investigation Of Oleic Acid As A Dispersant For Hydroxyapatite Powders For Use In Ceramic Filled Photo-Curable Resins For Stereolithography, Brendan Kennedy, Eamonn De Barra, Stuart Hampshire, Maura Kelleher

Articles

Stereolithography allows production of porous hydroxyapatite scaffolds for bone regeneration but is limited by the challenging rheology of ceramic filled resins. Oleic acid, a natural fatty acid, was applied in concentrations of 0.0–0.3 wt% to improve the rheological properties of HAp resins for the fabrication of solid cylinders and scaffolds by digital light processing (DLP) printing in a wiperless system. Bonding by chemisorption was confirmed by FTIR analysis. The powders were then incorporated into a photo-curable resin of 1–6 hexanediol diacrylate at 18–30 vol%. The shear viscosity and sedimentation rates of photocurable resins containing HAp powder decreased with increasing concentration …

Modification Of Hyaluronic Acid To Enable Click Chemistry Photo-Crosslinking Of Hydrogels With Tailorable Degradation Profiles, Ciara Buckley

Articles

Hyaluronic acid (HA) is a naturally occurring mucopolysaccharide that, due to its inherent bioactivity and extracellular matrix-like structure, has the potential to be utilised extensively in tissue engineering. However, this glycosaminoglycan lacks the properties required for cellular adhesion and photo-crosslinking by UV light, which significantly hinders this polymers applicability. This research presents a method for modifying hyaluronic acid via thiolation and methacrylation to generate a novel photo-crosslinkable polymer with improved physicochemical properties, biocompatibility and the potential to customize biodegradability according to the ratio of monomers used. A decrease in stiffness proportional to increasing thiol concentration was observed when testing the …

Enzymatic Electrochemical Biosensors For Neurotransmitters Detection: Recent Achievements And Trends, Zina Fredj, Baljit Singh Dr., Mohamed Bahri, Peiwu Qin, Mohamad Sawan

Articles

Neurotransmitters (NTs) play a crucial role in regulating the behavioral and physiological functions of the nervous system. Imbalances in the concentrations of NT have been directly linked to various neurological diseases (e.g., Parkinson’s, Huntington’s, and Alzheimer’s disease), in addition to multiple psychotic disorders such as schizophrenia, depression, dementia, and other neurodegenerative disorders. Hence, the rapid and real-time monitoring of the NTs is of utmost importance in comprehending neurological functions and identifying disorders. Among different sensing techniques, electrochemical biosensors have garnered significant interest due to their ability to deliver fast results, compatibility for miniaturization and portability, high sensitivity, and good controllability. …

Color-Changing Reflection Hologram For Quality Assurance Of Therapeutic Ultrasound Systems, Tatsiana Mikulchyk, John Walsh, Jacinta Browne, Izabela Naydenova, Dervil Cody

Articles

The acoustic output of clinical therapeutic ultrasound equipment requires regular quality assurance (QA) testing to ensure the safety and efficacy of the treatment and that any potentially harmful deviations from the expected output power density are detected as soon as possible. A hologram, consisting of a reflection grating fabricated in an acrylate photopolymer film, has been developed to produce an immediate, visible, and permanent change in the color of the reconstructed hologram from red to green in response to incident ultrasound energy. The influence of the therapeutic ultrasound insonation parameters (exposure time, ultrasound power density, and proximity to the point …

Effects Of Flexibility In Coarse-Grained Models For Bovine Serum Albumin And Immunoglobulin G, Frank Hirschmann, Hender Lopez, Felix Roosen-Runge, Tilo Seydel, Frank Schreiber, Martin Oettel

Articles

We construct a coarse-grained, structure-based, low-resolution, 6-bead flexible model of bovine serum albumin (BSA, PDB: 4F5S), which is a popular example of a globular protein in biophysical research. The model is obtained via direct Boltzmann inversion using all-atom simulations of a single molecule, and its particular form is selected from a large pool of 6-bead coarse-grained models using two suitable metrics that quantify the agreement in the distribution of collective coordinates between all-atom and coarse-grained Brownian dynamics simulations of solutions in the dilute limit. For immunoglobulin G (IgG), a similar structure-based 12-bead model has been introduced in the literature [Chaudhri …

Structural, Thermal, Optical, And Mechanical Properties Of Composite Films Developed From The Button Mushroom (Agaricus Bisporus)-Sourced High Molecular Weight Chitosan And Potato Starch, Bullyamini Alimi, Monjural Hoque, Shivani Pathania, Jude Wilson, Brendan Duffy, Jesus Maria Frias

Articles

Films were fabricated using the button mushroom (Agaricus bisporus) sourced high molecular weight chitosan with or without potato starch using the casting method. Glycerol was used as the plasticizer. Chitosan content in the film-forming solution (FFS) was varied (0.5, 0.75 and 1.0% w/v of FFS) while potato starch (1.0% of FFS) and glycerol (25% of the total solid content in the solution) contents were not varied. The control sample contained only chitosan (1.0% of the FFS) and glycerol. The effect of increasing the content of chitosan on the rheological properties of FFS and the properties of the films were investigated. …

Isolation And Identification Of Chlorate-Reducing Hafnia Sp. From Milk, William P. Mccarthy, Meghana Srinivas, Martin Danaher, Christine O'Connor, Tom F. O'Callaghan, Douwe Van Sinderen, John Kenny, John T. Tobin

Articles

Chlorate has become a concern in the food and beverage sector, related to chlorine sanitizers in industrial food production and water treatment. It is of particular concern to regulatory bodies due to the negative health effects of chlorate exposure. This study investigated the fate of chlorate in raw milk and isolated bacterial strains of interest responsible for chlorate breakdown. Unpasteurized milk was demonstrated to have a chlorate-reducing capacity, breaking down enriched chlorate to undetectable levels in 11 days. Further enrichment and isolation using conditions specific to chlorate-reducing bacteria successfully isolated three distinct strains of Hafnia paralvei . Chlorate-reducing bacteria were …

A Simple Microcalorimetry System To Determine The Adsorption Behaviour Of Acids In Large Adhesive Bond Gaps Using Base-Initiated Solution Polymerisation Of Ethyl-2-Cyanoacrylate, Kevin Raheem, John Cassidy, Tony Betts, Bernard Ryan

Articles

This work presents the use of a simple microcalorimetry cyanoacrylate (CA) polymerisation system for investigating aspects of CA adhesive cure through gap and adsorption of adhesive acid stabiliser by a range of metal and glass substrates. It is well established that strong acid induced inhibition periods (IPs) are almost directly proportional to the acid concentration in weak base initiated polymerisations of alkyl CAs in tetrahydrofuran (THF). Ethyl cyanoacrylate (ECA) polymerisation IP measurements were used to determine the adsorption of methanesulfonic acid (MSA) in THF or ECA solutions by a range of metal, glass and polypropylene (PP) lap shears surfaces. The …

Use Of Inner/Outer Sphere Terminology In Electrochemistry—A Hexacyanoferrate Ii/Iii Case Study, John Cassidy, Rafaela Cristina De Carvalho, Tony Betts

Articles

Salts of hexacyanoferrate II/III anions have been widely used as redox couple probe molecules to determine the characteristics of electrode surfaces. Examples include the assessment of electrocatalysts for energy applications and electrocatalysts for the detection of biological or chemical species, as well as the determination of electrochemically active surface areas. An examination of the electrochemical literature, based largely on cyclic voltammetric investigations, reveals a wide range of peak separation and/or heterogeneous electron transfer rate constants, classified sometimes as inner or outer sphere electron transfer processes. Originally developed for the mechanistic interpretation of inorganic transition metal compounds in solution, this terminology …

Switch-On Luminescent Sensing Of Unlabelled Bacterial Lectin By Terbium(Iii) Glycoconjugate Systems, Karolina Wojtczak, Eva Zahorska, Ian J. Murphy, Finnja Koppel, Gordon Cooke, Alexander Titz, Joseph P. Byrne

Articles

Interactions of lectins with glycoconjugate-terbium(III) self-assembly complexes lead to sensing through enhanced lanthanide luminescence. This glycan-directed sensing paradigm detects an unlabelled lectin (LecA) associated with pathogen P. aeruginosa in solution, without any bactericidal activity. Further development of these probes could have potential as a diagnostic tool.