PubMed Journals Articles About "Quotient Sciences Acquires Pharmaterials Based Contract Development Manufacturing" RSS

17:47 EDT 14th August 2018 | BioPortfolio

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Showing "Quotient Sciences Acquires Pharmaterials based Contract Development Manufacturing" PubMed Articles 1–25 of 48,000+

A tutorial for developing a topical cream formulation based on the Quality by Design approach.

The pharmaceutical industry has entered in a new era, as there is a growing interest in increasing the quality standards of dosage forms, through the implementation of more structured development and manufacturing approaches. For many decades, the manufacturing of drug products was controlled by a regulatory framework to guarantee the quality of the final product through a fixed process and exhaustive testing. Limitations related to the Quality by Test (QbT) system have been widely acknowledged. The emergen...

Prioritizing Type of Industry through Health Risk Assessment of Occupational Exposure to Dimethylformamide in the Workplace.

The purpose of this study was to classify hazards at an industrial level and evaluate the exposure risks of workers exposed to dimethylformamide (DMF) used as a solvent in the workplace and to determine industries that need priority measures in managing DMF exposure. We calculated hazard quotients at an industrial level. The exposure data of DMF in the workplace were obtained from the work environment monitoring program provided by the Korea Occupational Safety and Health Agency. The evaluation was conducte...

Transforming nanomedicine manufacturing toward Quality by Design and microfluidics.

Nanopharmaceuticals aim at translating the unique features of nano-scale materials into therapeutic products and consequently their development relies critically on the progression in manufacturing technology to allow scalable processes complying with process economy and quality assurance. The relatively high failure rate in translational nanopharmaceutical research and development, with respect to new products on the market, is at least partly due to immature bottom-up manufacturing development and resulti...

Sticking and picking in pharmaceutical tablet compression: An IQ Consortium Review.

Sticking and picking during tablet manufacture has received increasing interest recently, as it causes tablet defects, downtime in manufacturing and yield losses. The capricious nature of the problem means that it can appear at any stage of the development cycle, even when it has been deemed as low risk by models, tests and previous experience. In many cases, the problem manifests when transferring the process from one manufacturing site to another. Site transfers are more common than in previous times due ...

Empathizing-systemizing cognitive styles: Effects of sex and academic degree.

This study tests if the drives to empathize (E) and systemize (S), measured by the Systemizing Quotient-Revised (SQ-R) and Empathy Quotient (EQ), show effects of sex and academic degree. The responses of 419 students from the Humanities and the Physical Sciences were analyzed in terms of the E-S theory predictions. Results confirm that there is an interaction between sex, degree and the drive to empathize relative to systemize. Female students in the Humanities on average had a stronger drive to empathize t...

Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing.

The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the focus of this...

NEV supply chain coordination and sustainability considering sales effort and risk aversion under the CVaR criterion.

In a two-echelon new energy vehicle (NEV) supply chain consisting of a risk-neutral manufacturer and a risk-averse retailer, the coordination and sustainability problem is investigated. The risk-averse retailer, who makes sales effort and undertakes the incurred effort cost, decides the order quantity and sales effort level under the Conditional Value-at-Risk (CVaR) criterion. We derive the optimal centralized decisions of a vertically integrated supply chain where the retailer is owned by the manufacturer....

Squeakr: an exact and approximate k-mer counting system.

k-mer-based algorithms have become increasingly popular in the processing of high-throughput sequencing data. These algorithms span the gamut of the analysis pipeline from k-mer counting (e.g. for estimating assembly parameters), to error correction, genome and transcriptome assembly, and even transcript quantification. Yet, these tasks often use very different k-mer representations and data structures. In this article, we show how to build a k-mer-counting and multiset-representation system using the count...

Antimicrobial resistance and the environment: Assessment of advances, gaps and recommendations for agriculture, aquaculture and pharmaceutical manufacturing.

A roundtable discussion held at the 4th international symposium on the Environmental Dimension of Antibiotic Resistance (EDAR4) considered key issues concerning the impact on the environment of antibiotic use in agriculture and aquaculture, and emissions from antibiotic manufacturing. The critical control points for reducing emissions of antibiotics from agriculture are antibiotic stewardship, and the pre-treatment of manure and sludge to abate antibiotic resistant bacteria. Antibiotics are sometimes added ...

RTD-based Material Tracking in a Fully-Continuous Dry Granulation Tableting Line.

Continuous manufacturing (CM) offers quality and cost-effectiveness benefits over currently dominating batch processing. One challenge that needs to be addressed when implementing CM is traceability of materials through the process, which is needed for the batch/lot definition and control strategy. In this work the residence time distributions (RTD) of single unit operations (blender, roller compactor and tablet press) of a continuous dry granulation tableting line were captured with NIR based methods at se...

Continuous manufacturing and analytical characterization of fixed-dose, multilayer orodispersible films.

Various drug therapies require more than one active pharmaceutical ingredient (API) for an effective treatment. There are many advantages, e.g. to improve the compliance or pharmacodynamic response in comparison to a monotherapy or to increase the therapy safety. Until now, there are only a few products available for the paediatric population due to the lack of age appropriate dosage forms or studies proving the efficacy and safety of these products. This study aims to develop orodispersible films (ODFs) in...

The poverty of theory: Evidence-based medicine and the social contract.

A guide to manufacturing CAR T cell therapies.

In recent years, chimeric antigen receptor (CAR) modified T cells have been used as a treatment for haematological malignancies in several phase I and II trials and with Kymriah of Novartis and Yescarta of KITE Pharma, the first CAR T cell therapy products have been approved. Promising clinical outcomes have yet been tempered by the fact that many therapies may be prohibitively expensive to manufacture. The process is not yet defined, far from being standardised and often requires extensive manual handling ...

Perfusion mammalian cell culture for recombinant protein manufacturing - A critical review.

The manufacturing of recombinant protein is traditionally divided in two main steps: upstream (cell culture and synthesis of the target protein) and downstream (purification and formulation of the protein into a drug substance or drug product). Today, cost pressure, market uncertainty and market growth, challenge the existing manufacturing technologies. Leaders in the field are active in designing the process of the future and continuous manufacturing is recurrently mentioned as a potential solution to addr...

Structure-Function Relationships for Recombinant Erythropoietins: A Case Study From a Proposed Manufacturing Change With Implications for Erythropoietin Biosimilar Study Designs.

Comparability studies used to assess a proposed manufacturing change for a biological product include sensitive analytical studies to confirm there are no significant differences in structural or functional attributes that may contribute to clinically meaningful changes in efficacy or safety. When a proposed change is relatively complex or when clinically relevant differences between the product before and after the change cannot be ruled out based on analytical studies, nonclinical and clinical bridging st...

What is the impact of physical activity and physical function on the development of Multimorbidity in older adults over time? A population based cohort study.

Multimorbidity is recognised internationally as having a serious impact on health outcomes. It is associated with reduced quality of life, increased healthcare utilisation and future functional decline. Physical activity is associated with good health and psychological well-being. The aim of this study was to identify the impact of physical activity and physical function on the development and worsening of multimorbidity over time.

"You Can See How Things Will End by the Way They Begin": The Contribution of Early Mutual Obligations for the Development of the Psychological Contract.

This study explores dynamic processes in the development of the psychological contract, focusing on the interaction of obligations related to the two parties (i.e., employees' perceptions of both their own and the organization's obligations fulfillment) on attitudinal outcomes (organizational commitment and turnover intention) during the initial stage of the employment relationship. In a twofold cross-sectional and two-wave study on newly hired correctional police officers, we examined: (a) whether percepti...

A Combined Computer-Aided Approach to Drive the Identification of Potential Epitopes in Protein Therapeutics.

The identification of fragment sequences, or motifs, within a therapeutic protein that may elicit an immune response when processed by T-cells can be provided by computer-aided approaches. Immunogenicity is a significant problem associated with protein therapeutics and should be investigated in the early stage of protein-based drug development to avoid treatment resistance and potentially life-threatening immune responses.

Actin Disassembly: How to Contract without Motors?

Contractile actin networks take on various functions in cells. How disordered actin networks contract is still poorly understood. A recent study proposes a contractile mechanism that is driven by actin disassembly and required to prevent chromosome losses in starfish oocytes.

Distress and worry as mediators in the relationship between psychosocial risks and upper body musculoskeletal complaints in highly automated manufacturing.

As a result of changes in manufacturing including an upward trend in automation and the advent of the fourth industrial revolution, the requirement for supervisory monitoring and consequently, cognitive demand has increased in automated manufacturing. The incidence of musculoskeletal disorders has also increased in the manufacturing sector. A model was developed based on survey data to test if distress and worry mediate the relationship between psychosocial factors (job control, cognitive demand, social iso...

Retailer Stackelberg game in a supply chain with pricing and service decisions and simple price discount contract.

This paper studies the Retailer Stackelberg game in a supply chain consisting of two manufacturers and one retailer where they compete simultaneously under three factors including price, service and simple price discount contract. It is assumed that the second manufacturer provides service directly to his customers, and the retailer provides service for the first product's customers, while the retailer buys the first product under price discount from the first manufacturer. The analysis of the optimal equil...

Perovskite Solar Cells: Toward Industrial-Scale Methods.

Research progress in hybrid perovskite solar cells has increased enormously over the last years, making perovskites very promising candidates for future PV technologies. Perovskite solar cells use abundant and low-cost starting materials, providing economic advantages for large-scale implementation. A transition from laboratory-scale fabrication to industrial manufacturing requires scaling up of the dimension of the devices; manufacturing of large-area modules, considering the development of interconnection...

The Development of Wisdom: A Social Ecological Approach.

This study examined the development of wisdom within the context of difficult life events (DLEs), and the importance of individuals and their social environments in this process of growth. Social support has long been studied in adulthood, yet less is known about the ways social transactions can promote wisdom.

Inhibition of BMP4 and Alpha Smooth Muscle Actin Expression in LX-2 Hepatic Stellate Cells by BMP4-siRNA Lipid Based Nanoparticle.

To develop and characterize vitamin A (VA)-coupled liposomes for the targeted delivery of BMP4-siRNA to hepatic stellate cells (HSC). VA was selected to increase the uptake by HSC based on their function in the storage of VA.

When Gist and Familiarity Collide: Evidence From False Recognition in Younger and Older Adults.

Aging is associated with decreased recollection required to offset misleading effects of familiarity, as well as an increased mnemonic reliance on gist-based over detail-based information. We tested the novel hypothesis that age-related decrements in overriding familiarity can be eliminated under conditions in which gist-based information facilitates retrieval.

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