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

21:03 EDT 20th June 2018 | BioPortfolio

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

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...

Process and scaling parameters for wet media milling in early phase drug development: A knowledge based approach.

Wet media milling is a well-established unit operation for the manufacturing of suspension formulations during early phase pharmaceutical development. However, knowledge about the kinetics of particle breakage is limited, although the impact of hydro-mechanical process parameters on the mean particle size of finished suspensions has been thoroughly investigated. We performed in this work milling trials with two different compounds on two milling devices with different mechanical design and volume scale. We ...

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...

Measuring Frailty in Medicare Data: Development and Validation of a Claims-Based Frailty Index.

Frailty is a key determinant of health status and outcomes of health care interventions in older adults that is not readily measured in Medicare data. This study aimed to develop and validate a claims-based frailty index (CFI).

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...

Documentation: Records and Reports.

This article deals with documentation to include the beginning of documentation, the requirements of Good Manufacturing Practice reports and records, and the steps that can be taken to minimize Good Manufacturing Practice documentation problems. It is important to remember that documentation for 503a compounding involves the Formulation Record, Compounding Record, Standard Operating Procedures, Safety Data Sheets, etc. For 503b outsourcing facilities, compliance with Current Good Manufacturing Practices is ...

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...

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 ...

Measuring Instrument for Ethical Sensitivity in the Therapeutic Sciences.

There are currently no instruments available to measure ethical sensitivity in the therapeutic sciences. This study therefore aimed to develop and implement a measure of ethical sensitivity that would be applicable to four therapeutic professions, namely audiology, occupational therapy, physiotherapy, and speech-language pathology. The study followed a two-phase, sequential exploratory mixed-methods design. Phase One, the qualitative development phase, employed six stages and focused on developing an instru...

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...

The yeast stands alone: the future of protein biologic production.

Yeasts are promising alternative hosts for the manufacturing of recombinant protein therapeutics because they simply and efficiently meet needs for both platform and small-market drugs. Fast accumulation of biomass and low-cost media reduce the cost-of-goods when using yeast, which in turn can enable agile, small-volume manufacturing facilities. Small, tractable yeast genomes are amenable to rapid process development, facilitating strain and product quality by design. Specifically, Pichia pastoris is becomi...

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...

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...

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.

Derivation of aquatic predicted no-effect concentration (PNEC) for ibuprofen and sulfamethoxazole based on various toxicity endpoints and the associated risks.

For pharmaceuticals, the ecological risk assessment based on traditional endpoints of toxicity could not be properly protective in the long run since the mode of action could vary because they are intended for different therapeutic uses. In this study, the predicted no-effect concentrations (PNECs) of two selected pharmaceuticals, ibuprofen (IBU) and sulfamethoxazole (SMX), were derived based on either traditional endpoints of survival and growth data or some nonlethal endpoints such as reproduction, bioche...

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...

Decentralised manufacturing of cell and gene therapy products: Learning from other healthcare sectors.

Decentralised or 'redistributed' manufacturing represents an attractive choice for production of some cell and gene therapies (CGTs), in particular personalised therapies. Decentralised manufacturing splits production into various locations or regions and in doing so, imposes organisational changes on the structure of a company. This confers a significant advantage by democratising supply, creating jobs without geographical restriction to the central hub and allowing a more flexible response to external pre...


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