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

04:48 EDT 19th October 2018 | BioPortfolio

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Showing "Quotient Sciences Acquires Pharmaterials based Contract Development Manufacturing" PubMed Articles 1–25 of 49,000+

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...


Service Coordination by Public Sector Managers in a Human Service Contracting Environment.

Despite emerging evidence of contracting for evidence-based practices (EBP), little research has studied how managers lead contract-based human service delivery. A 2015 survey of 193 managers from five San Francisco Bay Area county human service departments examined the relationship between contract-based service coordination (i.e., structuring cross-sector services, coordinating client referrals and eligibility, overseeing EBP implementation) and the predictors of managerial role, involvement, and boundary...

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...

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....

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...

Optimization of pellets manufacturing process using rough set theory.

Pharmaceutical pellets are spherical agglomerates manufactured in extrusion/spheronization process. The composition of the pellets, the amount of active pharmaceutical ingredient (API) and the type of used excipients have an influence on the shape and quality of dosage form. A proper quality of the pellets can also be achieved by identifying the most important technological process parameters. In this paper, a knowledge discovery method, called dominance-based rough set approach (DRSA) has been applied to e...

Dropwise Additive Manufacturing of Pharmaceutical Products using Particle Suspensions.

The principal method of drug delivery is by oral solid doses, the production of which often necessitates multiple post-crystallization unit operations to ensure content uniformity and/or enhance bioavailability. As an alternative to conventional dose production methods, applications of additive manufacturing technologies based on solvent- or melt-based formulations have demonstrated the potential for improvements to process efficiency, flexibility and dosing precision. Here we explore the use of particulate...

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...

In-depth evaluation of data collected during a continuous pharmaceutical manufacturing process: A multivariate statistical process monitoring approach.

The current work presents an in-depth evaluation of continuously collected data during a twin-screw granulation and drying process performed on a continuous manufacturing line. During operation, the continuous line logs 49 univariate process variables, hence generating a large amount of data. Three identical 5-hour continuous manufacturing runs were performed. Multivariate data analysis tools, more specifically latent variable modeling tools such as principal component analysis, were utilized to extract inf...

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

Using Manufacturing Design Space Concepts for Stability Risk Assessment-Gabapentin NIPTE/FDA Case Study.

A quantitative, model-based risk assessment process was evaluated using Bayesian parameter estimation to determine the posterior distribution of the probability of a model tablet formulation's (gabapentin) ability to meet end-of-expiry stability criteria-based manufacturing controls. Experimental data was obtained from an FDA-supported, multi-year project that involved researchers at nine universities working collaboratively with industrial and governmental scientists under the leadership of the National In...

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...

Quantitative Assessment of Environmental Impact of Biologics Manufacturing Using Process Mass Intensity Analysis.

Process mass intensity (PMI) is a benchmarking metric to evaluate the efficiency of a manufacturing process, which is indicative of the environmental impact of the process. Although this metric is commonly applied for small molecule manufacturing processes, it is less commonly applied to biologics. In this study, an Excel based tool developed by the ACS GCI Pharmaceutical Roundtable was used to calculate PMI of different manufacturing processes for a monoclonal antibody (mAb). For the upstream process, thre...

"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...

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.

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.

Risk-based approach for method development in pharmaceutical quality control context: A critical review.

Pharmaceutical regulatory bodies increasingly require the implementation of systematic approaches in pharmaceutical product development. Quality control methods play a key role in the control strategy of drugs manufacturing to assure their quality. A risk-based approach in the analytical method development is strongly recommended to ensure that the method performances fit the purpose of the method during its entire life-cycle. In the last decade, analytical quality by design (AQbD), as risk management orien...

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...

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.

Additive Manufacturing as a Method to Design and Optimize Bioinspired Structures.

Additive manufacturing (AM) is a current technology undergoing rapid development that is utilized in a wide variety of applications. In the field of biological and bioinspired materials, additive manufacturing is being used to generate intricate prototypes to expand our understanding of the fundamental structure-property relationships that govern nature's spectacular mechanical performance. Herein, recent advances in the use of AM for improving the understanding of the structure-property relationship in bio...

The Effects of Weak Static Magnetic Field on the Development of Organotypic Tissue Culture in Rats.

The effects of weak static magnetic field on the organotypic tissue culture of the rat cerebral cortex, liver, and spleen have been investigated. Exposure to a 200 μT static magnetic field induces tissue development, leading to the intensification of regeneration processes compared to the control explants.


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