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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...

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...

On-line rheological characterization of semi-solid formulations.

The rheological profile of a semi-solid product is a critical quality attribute. To monitor changes of this attribute during manufacturing, it would be beneficial to measure the rheological parameters in an on-line or in-line mode and implement this as a part of a control strategy for manufacturing of semi-solids. None of the process analytical technology (PAT) tools for measuring the rheological parameters have yet been widely accepted in the pharmaceutical area, as most of the equipment can only measure v...

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...

Factors associated with residents' contract behavior with family doctors in community health service centers: A longitudinal survey from China.

China adopted family doctor (FD) to help achieve "Healthy China 2030" through providing continuous, comprehensive, and life-cycle contract services. However, there is a disparity between actual and targeted FD use, as residents continue to visit specialists in large hospitals. The government implemented initiatives to improve residents' willingness to sign up with and visit their FDs. Factors that influence contract behavior are therefore significant for frontier policy research.

Direct compression tablet containing 99% active ingredient - a tale of spherical crystallization.

Direct compression (DC) is the easiest and most cost-effective process for tablet manufacturing, since it only involves blending and compression. However, active pharmaceutical ingredients (API) generally exhibit poor mechanical and micromeritic properties, which necessitate dilution and the use of high percentage of excipients to enable a robust DC manufacturing process. Consequently, drug loading in DC tablets is usually low (typically < 30%, w/w). In this study, spherical crystallization by the quasi-emu...

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...

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...

Decreasing the Toxicity of Radiation Therapy: Radioprotectors and Radiomitigators Being Developed by the National Cancer Institute Through Small Business Innovation Research Contracts.

The use of radioprotectors and radiomitigators could improve the therapeutic index of radiation therapy. With the intention of accelerating translation of radiation-effect modulators (radioprotectors and mitigators), the Radiation Research Program (RRP) and SBIR (Small Business Innovation Research) Development Center within the National Cancer Institute (NCI) issued four Requests for Proposals (RFPs) from 2010 to 2013. Twelve SBIR contract awards in total were made in response to the four RFPs from Septembe...

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...

Gastrointestinal illness among contract construction workers at a chicken processing facility-Minnesota, 2016.

After Campylobacter infection was reported in a contract construction worker (contractor) at a chicken processing facility, we described the illness and determined illness associations with workforce exposure.

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...

Hold-relax and contract-relax stretching for hamstrings flexibility: A systematic review with meta-analysis.

To synthesize evidence on the effects of hold-relax and contract-relax stretching (HR and CR) on hamstrings flexibility compared with no intervention and other stretching techniques.

Computer aided design and three-dimensional printing for apicoectomy guide template.

To establish an apicoectomy guide template design and manufacturing method, based on multi-source data fusion, computer aided design (CAD) and fused deposition modeling (FDM). The feasibility of the guide template was preliminary evaluated by the in vitro model experiment.

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.

A continuous manufacturing concept for a pharmaceutical oral suspension.

The aim of this study was to investigate the applicability of an innovative continuous manufacturing system for semi-solid and liquid pharmaceutical formulations. A commercially available pharmaceutical oral suspension was selected as model formulation. Premixes of the raw materials were dosed via peristaltic pumps to the mixing compartment, which consists of two consecutive mixing units. An experimental design was used to study the influence of several process parameters (throughput, mixing speed in mixing...

Fifty-eight Years and Counting: High-Impact Publishing in Computational Pharmaceutical Sciences and Mechanism-based Modeling.

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