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07:45 EDT 21st March 2019 | BioPortfolio

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Showing "Abzena Selects Sartorius Stedim Biotech Equip Development Manufacturing" PubMed Articles 1–25 of 19,000+

Ensuring Product Quality, Consistency and Patient Supply over Time for a Large-Volume Biologic: Experience with Remicade.

Biologics are produced from living organisms in complex, multi-stage manufacturing processes and contain inherent variability, which must be understood and controlled during manufacturing to avoid unexpected changes in key quality attributes that may contribute to clinically meaningful differences. The process must also meet large commercial demand, while simultaneously being able to accommodate change without sacrificing product consistency. The four key components of successful biologics manufacturing are...

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...

Evaluation of U.S. Manufacturing Subsectors at Risk of Physical Water Shortages.

The potential impact of water shortages on U.S. manufacturing is unknown. While water for manufacturing constitutes an estimated 6% of U.S. water intake, the data (i.e. location, quantity, and purpose of water intake) needed to determine this impact does not exist. This paper will identify manufacturing subsectors at risk of physical water shortages by applying a method for estimating U.S. manufacturing water intake at the necessary spatial and sectoral resolutions. First, the data requirements to quantify ...

Characterizing Drug Product Continuous Manufacturing Residence Time Distributions of Major/Minor Excipient Step Changes using Near Infrared Spectroscopy and Process Parameters.

The material residence time distribution in a continuous manufacturing process can be utilized to develop, design and justify the process control strategy. This paper successfully demonstrates using both major and minor formulation component step changes to determine the system response using either Near Infrared Spectroscopy or process parameters. These options provide development flexibility to determine the system's material residence time earlier in the development process and more cost effectively.

Third-quarter biotech job picture.

Emerging Technologies for Low-Cost, Rapid Vaccine Manufacture.

To stop the spread of future epidemics and meet infant vaccination demands in low- and middle-income countries, flexible, rapid and low-cost vaccine development and manufacturing technologies are required. Vaccine development platform technologies that can produce a wide range of vaccines are emerging, including: a) humanized, high-yield yeast recombinant protein vaccines; b) insect cell-baculovirus ADDomer vaccines; c) Generalized Modules for Membrane Antigens (GMMA) vaccines; d) RNA vaccines. Herein, exis...

New Nonprofit Biotech From Bill and Melinda Gates.

Detection of Transgenic Proteins by Immunoassays.

Rapid development and global cultivation of genetically modified (GM) crops necessitated the use of analytical tools that detect GM crops throughout the product life cycle. Antibody-based immunoassays such as enzyme-linked immunosorbent assays (ELISA) are instrumental in detecting protein expression in transgenic plants. These analytical tools are used throughout development, regulatory registration, commercialization, and stewardship of biotech products. Here we describe the Cry1F ELISA analytical method p...

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...

Biotech leaders call for free press.

US law threatens flow of foreign capital to biotech sector.

Genetic data sharing: a new type of capital.

Over the last three decades, various biotech companies, mostly in North America, have become experts in the production, processing and analysis of large volumes of genetic data. They have surpassed the performance of traditional academic platforms, by appropriating a new economic model: the two-sided market. Thus, by applying web 2.0 ideas, these biotech companies have made it possible for millions of users to produce and "share" data including genetic data, with each other and with third parties through a...

Chemical and physical instabilities in manufacturing and storage of therapeutic proteins.

Development of a robust biologic drug product is accomplished by extensive formulation and process development screening studies; however, even in the most optimal formulation, a protein can undergo spontaneous degradation during manufacture, storage, and clinical use. Chemical changes to amino acid residues, such as oxidation of methionine or tryptophan, or changes in charge such as deamidation or carbonylation, can induce conformational changes in the overall protein structure, potentially leading to chan...

Realizing low-carbon development in a developing and industrializing region: Impacts of industrial structure change on CO emissions in southwest China.

China is undergoing rapid industrial structure change, resulting in great disparities in industrialization stages and CO emission patterns across regions. In this study, we focused on the southwest economic zone (including Chongqing, Sichuan, Guangxi, Yunnan, and Guizhou), which is in the middle-industrialization stage and aims to mitigate CO emissions during strategic industrial transformation. We applied a framework with refined indicators based on input-output analysis (IOA) and structural decomposition ...

A review on chemical composition, mechanical properties, and manufacturing work flow of additively manufactured current polymers for interim dental restorations.

Additive manufacturing (AM) technologies can be used to fabricate 3D-printed interim dental restorations. The aim of this review is to report the manufacturing workflow, its chemical composition, and the mechanical properties that may support their clinical application.

Quality by Design Driven Process Development of Cell Culture in Bioreactor for the Production of Foot-and-Mouth Veterinary Vaccine.

Quality by design (QbD) principle has been established as a guideline to emphasize the understanding of the relationship of product quality with process control. Vaccine product have characteristics of security and high efficiency, but it also has features like complexity and rigorous regulatory for production. This case study describes an example of QbD driven process development for manufacturing a veterinary vaccine produced with baby hamster kidney-21 (BHK-21) cells. The study revealed that cell culture...

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...

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...

Protein G selects two binding sites for carbon nanotube with dissimilar behavior; a molecular dynamics study.

Study of nanostructure-protein interaction for development of various types of nano-devices is very essential. Among carbon nanostructures, carbon nanotube (CNT) provides a suitable platform for functionalization by proteins. Previous studies have confirmed that the CNT induces changes in the protein structure.

Apremilast for the Treatment of Mild-to-Moderate Hidradenitis Suppurativa in a Prospective, Open-Label, Phase 2 Study

Background: Treatment options are limited for patients with hidradenitis suppurativa (HS). Apremilast, an oral phosphodiesterase 4 inhibitor, may offer an attractive therapeutic option for patients with mild-to-moderate HS. Methods: This open-label, phase 2 clinical trial enrolled adults (≥18 years of age) with mild-to-moderate HS. Patients received apremilast 30mg twice daily for 24 weeks after a 5-day titration period. Therapy was discontinued at week 24; data were collected up to week 28. Hidradenitis...

GMP-compatible manufacturing of three iPS cell lines from human peripheral blood.

The utilization of human induced pluripotent stem cells (hiPSCs) for disease modeling and drug discovery is already reality, and several first-in-man-applications as cellular therapeutics have been initiated. Implementation of good manufacturing practice (GMP)-compliant protocols for the generation of hiPSC lines is crucial to increase the application safety as well as to fulfil the legal requirements for clinical trials approval. Here we describe the development of a GMP-compatible protocol for the reprogr...

Bioinspired design and additive manufacturing of soft materials, machines, robots, and haptic interfaces.

Soft materials possess several distinctive characteristics like controllable deformation, infinite degrees of freedom, and self-assembly that make them promising candidates for building soft machines, robots, and haptic interfaces. In this article, we review recent advances in intrinsically soft materials, and soft-material-enabled robots, machines, and haptic interfaces, with emphasis on two specific topics-bioinspired design and additive manufacturing. Biology is an abundant source of inspiration that man...

Comparison between manufacturing sites shows differential adhesion, activation, and GPIbα expression of cryopreserved platelets.

Transfusion of cryopreserved platelets (cryoplatelets) is not common but may replace standard liquid-preserved platelets (PLTs) in specific circumstances. To better understand cryoplatelet function, frozen concentrates from different manufacturing sites were compared.

Partnership for productive development of biosimilar products: perspectives of access to biological products in the Brazilian market.

The manufacturing process for biological products is complex, expensive and critical to the final product, with an impact on their efficacy and safety. They have been increasingly used to treat several diseases, and account for approximately 50% of the yearly budget for the Brazilian public health system. As the patents of biological products expire, several biosimilars are developed. However, there are concerns regarding their efficacy and safety; therefore, the regulatory agencies establish rules to appro...

Simplified end-to-end continuous manufacturing by feeding API suspensions in twin-screw wet granulation.

This study focussed on investigating the coupling of continuous manufacturing of drug substance and continuous manufacture of drug product. An important step in such an integrated end-to-end continuous manufacturing was envisioned by dosing the API as suspension into a twin-screw wet granulation process. To achieve this goal, a model drug substance (ibuprofen) was fed as a concentrated aqueous suspension (50% w/w) into a twin-screw granulator and compared against traditional solid feeding of the model drug ...

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