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Removing Subjectivity from the Assessment of Critical Process Parameters and Their ImpactA new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster, more consistent, and less subjective critical process parameter quantification, visualization, and documentation.
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Removing Subjectivity from the Assessment of Critical Process Parameters and Their ImpactA new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster, more consistent, and less subjective critical process parameter quantification, visualization, and documentation.
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SCHOTT on the way to ‘zero defect’ glass tubingSCHOTT is integrating a specially developed big data solution into its pharmaceutical tubing production, replacing statistical sample-based quality assurance with 100 percent on-line measurement.
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Chemspec Europe 2019Chemspec Europe will take place from 26 – 27 June 2019 at Messe Basel in Switzerland.
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New Research Reveals a Promising Functional Alternative to Surfactants within Biologic Formulations-Research suggests cyclodextrins could replace surfactants for biologics. -Studies on HPßCD indicate it to be a potential alternative to polysorbates.
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Umicore Precious Metals ChemistryUmicore Precious Metals Chemistry offers a collaborative approach to research, development and commercial manufacturing of your complex organometallic chemistry and catalysis needs.
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Grifols International, S.A.Grifols Partnership is a business-to-business contract development and manufacturing platform for sterile solutions and lipid emulsions with a long-term experience in producing intravenous solutions for the pharmaceutical industry worldwide.
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Near Infrared Spectroscopy as a Versatile PAT Tool for Continuous Downstream BioprocessingThe need for real-time monitoring and control has spurred the development of new analytical tools.
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Material Traceability in Continuous Pharmaceutical Tablet ManufacturingA systematic framework and software are needed to implement material traceability in continuous pharmaceutical tablet manufacturing.
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ITW REAGENTSLatest:
The Decontamination ChallengeThe increase in aseptic processing driven by the growing number of biologically-derived products has led to an increase in freeze-drying applications in this area at both research and production scales.
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Establishing Correlation Between Aerosol and Surface Microbial PopulationsThe following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
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Establishing Correlation Between Aerosol and Surface Microbial PopulationsThe following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
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Establishing Correlation Between Aerosol and Surface Microbial PopulationsThe following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
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Establishing Correlation Between Aerosol and Surface Microbial PopulationsThe following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
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Establishing Correlation Between Aerosol and Surface Microbial PopulationsThe following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
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New Standards Define Single-Use Materials QualificationProposed guidance documents assist drug manufacturers in qualifying single-use systems for commercial drug production.
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The Power of Synchrotron X-Ray Powder Diffraction for the Characterization of PharmaceuticalsX-ray powder diffraction exploits the interaction between x-rays and matter to study the structural and microstructural properties of materials.
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Viewpoint: 2018 a Critical Year for Maturation of European Bio Supply ChainAs Europe's growing biomanufacturing and bioprocessing industries develop, now a crucial time for the small-molecule and biopharma industries to integrate in order to facilitate growth.
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Determination of Related Substances in Pemetrexed Disodium (Form-IV) in Bulk Drug Samples by HPLCThe authors describe the development of a stability-indicating reverse-phase high-performance liquid chromatographic (RP?HPLC) method for the quantitative determination of potential genotoxic impurities present in pemetrexed disodium (form-IV). The chromatographic separation was achieved on a RP?HPLC column (Zorbax SB-Phenyl, Agilent) at ambient temperature with gradient elution using mobile phase A (trifluoroacetic acid [TFA] in water) and mobile phase B (TFA in acetonitrile).
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Case Study: Fast-Track Technology Transfer of a Soft-Gelatin CapsuleIndustry lessons from a fast-track technology transfer of a soft-gelatin capsule (softgel) are multifold. This case study reviews the success factors for effective execution of the technology transfer, which include: strong relationship between the customer, the contract development and manufacturing organization, and other partners based on deep knowledge in the technology; established and proven quality-by-design processes; risk mitigation management; project leadership; flawless execution; and mutual trust.
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Challenges with Successful Commercialization of BiosimilarsThis article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
