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Latest:
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.
Latest:
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.
Latest:
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.
Latest:
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.
