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Tools for Enabling Process Analytical Technology Applications in BiotechnologyIn this paper, the authors review the various analytical methods that can enable use of PAT.
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Moisture Matters in Lyophilized Drug ProductUsing an alternate moisture-generation method may provide more accurate data for regulatory submissions.
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Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
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Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
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Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
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Filling of Asthma Inhalers with Liquid Nitrogen: Cryogenic Product Cooling of Aerosol PropellantsThis case study describes how a major pharmaceutical manufacturer was equipped with four filling lines, for metered dose inhalers, supplied with a nitrogen cooling system to prevent spontaneous vaporization of the propellant gas. By doing so, a cost-effective and environmentally friendly solution was provided to a hazardous situation, which also complied with regulatory directives.
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Collaborative Work can Lead to InnovationIn drug development, the majority of new chemical entities are lipophilic and/or poorly soluble. New actives often fail during development due to these challenging properties.
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Energy Conservation in Pharmaceutical ManufacturingThe authors discuss opportunities for energy efficiency in pharmaceutical manufacturing.
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IMS Limit Test Improves Cleaning Verification and Method DevelopmentA limit test using ion mobility spectrometry (IMS) has the potential to dramatically reduce the time required for cleaning verification and cleaning method development. The traditional approach to cleaning verification, often using HPLC, is relatively resource intensive and can lead to significant delays in reporting results. The main advantage of IMS is that results are seen virtually instantaneously, so any necessary re-measurement can be done very quickly. If the results demonstrate cleanliness, production can resume in a matter of hours not days.
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Evaluating Impurities in Drugs (Part II of III)In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities.
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Evaluating Impurities in Drugs (Part II of III)In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities.
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The Digital Supply Chain: Seizing Pharma’s Untapped OpportunityCurrently, pharmaceutical manufacturers are said to waste $25 billion on supply chain inefficiencies. Technology offers a way to achieve transparency and results.
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GMP/GDP Inspections: Challenges and Opportunities Revealed by the COVID-19 PandemicAn annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.
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GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and CommercializationA two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
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GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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Head in the CloudsWe interview Subhro Mallik from IT firm Infosys about how pharma is responding to the cloud computing phenomenon and what more can be done to realise business benefits.
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Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and CommercializationA two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
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Keys to Managing Growth of Your Quality OrganizationOptimal marketing potential begins with designing a strong quality organization and managing the rapid growth within QA/QC groups.
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GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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Single-Use Systems: Enabling the Future of Biologics ManufacturingSingle-use technologies, which started off as a tool for small-volume solution storage and transport has now become the central, enabling technology around which manufacturing processes and facilities are being designed.
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Ethyl Cellulose as a Matrix Former: The Influence of Particle Size on Tabletting and Drug Release BehaviourThe aim of this work was to investigate the compactibility, compressibility and drug release behaviour of different fractions of a commercially available ethyl cellulose.
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Part VII GMPs for Small Molecule Drugs in Early Development Workshop SummaryThe authors explore and define common industry approaches and practices when applying GMPs in early development.
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Key parameters to be optimized in the development and manufacturing of oral solid-dosage formsAnil Kane, executive director, Global Head of Formulation Sciences, Pharmaceutical Development Services at Patheon discusses key parameters in the development and manufacturing of oral solid-dosage forms.
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Building Robust Specifications Using Powder TestingAdvanced powder testing is a useful tool to differentiate materials and optimize the supply chain.
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GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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Validation Changes to the USP Assay Method for Ibuprofen TabletsThis study investigated the effectiveness of the direct extraction of tablets and shaking time on the disintegration of tablets, solubilization, and recovery of ibuprofen from tablets of various formulations, strengths, and spiked placebo.
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Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
