Authors
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Covalidation Strategies to Accelerate Analytical Method Transfer for Breakthrough TherapiesThe primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
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Covalidation Strategies to Accelerate Analytical Method Transfer for Breakthrough TherapiesThe primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
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Spectroscopy Facilitates Lean AnalysisSpectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.
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The Impact of AI on PharmaCPHI’s Annual Report predicts huge impact of AI on drug development and manufacturing.
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GMP Facility Modernization: Opportunities for Successful ImplementationThe DME Facility Focus survey revealed best practices for coping with the challenges of aging facilities and implementing facility modernization.
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Understanding Fluidized-Bed GranulationThis study demonstrates the beneficial use of a spatial-filter velocimetry particle-size analyzer during granulation.
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Combination Products: Regulatory and Patent Issues You Should Consider NowThe authors discuss regulatory and patent issues with combination products.
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Combination Products: Regulatory and Patent Issues You Should Consider NowThe authors discuss regulatory and patent issues with combination products.
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Combination Products: Regulatory and Patent Issues You Should Consider NowThe authors discuss regulatory and patent issues with combination products.
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Combination Products: Regulatory and Patent Issues You Should Consider NowThe authors discuss regulatory and patent issues with combination products.
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Determining Comparability of Biosimilars Through Statistical ApproachesIt is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.
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Establishing Systems Suitability and Validity Criteria for Analytical Methods and BioassaysEnsuring reliable analytical methods and bioassays requires a well-thought-out strategy for evaluating method validity and systems suitability.
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The Challenge of IDMP ComplianceHaving an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.
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Technology to the Rescue for Data Integrity Challenges?Informatics platforms and automation solutions may support efforts to improve data integrity practices.
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An Investigation of the Anomeric Stability of Lactose Powder Stored Under High Stress ConditionsThis study investigated the stability of solid lactose stored under high temperature and humidity conditions.
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An Investigation of the Anomeric Stability of Lactose Powder Stored Under High Stress ConditionsThis study investigated the stability of solid lactose stored under high temperature and humidity conditions.
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An Investigation of the Anomeric Stability of Lactose Powder Stored Under High Stress ConditionsThis study investigated the stability of solid lactose stored under high temperature and humidity conditions.
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An Investigation of the Anomeric Stability of Lactose Powder Stored Under High Stress ConditionsThis study investigated the stability of solid lactose stored under high temperature and humidity conditions.
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Trends in On-Site Supplier AuditsResearch suggests that on-site audits are becoming less meaningful because suppliers are less willing to devote time to them.
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Overcoming the Challenges of Capsule Filling in Preclinical and Clinical StudiesThe authors discuss the challenges of capsule filling in preclinical and clinical studies.
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Evaluating Progress in Analytical Quality by DesignThe authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
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Evaluating Progress in Analytical Quality by DesignThe authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
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Can CMOs Solve China’s Biopharma Staffing Shortages?Contract manufacturing organizations may fill manufacturing gaps created by a lack of trained workers at Chinese biopharma companies.
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Delivering connected devices for tomorrow’s drug delivery challengesFrom pressurized metered dose inhalers to connected breath-actuated inhaler platforms and dry powder inhalers, Aptar Pharma’s c-Device solutions are developed to meet the unique data stream objectives of its customers
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Enabling Fluid Transfer for Cell Therapies: An Industry ChallengeThe transfer of fluids is governed by different equipment requirements across the medical, biopharma, and cell therapy manufacturing industries.
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How to Avoid the Number One Reason for Receiving FDA 483sAn enterprise quality management software system can minimize human error and help pharmaceutical manufacturers maintain standard operating procedures to prevent deviations from GMP resulting from not having or following written procedures.
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Improving Productivity to Drive Drug Discoveries to PatientsBiomedical researcher shares insights from a career dedicated to advancing therapeutic innovations for unmet medical needs.
