Authors
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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.
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Case Study: Retrofitting Two New High-Purity Water SystemsThe existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.
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Case Study: Retrofitting Two New High-Purity Water SystemsThe existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.
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Case Study: Retrofitting Two New High-Purity Water SystemsThe existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.
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Robotic Vial Filling and Capping Machine (RVFCM2) under isolatorRobotics and isolators are an increasingly popular combination in the pharmaceutical industry due to the rising number of high-value therapies, such as Cell and Gene Therapies.
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Peter Huber Kältemaschinenbau AG at Achema 2022At ACHEMA 2022, Huber Kältemaschinenbau will be showcasing high-precision temperature control solutions for the process industry. The product presentation will focus on the Unistat process circulators.
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Aseptic Transfer Technology: Weighing Up the Advantages of Varying Approaches for Sterile Drug ManufacturingThe author reviews current approaches to sterile containment and compares several sealed transfer and barrier techniques, including isolators, restricted access barrier systems, and split butterfly valve technology.
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Addressing Segregation of a Low-Dosage Direct BlendThe authors modified equipment and the manufacturing process to re-establish content uniformity among tablets.
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Stability Indicating Methods for Aluminum Adsorbed Vaccine ProductsThe authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.
