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Designing a winning process development strategyProcess development is an important aspect of biopharmaceutical development.1,2 Through studies in the pharmaceutical industry, Pisano suggests that companies able to develop and implement new process technologies quickly and effectively have a competitive edge. In addition, the fact that the production cost of biopharmaceuticals could be up to 25% of sales value means that the failure to develop a viable process could result in uneconomic manufacturing routes and the inability to capture fully the value of the firm's discovery.3
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The Influence of Pregelatinized Starch Disintegrants on Interacting Variables that Act on Disintegrant PropertiesThis study evaluates the quantitative effects of the nature and concentrations of disintegrants and a tablet's relative density on disintegrant properties such as disintegration time and the crushing strength-friability/disintegration time ratio.
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Time Is Of The EssenceGiving contamination time to build up can cause headaches for more than just your company.
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Project Management and CMO–Sponsor RelationsUsing basic project management tools and ideas in the transfer process saves time and money and ensures high success rates.
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From Quality by Inspection to Quality by Design: A Roadmap for SuccessCompanies must create a risk-based framework for developing and manufacturing drugs, and acquire the scientific knowledge and technological skills to create more complex products.
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Why It Pays To Be CleanProcess industries are faced with increasing demands for product safety, improved quality, efficiency and profitability. The chemical, pharma and cosmetic industries are no exception.
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Understanding Data, Symbol, and Technology OptionsAlthough the main purpose of the proposed unit-of-use bar coding mandate is to reduce medication errors, manufacturers may find additional benefits to compliance, including reduced materials and finshed-good inventory requirements, improved sample management, and streamlined recalls.
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The role of media fills in process controlThere is currently no vaccination or cure for prion diseases and contamination of a parenteral or infusion pharmaceutical product could prove fatal.
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Designing & Implementing Pharmaceutical Clean RoomsPossible cross-contamination issues should be eliminated at the early stage of the project. The project sponsor should ensure that all relevant personnel from the production, quality control, logistics, and maintenance departments, as well as engineering, are involved in the conceptual stages of a design.
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Clean Rooms and Air Handling Systems — Design for ComplianceThis article provides an overview of the important factors associated with air handling systems within pharmaceutical and biopharmaceutical facilities. It provides information on the need for these systems, design considerations and advice on the approach to commissioning and qualification.
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Analysing Raw Materials and Formulations Using High Resolution Ultrasonic SpectroscopyHR-US is a nondestructive technique with enormous potential for the analysis of materials and formulations used in the pharmaceutical industry.
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Containment Levels and Facility DesignThe influence of containment classification in facility design cannot be underestimated. It can, for example, determine the extent of the design process and the level of equipment needed to safeguard human life and the surrounding environment. This article discusses factors that should be considered when planning such a containment facility, including material flow, process equipment and regulatory guidelines.
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Pharmaceuticals visualize successWith a finger on the pulse of an evolving market, the sales and marketing team can visually demonstrate trends and new market opportunities to the R&D team
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Designing a winning process development strategyProcess development is an important aspect of biopharmaceutical development.1,2 Through studies in the pharmaceutical industry, Pisano suggests that companies able to develop and implement new process technologies quickly and effectively have a competitive edge. In addition, the fact that the production cost of biopharmaceuticals could be up to 25% of sales value means that the failure to develop a viable process could result in uneconomic manufacturing routes and the inability to capture fully the value of the firm's discovery.3
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Barriers and Solutions to Effective External Collaboration in BiopharmaAs biopharma companies rapidly change their focus, they may lack the laboratory space, instrumentation, and the scientific knowledge to support biologics research.
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Process Analytical Technology: Real-Time ReliabilityTo implement process analytical technology systems into the current information technology landscape, manufacturers will need to adopt continuously available systems and infrastructures.
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How polymeric microspheres deliver the goodsDrug delivery systems using biocompatible polymers allow controlled release of therapeutics, addressing many of the challenges of conventional administration. Polymer microspheres are attractive delivery systems, having a wide application in numerous therapeutic indications. This article reviews the current use and trends for polymer microspheres, and compares production methods and polymer characteristics.
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Distinguishing Between Cleanroom Classification and MonitoringA one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.
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Characterization of Polymeric ExcipientsThis article summarizes the evolution of the viscosity standards and their corresponding applications in the USP−NF compendia.
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Integrity Testing of Sterilizing Grade Filters: Comparative Investigation of Pressure Drop and Flow Rate MeasurementsTesting sterilizing grade filters using integrity testers has become a standard method in biopharmaceutical production and quality assurance. In accordance with international regulations and recommendations, these filters should be tested before and after filtration. For these applications, a variety of automatic integrity testers is available. Currently, there are two groups of devices that are used to conduct validated testing procedures, such as the bubble point test, the diffusion test, and the water intrusion test (WIT) and water flow test (WFT). Whereas one group of devices relies on the principle of flow measurement, the other group is based on pressure drop measurements. The following report compares the accuracy of the two test methods, using the WFT as a reference.
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The Effect of Core Design and Formulation on the Quality of Film Coated TabletsThis article examines the importance of core design and formulation on the quality of a film coated tablet...
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Paperless Reporting: How to Satisfy FDAMost, if not all, pharmaceutical companies today are moving towards a paperless reporting structure. This article examines FDA's 21 CFR Part 11 regulations, which relate to technical and procedural compliance for electronic records and signatures.
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Calibration of Lyophilization Pressure GaugesMeasurements of lyophilization pressure are accurate only if the gauges that are used have been properly calibrated.
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Current Trends in BiomanufacturingThe limited effectiveness of some existing drugs and demand for new therapeutic candidated for complex diseases has spurred the development of the biopharmaceutical market...
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Controlled-Release of Oral Dosage FormsThe development of controlled-release formulations continues to be a big success for the pharmaceutical industry. The success of any technology relies on the ease of its manufacturing process and its reproducibility of desirable biopharmaceutical properties.
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Hydrogels for the Controlled Release of Pharmaceutical ProteinsTwo types of hydrogels used in parenteral protein-delivery systems offer opportunities for achieving a variety of prolonged- and delayed-release patterns.
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Targeted Cationic Liposomes: Technologies and DevelopmentsCationic liposomes are widely used in gene therapy as a safe alternative to highly immunogenic viral vectors. Attachment of a tissue-specific ligand to the surface of the liposomes can increase specificity and reduce undesired transfection. Targeted liposomes can be categorized as either immunoliposomes or ligand-targeted liposomes. The author provides a brief review of tumour-specific and liver-targeted cationic liposomes and strategies for the development of liposome?ligand complexes.
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The Future State of Computer Validation, Part II: Increasing the Efficiency of Computer Validation PracticesPart I of this article was published in the March 2003 issue of 21 CFR Part 11: Compliance and Beyond. In this issue, Part II discusses the potential advances and changes that must be made for computer validation to remain innovative and relevant to the industry.
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The Fabrication And Evaluation of the Formulation Variables of a Controlled-Porosity Osmotic Drug Delivery System with Diltiazem HydrochlorideThe study presented in this article used a controlled-porosity osmotic pump, which was prepared in the form of a bilayered tablet containing a drug compartment and an osmogen layer for the delayed release of diltiazem HCI.
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Nanotechnology Applications for Drug DeliveryNanotechnology is believed to hold enormous promise for the future of medicine and healthcare...
