Authors
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Patents and Postapproval Batch TestingCan postapproval FDA filings immunize pharma companies from patent lawsuits?
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Method Validation by Design to Support Formulation DevelopmentThe authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.
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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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Challenges and Strategies for the Downstream Purification and Formulation of Fab Antibody FragmentsAntibody fragments pose unique challenges in terms of recovery, purification, and formulation.
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Validation of a Clean-in-Place System on a Capsule Filling MachineThe aim of this study was to validate the automated clean-in-place (CIP) system installed on a capsule filling machine to determine its ability to adequately eliminate contaminants. The results obtained from the proposed cleaning validation trial showed that all the soluble tracer was removed after the washing procedure. At the end of the CIP procedure, the discharged water had the same pH, phosphate content and total organic content as the supplied water. Lack of cross-contamination in the product was also demonstrated and a recovery trial highlighted the complete elimination of the tracer from the machine.
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High-Sensitivity Quantitation of Nitrosamine Impurities and NDSRI in Drug Substances and Products Using LC-MS/MSWebinar Date/Time: Wed, Dec 11, 2024 11:00 AM EST
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Flowsheet Models Modernize Pharmaceutical Manufacturing Design and Risk AssessmentIn-silico design facilitates process optimization and evaluation of process control strategies.
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Application of the Weisberg t-test for OutliersDetermining whether a data point is an "outlier" - a result that does not fit, is too high or too low, is extreme or discordant - is difficult when using small data sets, such as the data from three, four or five conformance runs. In this article, the authors demonstrate that the Weisberg t-test is a powerful tool for detecting deviations in small data sets.
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Ensuring Ergonomic Design in Sterile Transfer PortsIsolators should be designed to enhance working conditions for end-users.
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Evaluating the Sterile Barrier of Complex Drug Delivery SystemsMethods of validating and assuring container closure integrity are crucial for quality assurance.
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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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Validation of a Clean-in-Place System on a Capsule Filling MachineThe aim of this study was to validate the automated clean-in-place (CIP) system installed on a capsule filling machine to determine its ability to adequately eliminate contaminants. The results obtained from the proposed cleaning validation trial showed that all the soluble tracer was removed after the washing procedure. At the end of the CIP procedure, the discharged water had the same pH, phosphate content and total organic content as the supplied water. Lack of cross-contamination in the product was also demonstrated and a recovery trial highlighted the complete elimination of the tracer from the machine.
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Ensuring Ergonomic Design in Sterile Transfer PortsIsolators should be designed to enhance working conditions for end-users.
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Through-Vial Impedance Spectroscopy: A New In-Line Process Analytical Technology for Freeze DryingA new process analytical technology based on impedance spectroscopy has potential applications for characterizing product attributes during the freeze-drying process.
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Challenges and Strategies for the Downstream Purification and Formulation of Fab Antibody FragmentsAntibody fragments pose unique challenges in terms of recovery, purification, and formulation.
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Challenges and Strategies for the Downstream Purification and Formulation of Fab Antibody FragmentsAntibody fragments pose unique challenges in terms of recovery, purification, and formulation.
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Advancing Container Closure Integrity TestingThe revised USP Chapter Sterile Product Packaging-Integrity Evaluation gives best practices for obtaining reliable data in container closure integrity testing and recommends quantitative deterministic methods rather than probabilistic methods.
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Trends and Innovations in Continuous CoatingThe technique of continuous coating has undergone great change since it was introduced to the pharmaceutical industry more than a decade ago, and its benefits have multiplied.
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European Union Local Language Requirements and How Labelling Systems May Provide a SolutionThis article is intended to keep readers informed about the developments concerning the local language requirements for European Union member countries. The first part deals with the reasons why these language requirements are about to become more difficult to meet and the second part, based on recent application knowledge, offers some potential solutions.
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Facilitating Client Audits:The Contract Laboratory PerspectiveThe authors offer key steps for successfully facilitating the growing number of client compliance audits.
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Intelligent InspectorsCustomers are placing high demands on pharmaceutical manufacturers to produce sensitive, cost-effective and regulatory compliant inspection technology. This article examines how metal detection equipment suppliers can combine forces with manufacturers to provide state-of-the-art inspection systems, giving particular consideration to cleaning processes and regulatory issues.
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Formulation of Lactose for Inhaled Delivery SystemsDry powder inhalers (DPIs) contain a powder which, when required, is discharged and inhaled. The therapeutic drug is manufactured in powder form as small particles a few micrometres in diameter. In many DPIs, the drug is mixed with much larger sugar crystals, such as lactose, and the smaller drug particles attach to these excipient particles, improving entrainment of the drug upon inhalation. This article examines how the application and combination of versatile processes such as milling, micronizing, sieving and air classification can be used to manufacture dedicated lactose products for practically every possible combination of active and excipient blend in DPIs.
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Drug Encapsulation for Patient-Centric DosingEncapsulation technologies for solubility/bioavailability enhancement, controlled release, and formulation of drug combinations and patient-friendly dosage forms.
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Developing an Injectable Compound for a Dual- Chamber Delivery SystemPrefilled dual-chamber cartridges offer several advantages. Several steps should be taken to determine if a dual-chamber system is viable for a lyophilized injectable drug product.
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Selection of Suitable Drug and Excipient Candidates to Prepare Glass Solutions by Melt Extrusion for Immediate Release Oral FormulationsUsing melt extrusion to prepare glass solutions of poorly water-soluble drugs with hydrophilic excipients offers an exciting and advantageous alternative to existing formulation methods such as spray-drying and co-melting. Investigating potential methods to increase water solubility begins early in drug development. Techniques described in this paper show how only a small quantity of drug can be used to determine its suitability for melt extrusion, allowing the method to be considered at the same time as salt screening and particle size reduction work, and could speed up the formulation process.
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Optimizing Warehouse ManagementAlthough software and the overall warehouse management solution (WMS) are crucial tools, common problems include failure to put in place an efficient warehouse layout best suited to the products being handled, lack of knowledge of the inventory on hand, and inadequate preparation and training of personnel.
