Authors
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Reducing the Time to Develop and Manufacture Formulations for First Oral Dose in HumansThe authors discuss approaches to delivering formulations fo first-time-in-human dosing.
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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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Production Information MangementThe author discusses the use of batch control systems for the collection and management of production data.
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Is There Such a Thing as a Best-in-Class Lab? Benchmarking of QC OperationsThis article investigates what defines a best-in-class QC lab based on experience of implementing operational improvement projects in world-class labs. It includes an assessment of a benchmarking process, a case study of improvements made as a result at one company and findings on what constitutes best-in-class for QC labs.
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The Art of Changing QC Testing Processes to Build Effective Data Integrity Compliance***Now Available!*** Thinking about changing QC testing methods? Join Charles River’s Alan Hoffmeister for The Art of Changing QC Testing Processes to learn why saying yes to change can benefit you in the long run. *** On demand until March 30, 2022.***
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UK Biotech Gains MomentumTo gain insights into the current trends of the biotechnology sector in the United Kingdom, Pharmaceutical Technology Europe spoke with Steve Bates, chief executive officer of the BioIndustry Association (BIA), the trade association for biotech companies in the UK.
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An Alternative to the USP Disintegration Test for Orally Disintegrating TabletsThe authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.
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Extractables and Leachables: Best Practices to Ensure Patient SafetyThe author presents best practices for extractables and leachables.
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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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Do you really know your relative humidity calibration vendor?Welcome to Pharmaceutical Technologies Podcast Series, "Do you really know your Relative humidity calibration vendor?" Our sponsor, Rotronic, is a technology leader in the field of relative humidity measurement. Rotronic operates company subsidiaries in The Americas, Europe, and Asia and is represented worldwide. Be sure to visit their web-site at www.rotronic-usa.com for further information.
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Cleanability of Pharmaceutical Soils from Different Materials of ConstructionThe authors look at the cleanability of pharmaceutical soils from a variety of materials of construction to determine the relative ease of cleaning and explore potential grouping strategies as part of a comprehensive cleaning validation program.
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21 CFR Part 11: The New Draft GuidanceOn 20 February 2003, the US Food and Drug Administration (FDA) published a new draft guidance relating to 21 CFR Part 11. The new guidance mainly affects the compliance requirements of systems with a low risk and low impact on product quality; however, systems with a high risk and high impact on product quality, such as chromatography data systems or laboratory information management systems (LIMS), remain unaffected, as this article describes.
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Understanding the Flow Behavior of MaterialsA rheometer and powder flow tester can measure how pharmaceutical materials, such as powders from a hopper, flow.
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Advanced Continuous Manufacturing of DrugsAdvanced continuous manufacturing with modular components is emerging as a preferred platform to produce APIs.
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2020 Bio/Pharma Virtual Congress*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021
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The Validation and Implementation of a Chromatography Data SystemThis article describes the approach used to upgrade a chromatography data system. The upgrade was required to meet the current regulatory requirements for good laboratory and good manufacturing practice. Compliance with 21 CFR Part 11 for electronic records and electronic signatures was also a major consideration. The procedures used for this project followed the software development life cycle (SDLC) and involved the co-ordination of personnel from the software vendor, the user department, information technology and quality assurance.
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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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Investigational Product Expiry ManagementKurt Lumsden, Director, eCDS Client Services at PAREXEL Informatics, discusses the use of interactive response technologies in investigational product expiry management.
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Perspectives on Quality Attributes of Drug Products Containing NanomaterialsIn this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.
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Variables Affecting Reconstitution Time of Dry Powder for InjectionThe authors describe the factors affecting reconstitution time of dry powder for injection and classifies them as intrinsic and extrinsic parameters.
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Understanding and Implementing Efficient Analytical Methods Development and ValidationAnalytical methods development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products.
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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.
