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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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Determining Low PPB Levels of Nitrite in Polymeric ExcipientsIn this paper, the authors introduce a method that combines ion exchange chromatography with an easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophotometric detection to allow high sample loading volumes without affecting resolution.
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Use Of RFID Asset Management Systems For Monitoring Analytical InstrumentationUtilizing integrated active radio frequency identification (RFID) and real-time asset management systems can yield commercial and compliance benefits.
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Change management: common failures and a checklist for improvementThough the pharma industry has improved its change management processes, there are still opportunities for improvement.
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Integrated Approach Facilitates Inhalation Drug DevelopmentThe choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.
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Viral Vector API Characterization of Product-Related ImpuritiesFDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.
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Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in BiomanufacturingDetermining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
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Advancing Spray-Dried Dispersion Formulation DevelopmentIn-vitro and in-silico tools can help predict in-vivo outcomes for low-solubility drugs formulated as spray-dried dispersions.
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Drug Shortages and Complying with FDA’s 21 CFR 211.110 GuidanceSusan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
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Pharmaceutical Knowledge Management: Experiences in Drug Development and ManufacturingKnowledge management has gained increasing importance in the pharmaceutical industry over the past 10–15 years
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A Novel Cell Lysis Method to Improve the Viral Vector Manufacturing ProcessResearchers demonstrated a new cell lysis method using a novel solution to improve viral vector production.
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Implementing Data Integrity Compliance in a GLP Test FacilityConsider how to apply ALCOA+ to a building management system in non-clinical laboratories.
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Improved Formulations to Enable Stable Delivery of BiologicsHow dry powder techniques can overcome limitations in biologics development and delivery to broaden routes of administration and global accessibility.
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Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical ProductsThis study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
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Integrated Approach Facilitates Inhalation Drug DevelopmentThe choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.
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Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.
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Printable Medicines: A Microdosing Device For Producing Personalized MedicinesThe authors describe a new method for the production of personalised medicines utilising ultra-precise microdrop printing technology.
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Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
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How to Meet Regulatory Challenges in the New YearWith 2007 projects wrapped up, or so we hope, forward-looking companies need to take their next step.
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Unpacking the Science Behind Data IntegrityWebinar Date/Time: Thursday February 24, 2023 at 11am EST | 10am CST | 8am PST
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Power Ultrasound and the Production of Mesoscopic Particles and Aqueous DispersionsThe authors discuss advanced sonocrystallization particle-engineering techniques for manufacturing mesoscopic particles.
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Servier: patience and passionYou don't have to spend any time in the company of its chairman to see that there is no other Big Pharma company like Servier.
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Formulation effects on the thermomechanical properties and permeability of free films and coating filmsUnderstanding a formulation's variable effects on its properties, especially film permeability, is key to designing a robust formulation and reducing variation of a finished product.
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Packing-Line Improvement Based on a Fault-Tree Analysis ApproachThis article focuses on upgrading and improving a packing process to comply with current good manufacturing practices. The authors sought to maintain proper quality assurance for finished products.
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Jake Sorofman Q&AQ: You have many years of experience in marketing and business development. What are the most significant changes you have observed in this time?
