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The Buyer’s Guide to Pharmaceutical QMS v2For a pharmaceutical manufacturer, choosing the QMS that is right for you can be a daunting task. This guide offers a review of the obstacles most likely to hinder a quick, smooth, and effective QMS implementation.
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Effect of Binder Type and Binder Level on the Properties of Agglomerates Containing Lactose and Dibasic Calcium Phosphate DihydrateThe authors studied the effect of the combination of binders on the flow and compressibility characteristics of the agglomerates of binary combination of lactose and dibasic calcium phosphate dihydrate.
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Considerations for Monoclonal Antibody Bioprocess and Manufacturing ValidationRegulatory, analytical, and process concerns must be taken into account.
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Navigating the Complexities of Drug FormulationFor the pharmaceutical industry, drug formulation is a cornerstone, crucial for converting bioactive molecules into effective, stable, and patient-friendly medications.
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From Concept to Culture: Elevating GMP Compliance in Life SciencesWebinar Date/Time: Thu, Mar 14, 2024 2:00 PM EDT
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The Era of Digital Data in Bio/Pharma ManufacturingLaks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte, discusses the impact that digitalization is having on data generation and data integrity in bio/pharma manufacturing.
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Formulation of Sustained-Release Ketorolac Tromethamine PelletsThe authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.
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Navigating the Formality Spectrum in ICH Q9(R1)The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.
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Assessment of Nanosuspension Formulation for Intranasal AdministrationResearch suggests that intranasal nanosuspensions offer a promising way to formulate and deliver drugs that are poorly soluble in water to patients with chronic conditions.
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Contamination Prevention: How Single-Use Systems Can Ensure a Safe, Clean, and Efficient Bioprocess EnvironmentThe authors focus on how single-use systems effectively control three potential sources of common contamination: cross contamination, microbial contamination and biologic contamination of the process facility.
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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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Analytical Strategies for Cell and Gene Therapy DevelopmentDeveloping bioassay methods requires a new approach for cell and gene therapy drug development.
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The Ever-Changing World of Extractables and Leachables: Lessons learned and future challengesOctober 4, 2021 at 3pm BST | 10am EST | 4pm CEST Join global industry and regulatory experts as they discuss current hot topics in extractables and leachables (E&L) testing for pharmaceuticals, biopharmaceuticals and medical devices.
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Drug Digest: Emerging Therapies In all Shapes and SizesThursday April 28, 2022 at 11am ET | 10am CT | 8am PT In this new video series, Drug Digest, the Pharmaceutical Technology editors examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements. Join the editors as they speak with experts from Regulatory Compliance Associates (RCA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), and others.
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Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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Validating Single-Use SystemsThere are a number of validation approaches that can be adopted for single-use systems - all of which incorporate an established approach.
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Pharma Services Sector Poised for Continued Growth and ConsolidationThe CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.
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Public Trust in Medicine Quality as Public Health Challenges EmergePublic health challenges have highlighted the need for agility in maintaining the quality of medicines.
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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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Improving Aseptic Processing and Manufacturing NeedsWebinar Date/Time: Thursday, August 24th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Consultation on Proposals for the Future of UK Clinical Trial LegislationMHRA has opened a consultation on the proposed changes to clinical trial legislation in the UK.
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Polymer Influence on the Rheological Properties of Co-Processed Microcrystalline Cellulose and Sodium CarboxymethylcelluloseIn this study, researchers evaluated the colloidal microcrystalline cellulose (cMCC) suspending agent—a co-processed material of microcrystalline cellulose and sodium carboxymethyl cellulose (NaCMC)—by using a representative pharmaceutical-grade commercial version of cMCC.
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Accelerating Workforce Training on Single-Use TechnologiesTraining is crucial for supporting GMP operations in commercial-scale bioprocessing.
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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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Drug Product SecurityHigh-cost-per-dose large molecules can make a big impact on cell and gene therapy supply chain management.
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Seven Trends Shaping the Future of Pharmaceutical Formulation DevelopmentEmerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.
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The Influence Of Superdisintegrants On Immediate ReleaseWhen it comes to immediate-release tablet formulations, the choice of disintegrant can have a significant effect on the rate and extent of drug dissolution.
