Featured Pharma Online Editorial
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A Road Map For PAT Monitoring And Control
5/8/2025
Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.
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ICH Revises Q1 Guideline, Advancing Stability Testing Standards
4/24/2025
In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.
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Recent Developments Identifying Interactive Factors Affecting Tablet Scuffing Seen In The Aqueous Film Coating Process
4/16/2025
There are three primary root causes of tablet scuffing during the aqueous film coating process, and titanium dioxide plays a role. The author provides recommendations for addressing it.
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Growth And Trends In Topical Drug Contract Manufacturing
2/14/2025
Rising incidences of dermatological conditions, including acne, psoriasis, and skin cancer, are driving growth in topical drugs. Pharma companies are increasingly using contract manufacturers.
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2024 Trends In FDA Observations For Sterile Drug Manufacturers
1/30/2025
This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?
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11 Key Contributing Factors For Maintaining Sterility Assurance
1/6/2025
Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.
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Stage 3a: A Key Indicator For Process Validation Maturity
12/9/2024
Process validation's stage 3a serves to reconfirm the assumptions made during design space development and is particularly pronounced for new modalities and emerging processes.
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Oral Solid Dosage Formulation And Process Development: A Case Study
12/4/2024
This case study involves a drug substance currently in the preclinical phase. Discussion includes API physical chemical characteristics, enabling technologies, formulation assessment, and more.
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2024 Survey Findings: How Is The "Lab Of The Future" Becoming Reality?
12/3/2024
The Pistoia Alliance conducted a survey as a pulse check on which technologies the pharma/biotech industry is investing in and companies' progress integrating new tech into the lab.
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Enteric Coatings For Oral Solid Dosages: A Short Guide
11/19/2024
Enteric coatings play a pivotal role for drugs/APIs that need to withstand the harsh conditions of the stomach in order to dissolve in the intestine. This article shares an overview, commonly used excipients, and more.