FEATURE ARTICLES
Using continuous manufacturing technologies is a risk and often a barrier to implementing it. In this first article of a two-part series, the author provides a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with specific considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.
- Let’s Explore Packaging For Aseptic Manufacturing
- Optimizing Digitalization To Accelerate Your R&D
- Not All Plate Counting Technologies Are The Same
- Leveraging AI In Drug Discovery To Treat MS & Other Autoimmune Diseases
- FDA’s Digital Health Technologies Framework Addresses Important Challenges
- A Primer On ICH M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
- 5 Hot-Button Issues In Parenteral Packaging
GUEST COLUMNISTS
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Let’s Explore Packaging For Aseptic Manufacturing
When terminal sterilization is not an option, primary packaging materials have a fundamental role in preventing contamination. This article describes how packaging, including containers and closure systems, helps maintain sterility in aseptic manufacturing.
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Optimizing Digitalization To Accelerate Your R&D
Drug/therapy development has made significant leaps in innovation in recent years, but common issues that hinder progress still exist. Are you harnessing and optimizing your data for speedier drug development and quicker launch timescales? This article shares important recommendations.
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Not All Plate Counting Technologies Are The Same
While rapid microbiological methods have advanced, most microbiology lab tests remain reliant upon assessing microbial growth on agar plates. Discrepancies with plate counting, together with the limitations of human vision, have led to regulatory concerns. This article shares the advantages of automated colony counters. Keep in mind that not all automated plate counters are the same, though — you'll want to look for important functionality.
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Leveraging AI In Drug Discovery To Treat MS & Other Autoimmune Diseases
The advancement of artificial intelligence and machine learning algorithms means we can use large pools of genetic data to identify potential risk factors and disease-causing genes for multiple sclerosis and other autoimmune diseases. This author shares a three-pronged approach to analyzing data for AI algorithms, pitfalls to avoid, and AI for silico modeling.
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FDA’s Digital Health Technologies Framework Addresses Important Challenges
In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.
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A Primer On ICH M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
The International Council for Harmonisation (ICH)'s reflection paper on "Further Opportunities for Harmonisation of Standards for Generic Drugs," released back in 2018, is currently in public consultation stage and slated for adoption in November 2023. It provides recommendations on conducting bioequivalence studies during development and post-approval phases for immediate release solid oral dosage forms.
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5 Hot-Button Issues In Parenteral Packaging
Five key issues related to parenteral drug packaging came to the forefront of the PDA Parenteral Packaging Conference held in Venice, Italy, in April.
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The Global Market For Generic Sterile Injectables To Double In Value By 2032
According to new analysis at insightSLICE, the global generic sterile injectable market size was estimated to be $79.95 billion in 2022 and is expected to grow to reach $159 billion by 2032. What are the key factors and trends driving this growth? This author shares the key data-led insights.
PHARMA ONLINE WHITE PAPERS
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Software Tools For Pharmaceutical Lyophilization Process Development
Highlights from a webinar describing a software modeling tool developed to optimize conditions for the primary drying cycle while accounting for heterogeneity within and between batches of drug products.
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Pharma Manufacturing’s Digital Journey12/16/2021
The implementation of technologies and practices that improve efficiency, speed, and adaptability gives enterprises an edge while elevating the entire pharmaceutical industry. In this paper we detail the approaches pharma companies are taking to ensure long-term relevance in the value chain.
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The Power Of Modular Design9/30/2022
Learn how modular design has the potential to provide a solution for the increasing pressure and demand for biologics.
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8 Best Practices For Compliant And Quick Software Validation In The Cloud7/6/2022
Learn how to significantly lighten the software validation load for your cloud environment system with these eight key practices.
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Annex 11: The EU’s New Expectations For Regulated Computerized Systems8/27/2021
The Annex 11 Guidance is for the lifecycle of computerized systems to reflect the increased use and complexity of automated systems in the pharmaceutical industry. In this paper we cover the Scope of Annex 11, it's impact on medical device companies and its role in inspection readiness.
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Formulation Development Strategy For Early Phase Human Studies1/27/2022
Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.
PHARMA ONLINE APP NOTES & CASE STUDIES
- Novel Method For The Enrichment Of Full AAV Capsids
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- Quality System Metrics That Matter
NEWSLETTER ARCHIVE
- 06.05.23 -- Overcoming Characterization And Budget Constraints To Address Poor Solubility
- 06.05.23 -- Antibody Variants, Mechanistic Modeling, And High-Throughput Process Development
- 06.02.23 -- Discover Pharmaceutical Packaging Service Providers And Suppliers
- 06.02.23 -- Accelerate Your R&D With Digital Optimization
- 06.01.23 -- Pharma Process Equipment Suppliers Ready To Help
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS

What is Annex 1 and why is it important? What are the major changes? This e-book from Pharmaceutical Online, focuses on that the varying guidelines that will affect sterile pharmaceutical manufacturing operations.
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