Material Handling Featured Articles
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Navigating OSD Formulation Development And Leveraging CDMO Partnership
4/17/2024
Collaborating with an experienced CDMO can provide the expertise and facilities needed to navigate oral solid dose formulation complexities and ensure compliance with regulatory frameworks.
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Pharmaceutical Solid-State Studies
4/9/2024
Solid-state characterization meticulously analyzes the physical properties of a drug in its solid form. Understand how this analysis is integrated throughout the drug development lifecycle.
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Process Development With “The End In Mind” For Startups
3/20/2024
We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.
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2024 LIMS Trends
3/15/2024
The laboratory information management system (LIMS) landscape in 2024 is a dynamic one, driven by accelerating advancements in technology and evolving industry needs. This article shares the four key trends.
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A Solvent-Free, Fusion-Based ASD Manufacturing Process
3/5/2024
Explore a solvent-free alternative for the production of amorphous solid dispersions (ASDs) that not only improves manufacturability but also reduces the carbon footprint of ASD manufacturing.
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Early Development Considerations For NCE Success: Quality Systems
3/1/2024
Leveraging robust quality systems can improve efficiency throughout the product development lifecycle and help companies avoid unnecessary knowledge and tech transfer, saving both time and cost.
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Modified Release Formulations: Extending Drug Commercial Lifecycle
3/1/2024
A CDMO with expertise in modified-release dosage forms can provide valuable assistance in formulation development, processing considerations, analytical challenges, and regulatory requirements.
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Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety
2/14/2024
Layers of protection analysis (LOPA) is a risk tool that focuses on the strength of controls that are currently in place and enables a cross-functional team to dive into the ways that the controls may fail. The article outlines the application of LOPA to drug product and facility cross contamination.
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Is Pre-Compression Tablet Thickness A True Critical Operating Parameter?
2/12/2024
As recently as Nov. 2023, the topic of how pre-compression tablet thickness is viewed raised its head once again in an FDA inspection at a generic pharmaceutical company in India. This control is available on all modern tablet presses, yet instructions for its use are vague. This article shares how to use this control correctly and to be better prepared for an agency inspection.
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FDA Issues Final Guidance: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
2/6/2024
Benzene contamination in pharmaceuticals has led to product recalls and increased scrutiny in recent years. Recently, the FDA has asked the USP to remove a few monographs from the compendium due to safety concerns related to benzene's carcinogenic properties, and the agency has issued a new guidance to help industry navigate the reformulation of such drug products.