Material Handling Featured Articles
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Statistical Methods For Comparing Small-Scale Models To At-Scale Biopharmaceutical Manufacturing
5/26/2021
As the final article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article discusses statistical methods for comparing SSM outputs to at-scale outputs and covers descriptive statistical methods, inferential methods, difference tests, equivalence tests, and more.
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Planning & Executing Small-Scale Model Qualification For Upstream & Downstream Biopharma Processing
5/19/2021
As the second article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article covers the current opinion on how to execute small-scale model qualification for both upstream and downstream SSMs and analytical setup.
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Implementing Small-Scale Models For Biopharmaceutical Development
5/12/2021
Small-scale models (SSMs) are widely used for process development and optimization, scale-up, technology transfer, process characterization, process validation, and more. This article from a BioPhorum Development Group discusses the applications of the models, including viral clearance, quality oversight, and design considerations for justification of SSMs.
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How To Use DMF Content To Support Your Application To The FDA
4/30/2021
A drug master file (DMF) is a voluntary regulatory application submitted to the U.S. FDA. It is used to provide confidential detailed information about the manufacturing, processing, packaging, and storing of APIs and/or human drugs. What are the types of DMF submissions, what is involved, and how does the FDA evaluate your submission?
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A Checklist For Risk Assessment Of Nitrosamine Impurities In Oral Solid Dose Drugs
3/12/2021
Nitrosamine impurities such as N-nitrosodimethylamine (NDMA) are being identified in high-volume drug products such as valsartan, losartan, irbesartan, and ranitidine at levels well above the acceptable daily intake limits. The credit for identifying the higher NDMA levels goes to an independent pharmacy that tests every batch it dispenses, exposing limitations in drug substance and drug product post-approval change assessment and analysis requirements at pharmaceutical manufacturing organizations.
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Ready-To-Use Excipients Can Now Solve Five Key Functional Challenges
12/15/2020
The market for oral drug products with an immediate release profile continues to move towards the development of more complex dosage forms designed to address specific functional or application requirements. While each formulation is different, customers most commonly want solutions to some combination of these five key challenges.
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Enabling Enteric Protection And Rapid Release In The Upper Small Intestine
10/5/2020
For many complex drug products targeting the small intestine or ileocolonic region, enteric protection on its own is insufficient to maximize absorption and enhance bioavailability.
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How To Control And Modify The Release Of Today’s Insoluble, Potent APIs
8/12/2020
Synchronizing and controlling API delivery, extrusion-spheronization is a robust technique offers pharmaceutical companies a reliable, efficient way to manufacture today’s most effective patient-centric therapeutics.
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How Can You Get Two Or Three APIs To Play Nice In One Capsule?
7/27/2020
Oral solid dose (OSD) delivery remains the most popular route for administering drugs. Market forces are prompting pharmaceutical companies to pursue a broad array of OSD development strategies to make their active pharmaceutical ingredients (APIs) and formulations therapeutically effective and patient friendly. One choice that is growing in popularity to control dose frequency and side-effects are compressed, tablet form multiple-unit pellet systems (MUPS).
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Identifying Difficult-To-Clean Surfaces In Manufacturing And Packaging Equipment
4/15/2020
This article describes a practical risk-based approach for assessing and identifying the surfaces, areas, or sites of manufacturing and packaging equipment that are cleaned upon completion of oral solid dosage manufacturing production.