Featured Articles
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Self-Injection Of Biologics Made Easy
6/17/2022
Ready-to-Use (RTU) 3mL cartridge-based, single-use Pen Devices are specifically designed to ensure consistency of delivery for high-volume, high-viscosity injectable drug delivery systems.
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Supply Chain Transformation, 503B And Reducing Drug Shortages
9/11/2020
Currently there are two great forces at work that are disrupting traditional models for advancing drug therapies from discovery to commercial production and distribution. This transformation, when complete, will impact the biopharmaceutical supply chain significantly and potentially achieve outcomes that were considered impossible a short time ago.
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Snapshot Of The Parenteral Drug Delivery Market
6/17/2022
Growth in the development of parenteral drugs is driving demand for advanced drug delivery devices such as prefilled syringes, autoinjectors, and pen-injectors, growing segments in fill-finish manufacturing.
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Understanding Emergency Use Authorization (EUA)
Emergency Use Authorization (EUA) is a term that became part of the COVID-19 daily news briefings. What exactly is EUA? When is it used? How do the public health community, FDA, and drug developers authorize emergency use of drugs or other medical products?
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Navigating An Ever-Changing Landscape: The Role Of A CFO In A Private Equity Controlled Pharma Company
The role of Chief Financial Officer for a small-to-mid size pharma company controlled by private equity is a challenging one, especially since pharma companies with limited internal resources often rely on CDMOs for support. Learn how these CFOs can use their CDMOs to be more successful.
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Innovating During The COVID-19 Pandemic
Pharmaceutics International, Inc., (Pii) is a premier CDMO, offering unparalleled scientific insight and depth of product knowledge, while supplying high-quality dosage forms that enhance the lives of patients worldwide. Pii provides customized and flexible solutions across several dosage forms and has experience with a broad range of compounds.
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Optimizing Filling Technology To Minimize API Loss
New advances in filling technology offer solutions that can minimize lost API and eliminate sources of risk while still meeting the regulatory requirements for testing and quality assurance.
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Parenteral Drug Manufacturing — Innovation Begins With A Problem
6/11/2020
Developing manufacturing processes for complex parenteral drug formulations often presents some of the most challenging problems—and innovative solutions —pharmaceutical scientists and engineers face.
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Accelerate The Start Of Your Outsourced Pharmaceutical Project
In Part 1 of this series, we explore the best way to streamline the initial stages of forging a relationship between the drug maker and a contract development & manufacturing organization (CDMO).
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Phase-Appropriate Drug Development – Validation Process
The drug development process is among the most complex, costly, and regulated of human pursuits and the statistical chances of success are horribly low. However when we couple new trends in patient disease knowledge with a disciplined phase-appropriate process for drug development, a more cost effective, success-oriented model emerges. Let’s consider phase-appropriate development by applying it to process validation.