Featured Articles
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The Importance Of Analytical R&D To Sterile Fill/Finish
Parenteral drug product development and production rely on the careful integration of supporting elements, with analytical support as key. Analytical support is required at all stages of the product’s life cycle, from early development to commercialization.
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Meet The Scientist — Sundeep Sethia, Ph.D.
Many promising drug development candidates never advance beyond the preclinical stage because of bioavailability and solubility challenges. Dr. Sundeep Sethia has dedicated his life toward overcoming this initial hurdle in the drug development process.
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Meet Barbara Holland, Business Development Director
5/12/2022
Barbara Holland, Business Development Director at Pii, is a bit of a renaissance woman. Learn about her personal interests and why she came out of retirement to work with customers.
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Demystifying Highly Potent API And Cytotoxic Drug Products
The concept of development, process design, and manufacturing of drugs with a HPAPI or cytotoxic compounds should not be a mystery to drug sponsors using a CDMO. Gathering, organizing, and understanding critical risk data related to HPAPIs and cytotoxic drugs ensures appropriate controls are defined from concept to clinical batch manufacturing to commercial-scale manufacturing.
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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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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.
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Creating A New Dosage Form From An Approved Drug For A New Rare Disease Indication
7/22/2020
Cure HHT, a foundation representing patients suffering from Hereditary Hemorrhagic Telangiectasia, a genetic blood vessel disorder that causes bleeding in multiple organs, needed assistance in developing a formulation and filing an Investigational New Drug (IND) application with the FDA.
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Vaccine Capacity Musical Chairs
In the past six months, I’ve spoken to more vaccine developers than I have in the previous eight years, all of them searching for production capacity. Has the music stopped? Is it time to grab a chair?
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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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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.