Featured Articles
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Applying Quality By Design To Pharmaceutical Research And Development
12/1/2020
QbD is often discussed in the context of process development and manufacturing. We focus on QbD applied to R&D to drive better results throughout the drug development process.
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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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Is Your Partner Prepared For Your Scale-Up Challenges?
6/26/2019
Most early-stage companies are not equipped with the means necessary for successful scale-up and commercialization, it is critical you find a partner that can help you overcome the challenges.
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Managing Small Batch Formulations
An understanding of critical process parameters and impact on quality attributes related to the finished form can be especially challenging when working with a limited amount of an API.
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Five Trends Driving Lyophilization
9/20/2022
Learn more about the trends driving the need for lyophilization: biopharmaceuticals, scalability, a growing geriatric population, rising chronic diseases, and cold chain and storage.
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The Value Of Orphan Drug Designation
More than 90% of rare diseases still have no FDA-approved treatment, even though rare diseases affect more than 25 million Americans. Despite the opportunities in the orphan drug market, there are challenges that may act as barriers to entry.
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5 Key Factors For A Successful Tech Transfer
Each tech transfer comes with a unique set of complex processes that need to be understood. While it includes the transfer of analytical methods and manufacturing processes, there is also a human dimension to consider.
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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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Drug Repurposing Advantages And Strategies
Identifying new therapeutic uses for old, existing, or available drugs is an effective strategy in discovering or developing drug molecules with new pharmacological and therapeutic indications.
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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.