Featured Articles
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Tech Transfer For Oral Products
With the right CDMO, a proper tech transfer offers an opportunity to re-examine quality, process procedures, and supply chain issues, including provider partnerships.
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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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Meet The Scientist — Irina Prudnikova
Analytical research and development (R&D) works in close collaboration with formulation and process R&D to support the overall development process. Irina’s team is often the catalyst for transforming a development candidate into a viable drug formulation that improves patients' lives.
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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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Enhancing Oral Solid Dose Solubility And Bioavailability With ASD
Spray-dried ASD (amorphous solid dispersions) technology may be the catalyst needed to overcome solubility and bioavailability challenges for your promising oral solid dose candidate.
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CDMO Innovation For The Future Pharmaceutical Supply Chain
We have a longstanding mantra, “challenges frame opportunities.” This applies to how we intentionally innovate, modernize, and introduce new capabilities and expand capacity.
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Scaling Aseptic Pharmaceutical Production During Uncertainty
Aseptic production and fill/finish operations are complex, and unexpected challenges should not disrupt the outcome of delivering needed pharmaceutical products to patients.
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Oral Solutions & Suspensions: The Art Of Pharmacy
5/12/2022
Despite advantages, there are challenges associated with liquid dosage, such as stability and palatability, parameters that need to be considered in the design.
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The Case For Repatriating The Pharmaceutical Supply Chain
The pandemic has broadcast a loud call to bring our pharmaceutical supply chain back to the U.S. to provide greater regulatory control and patient, economic, and workforce benefits.
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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.