Featured Articles
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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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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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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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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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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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Oxygen Sensitive Drug Products
Primary packaging is thought of as the first line of defense against the negative effects of oxygen. This article highlights other areas to consider that can help avoid drug quality degradation.
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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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Preventing Cross-Contamination – Operating Beyond cGMP
One critical outcome universally accepted by the pharmaceutical industry is that cross-contamination of drug substances and products in manufacturing lines cannot occur. However, the conditions driving modern pharmaceutical development and manufacturing have increased the risk of cross-contamination.
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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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Applying The Four Dimensions Of Sustainability To Create Capacity That Delivers Results Faster
There are no shortcuts to growing capacity that delivers results faster and maintaining it is difficult. The key ingredient in growing enterprise value is sustainability. Learn how by applying the principle of sustainability using its four dimensions, finite resources are more wisely used with extraordinary results, lead time from concept to commercialization is greatly improved, and patients receive better medications faster.