Articles
Accelerating Your Pharmaceutical Project – Part 2: The Project Technical Review
BACK TO RESOURCE CENTER Other Content Guide to Aseptic ManufacturingGuide to Oral Dose ManufacturingArticlesBrochuresCase StudiesPress ReleasesTrade ShowsVideos Accelerating the Start of Your Outsourced Pharmaceutical Project—the Role of the Project Technical Review By Devan Patel This is the second of two articles exploring best practices to streamline the underappreciated initial stages of a relationship between a…
Read MoreThe Importance of Analytical R&D to Sterile Fill-Finish
BACK TO RESOURCE CENTER Other Content Guide to Aseptic ManufacturingGuide to Oral Dose ManufacturingArticlesBrochuresCase StudiesPress ReleasesTrade ShowsVideos The Importance of Analytical R&D To Sterile Fill-Finish By Irinia Prudnikova Sterile Fill-Finish is considered among the most critical steps in the parenteral production process, ensuring patient safety, maintaining pharmacological efficacy, and product quality. Drug product development and…
Read MoreThe Value of Orphan Drug Designation
BACK TO RESOURCE CENTER Other Content Guide to Aseptic ManufacturingGuide to Oral Dose ManufacturingArticlesBrochuresCase StudiesPress ReleasesTrade ShowsVideos The Value of Orphan Drug Designation This year marked the 14th annual Rare Disease Day, which highlighted the reality that more than 90% of rare diseases still have no FDA-approved treatment. The orphan drug market is dedicated to…
Read MoreAccelerating Your Pharmaceutical Project – Part 1: Applying Thrust
BACK TO RESOURCE CENTER Other Content Guide to Aseptic ManufacturingGuide to Oral Dose ManufacturingArticlesBrochuresCase StudiesPress ReleasesTrade ShowsVideos Accelerating the Start of Your Outsourced Pharmaceutical Project by Applying Thrust By Devan Patel This is the first of two articles exploring best practices to streamline the underappreciated initial stages of a relationship between a drug developer and…
Read MoreDrug Development Executive Article: Pharmaceutics International, Inc: Getting Back to its Roots
BACK TO RESOURCE CENTER Other Content Guide to Aseptic ManufacturingGuide to Oral Dose ManufacturingArticlesBrochuresCase StudiesPress ReleasesTrade ShowsVideos Pharmaceutics International, Inc:Getting Back to its Roots Pharmaceutics International, Inc (Pii) has continuously evolved throughout its history as market and patient needs emerge and fade. There have been times when Pii developed and manufactured its own products and…
Read MoreEnhancing Oral Solid Dose Solubility and Bioavailability with Amorphous Solid Dispersions (ASD)
BACK TO RESOURCE CENTER Other Content Guide to Aseptic ManufacturingGuide to Oral Dose ManufacturingArticlesBrochuresCase StudiesPress ReleasesTrade ShowsVideos Enhancing Oral Solid Dose Solubility and Bioavailability with Amorphous Solid Dispersions (ASD) Pharmaceutics International, Inc. (Pii) will accelerate your early development through clinical studies for challenging, complex oral solid dose formulations with state-of-the-art spray drying technology. Spray-dried amorphous…
Read MoreOxygen Sensitive Drug Products
Oxygen is the second leading cause for quality degradation of pharmaceuticals, water being the first. While we typically think of packaging as the primary resource used to protect drugs from the negative effects of oxygen, there are things to consider during development and manufacturing to make sure excess oxygen isn’t simply packaged or bottled with the drug product.
Read MoreComplex Drug Development and Manufacturing—Steroids, Peptides, and Hormones
There are pharmaceutical therapies that are growing in their application and importance in patient care, and they occupy a scientific space between small molecules and biologics. They include steroids, natural and synthetic peptides, and hormones. They are complex, often pose solubility and stability challenges, and combine microbiological and chemical processes. They are also highly potent per dose and expensive–$3000-$4000 per gram.
Read MoreThe Art and Science of Tech Transfer – Transferring Vaccine Production
As I write this we just received promising news from a second drug developer, Moderna, that their COVID 19 vaccine candidate is estimated to be nearly 95% effective in the clinical trial. This comes a week after similar news was shared regarding Pfizer’s candidate. While most of us were confident in the abilities of the pharmaceutical industry to quickly deliver an effective vaccine, no one expected it to be done so quickly.
Read MoreDemystifying Highly Potent API (HPAPI) and Cytotoxic Drug Products
Thirteenth century philosopher Ibn Yami is credited with the origins of a design framework referred to as “Knowns and Unknowns.” He initially captured the idea in a verse, “one who knows and knows that he knows…his horse of wisdom will reach the skies.”
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