Resources

Why it can take so long to validate pharmaceutical manufacturing processes during site-to-site technology transfers and what can be done to speed it up

Why it can take so long to validate pharmaceutical manufacturing processes during site-to-site technology transfers and what can be done to speed it up

Process validation too slow? Here’s how to speed things up Technology transfers and process validation are an integral part of drug development and commercial drug product manufacturing. Successful technology transfer from site-to-site requires careful evaluation of manufacturing requirements and consequently applying that wisdom to validate a robust process that supports commercial-scale...

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Supply chain disruptions and their impact on quality and operations

Supply chain disruptions and their impact on quality and operations

Written by Goff Baker COVID-19’s impact on global supply chains as well as tectonic geopolitical shifts have resulted in considerable disruption, particularly to the contract development and manufacturing organization (CDMO) industry. Looking back, what is troubling about the supply chain challenges CDMOs faced during the past three years is that they were very similar to the issues plaguing...

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What is the best way to ensure a smooth technology transfer from one pharmaceutical manufacturing facility to another?

What is the best way to ensure a smooth technology transfer from one pharmaceutical manufacturing facility to another?

There are many benefits to using a pharmaceutical contract manufacturer (CMO). Many small to mid-sized pharmaceutical companies utilize them for developing their drugs when they don’t have their own facilities. For those companies that have already developed their pharmaceutical product or have licensed in a drug product, CMOs are a great place to transfer their existing product when they don’t...

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An overview of topical drug product forms – Part 2

An overview of topical drug product forms – Part 2

In part two of these blog posts authored by Dr. David Barnes and Lonnie Barish, we will discuss the various types of topical products (ointments, creams, gels, sprays, and lotions), detailing their characteristics both in terms of formulation and use. As discussed earlier, there has been an increase in the development of topical drug products as a way to deliver drugs locally to those surfaces,...

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