Articles

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...

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 many pharma manufacturers...

As part of Bora Pharmaceuticals’ global growth strategy, the company successfully completed the acquisition of GSK's Mississauga, Ontario (Canada) facility in 2020. Representing Bora’s first manufacturing facility in North America and its headquarters in the region, the Mississauga site is integral to the company’s global contract development and manufacturing organization (CDMO) business...

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...