Technology transfer from pharmaceutical companies to contract development and manufacturing organizations (CDMOs), is critical to successful drug development. When you consider the skills, knowledge, intellectual property, technologies, and manufacturing methodologies being…
A company’s ability to pivot and adapt — its agility — is more than just an asset. In today’s dynamic contract manufacturing landscape, it’s a necessity. Agility allows a CDMO…
Welcome to Part 2 of our series on managing API particle size. (You can find Part 1 here.) Today we’re talking about some of the new and emerging technologies that…
API particle size is a key consideration in manufacturing quality pharmaceutical products, however, particle size is also notoriously difficult to control during manufacturing. Despite the difficulty, it’s essential to get…
Selecting the right pharmaceutical contract manufacturing partner for Phase 3 clinical and commercial supply is challenging. There are several critical qualifiers you need to consider: Do they have the expertise…
To be successful, pharmaceutical innovators and biotech organizations need to optimize production and achieve higher yields of their active pharmaceutical ingredients to make products more cost-effective. To realize these results,…
The development of drug substances heavily depends on a thorough and precise understanding of its different processes. One of these critical steps is crystallization, which has a significant impact on…
In Part I of this two-part series, we explored sourcing and supplier management of Regulatory Starting Materials (RSMs), and how effective designation and justification of RSMs begins with supplier market…
Demands on a drug’s synthetic processes naturally evolve during its lifecycle. Scouting alternative methods for synthesizing active pharmaceutical ingredients (APIs) early in process development — before they are needed by changing…
Seven years ago – in March of 2013 – we published a blog post on 5 Things to Consider When Looking for an API Supplier. Because seven human years equals…
