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The Advantages of a Cross-Functional Staff Model in Pharmaceutical Manufacturing

As a CMO, Singota has chosen a cross-functional staffing model, spanning the functions of sampling/dispensing, formulation, filling, and finishing. Cross-functional staffing entails cross-training so that each employee can make the most of the skills they bring to the company, while acquiring new skills and perspectives.

Characterizing Novel Microparticle-Encapsulated Drug Formulations

In the previous blog post, we addressed the challenge of successfully formulating such compounds for oral administration. However, once you have successfully encapsulated an API, the next task is to characterize that product and understand its release kinetics.

Initial Considerations When Formulating Microparticle-Encapsulated Drugs

In part 1 of a 2 part blog series, we will explore some of the critical factors to consider when beginning work with these types of formulations.

The Internal Audit Process: How Your CDMO Keeps Tabs on Its Service Quality

When a pharmaceutical company engages a Contract Development and Manufacturing Organization (CDMO) to provide services, the most fundamental assumption is that the CDMO adheres to Good Manufacturing Practices (GMP). What entitles the CDMO to make that promise? The short answer is, it conducts regular audits of its own staff and business processes.

Contingency Planning: Hope for the Best, Be Prepared for the Worst

This time of year, we always reflect on one of the most important tasks for any organization—being prepared for the unexpected. It is important to have a contingency plan at every point in the pharmaceutical supply chain — for every organization that has a role in that supply chain.

5 Stirring Stability Testing Facts

People who are not familiar with pharmaceutical development often express surprise and disappointment regarding the time and cost to bring new pharmaceuticals to market. Here are some interesting facts about stability testing: