May 4, 2022

Project Management: A Complex Necessity

Many pharma and biotech startups may question the idea of whether a Project Manager is really useful; is it simply another layer to add to the complex array of personnel and job responsibilities? There are a number of tools available; most commonly recognized among these is the classic Gantt chart – so why add another person to the mix just to manage that?
April 20, 2022

Virtual Audits: A New Frontier

In the era of the coronavirus pandemic, all aspects of life were shown to have had the rug pulled out from underneath them. Each facet of our working and personal lives has gone remote. This virus put an end to travel and in-person work processes. Looking at pharmaceutical companies, there was a need to adopt virtual options to complete critical processes by the corporations and outsiders’ involvement.
April 6, 2022

Nitrosamine Assessment

The FDA has been investigating the presence of nitrosamine impurities in certain drug products. Since 2018, several drug products including ARBs, ranitidine, nizatidine, and metformin have been found to contain unacceptable levels of nitrosamines. Nitrosamines are classified as probable human carcinogens based on animal studies and there has been a pressing need to remove the risk to patients.
March 23, 2022

API PROCESS VALIDATIONS: A Broadway Analogy by Jim Mencel, PhD

Before the stage is set and the curtain rises for a debut performance, the time-consuming process of putting together a Broadway show is the perfect analogy used by Jim Mencel, Senior Drug Substance Consultant at Design Space InPharmatics, to describe process validation for Active Pharmaceutical Ingredients (APIs) when preparing for filing with the FDA.
March 2, 2022
Introduction to Chemistry, Manufacturing, and Controls (CMC) Regulatory Strategy

When a Decision Decides the Outcome

Beginning with spring training through the dog days of summer to the stretch drive, every decision on and off the field can affect the postseason outcome.
January 19, 2022

The Pros and Cons of Outsourcing Manufacturing to China

Trust is important when selecting a contract manufacturing organization (CMO), particularly when offshoring. With more biopharmaceutical companies looking to China-based CMOs, companies need to understand both the opportunities and the challenges the market presents.