October 7, 2021

Avoiding and Addressing Surprises in the API Manufacturing Process

When you’re developing and manufacturing your active pharmaceutical ingredients, the last thing you want to deal with is surprises. Unfortunately, even with the soundest methods, processes, and strategies, problems occur in manufacturing.
September 16, 2021

Starting Early: How to Ease the Process of a New Drug Application

Start early, document thoroughly. That’s the lesson for getting through the new drug application or biologics license application (NDA/BLA) process. Long before marketing approval, companies developing new products must apply to conduct clinical trials by submitting an investigational new drug (IND).
September 2, 2021

Planning, Preparing and Crafting the Drug Development Report

DSI has seen a lot of pharmaceutical development reports ranging from several hundred pages to a summary of conclusions attached to stacks of data. The latter can make things difficult when it’s time to put a regulatory filing together. It’s become clear that capturing development decisions and data from the outset in a living document is good practice and whether the data collected thus far is supporting development goals. It’s a reference point for what has been completed and what still has to be done.
August 19, 2021

Trust and Expertise: Defining The Value Of The Person-In-Plant

As sponsors have started to shift more and more of their manufacturing to outsourcing partners, relationship building has become an even greater priority. This is where the person-in-plant becomes an invaluable source for building a more trusting relationship with the contract research manufacturer (CMO). Essentially, a person-in-plant is a sponsor employee or, more often, a third-party expert consultant who is present at the contract manufacturing site to observe, support, and provide feedback to all stakeholders.
August 5, 2021

Why and When Filter Validation is Key to Bringing a Product to Market

Bringing a product to market is a long and complex one, even more so when developing a sterile product, such as injections, ophthalmic preparations, irrigation fluids, dialysis solutions, among others. The only method for removing microorganisms without adversely affecting the product is sterile filtration, and those processes need to be assessed through filter validation to ensure that the filter used to eliminate any microorganisms is the right one.
July 15, 2021

The Analytical Detective: Benefit-Risk Balance and the Analytical Testing Process

In any pharmaceutical development program, there are risk-benefit analyses being done to assist with decision-making processes. Expedited development presents a different balance to a company’s risk-benefit in order to bring a particular molecule forward as quickly as possible because of the potential benefits.