03.26.24 -- A Structured Approach To Regulatory Information Management Vendor Selection

Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs or result in no product at all.

While a few red flags are common during any submission, several occurring in concert can precipitate a submission crisis. Learn how these can be avoided.

Small-scale aseptic filling presents a unique set of challenges. Learn what to look for when evaluating small-scale aseptic filling technology.

Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

Once a company has demonstrated proof of concept, it is critical to consider process elements like scalability, sourcing raw materials, and GMP adherence.

ASDs improve bioavailability to provide acceptable in vivo performance, but production requires an enabling technology. Spray drying and hot melt extrusion are among the most widely applied.

Understanding the root cause of a supply chain issue helps set realistic timelines for customers and generates more collaborative problem-solving efforts between drug manufacturers and their suppliers.

Learn in detail about high voltage leak detection (HVLD), packaging applications that can be inspected with HVLD, and how to determine the best leak-testing method for your application.

Ensuring critical oral solid dosage (OSD) therapeutics reach patients successfully relies on the ability of developers and manufacturers to navigate the inherent issues surrounding their increasing complexity.

Review a method for rapid and consistent global characterization of leachable metals- or peroxide-stressed immunoglobulin (Ig) G1 monoclonal antibodies (mAbs).

We discuss the trends in new molecular formats, which are one of the current drivers of renewed interest in fermentation technologies, along with some of their challenges. 

Finding a partner with integrated services is crucial for accelerating timelines and accessing solutions with comprehensive expertise, all while removing risk from the drug product life cycle.

Providing personnel protection when working with HPAPIs is very tricky. In this case, a containment solution was designed for a benchtop vacuum oven process.