Today’s drug device combination products market is experiencing rapid growth. Recent research indicates the market is expected to climb annually at a rate of more than 8%, reaching roughly $180 billion by 2027 from where its value stands today at nearly $125 billion.

In this issue our resident FDA gurus from Lachman Consultants address this dynamic market. Drug law expert Ricki Chase says the growth in generic combination products is no surprise for several reasons, all of which are driving patient compliance up. In short, combo products make the delivery of the drug easier for the user to consume; the partnering of the device with the drug can also help lower costs by supplying a single product; and combination products have allowed for more home use, allowing patients to have control of their medications without having to be in hospital or clinic.

However, with the movement of pharma into the combination product space, Chase says there have been challenges. Beginning on page 20, learn why she says medical devices and the quality system regulations (QSR) have unique aspects that do not translate exactly or sometimes even clearly into the usually well understood drug GMPs.

On the API front, in this issue Selwyn Lustman and Lina Cogan, two sourcing and procurement experts from LGM Pharma, offer key considerations when outsourcing API procurement and supply chain management. On page 26, in, “Secure Your API Supply Chain: Three Keys to Success,” the authors say small and medium pharmaceutical enterprises always face the temptation to go it alone and attempt to manage their entire supply chain. But, they argue, doing that means foregoing the expertise and experience a strategic partner can bring in terms of providing access to an extensive, qualified API partner network, market intelligence and regulatory services, and global drug product development and manufacturing facilities.

This month’s cover story on Pharma Lab Trends actually includes three separate features on the topic. First, contributing writer and internationally recognized expert in pharmaceutical analysis, Gary Ritchie, discusses Near Infrared (NIR) Spectroscopy, which has become a mainstay in the pharmaceutical as well as most other industries as an analytical technique because of its rapid, nondestructive, and noninvasive sampling capabilities. On page 30, in, “How Modern Near-Infrared Came to Be,” Ritchie says with sufficient training in spectroscopy and chemo-metrics, it is relatively easy to deploy at various points throughout the sample lifecycle for both qualitative and quantitative measurements.

Next, Daniel Kirschner, the executive director of analytical services at Cambrex’ Durham, NC site, provides an overview of what to consider when developing chromatographic methods and how a step-by-step, unbiased approach can pay off in reduced timelines and costs with robust results. In, “Rapid & Data Rich Chromatographic Method Development,” he says the develop-ment of analytical methods for assay and impurity profiling of new chemical entities (NCEs) in pharmaceutical analysis is a complex task that no single method development approach can satisfy (page 38).

Lasly, beginning on page 42, Rohit Shroff, senior vice president of global lab products at Avantor talks about how to maximize lab performance and value through comprehensive equipment management. From corporate labs to university centers to healthcare facilities, he says, researchers in biopharmaceuticals and life sciences rely on instruments and devices as a critical component of the work they do every day. “Empower Researchers to Focus on Science,” addresses why science professionals need to trust that their equipment, from pipettes and centrifuges to scales and freezers, is accurate and reliable.

Also, don’t forget, this issue includes Contract Pharma’s annual glossary beginning on page 50. It provides helpful definitions and examples of key industry terminology and vocabulary. It’s a year-round reference!



Tim Wright, Editor
twright@rodmanmedia.com