Name: Matthew Collmeyer
Alcami Site: St. Louis, MO

How long have you been with Alcami?
I have been with Alcami since March 2018.

What is your role? 
I am the Sr. Manager of the Chemistry Laboratory Operations at Alcami's St. Louis, MO site.

What is the most rewarding part of your job?
The most rewarding part of my job is working with the chemistry team to tackle testing challenges and to see their dedication to ensuring we are doing as much as we can for our clients. Developing personnel through coaching and training is especially rewarding as well.

Your Manufacturing Milestones Matter.
Specialized to manufacture oral solid dose (OSD) forms, Alcami’s Wilmington, North Carolina site supports preclinical production through commercial launch and supply. Our cGMP manufacturing technologies, including low/high shear granulation and fluid bed drying capabilities, are arranged in flexible suites to support novel, advanced, and complex projects. 

In addition to OSD development and manufacturing, Alcami’s in-house analytical, stability, and packaging services provide an integrated and custom-tailored offering to help your product reach patients sooner.

In this two-part blog series, Alcami Senior Director of Global Manufacturing Science and Technology, Adam Kujath, discusses the market forecasts and the main manufacturing challenges involving highly potent APIs.

Read Part I: HPAPI Market Forecasts and Manufacturing Challenges

As demand for contract development and manufacturing of HPAPIs continues to increase from both new and existing relationships, it is important to anticipate and proactively expand to meet those needs. At Alcami, current market trends and our small molecule expertise drive our strategy to continue to invest in new capacity and expand our capabilities within this submarket.

The new elemental impurities regulations stress the importance of controlling all sources of elemental impurities in drug products. The regulations also impact all upcoming and current commercial drug products for human use. To comply with these regulations, it is critical to have an efficient, cost-effective, and agency-accepted approach.

Elemental impurities can contaminate or leach into a drug product from multiple sources (i.e. drug substance, excipients, water, equipment, and container closure systems), therefore, it is no longer acceptable to monitor the inlet raw materials only. A conservative risk-based approach is recommended, which should address all potential sources of elemental impurities. If it can be demonstrated that the elemental impurities present in the drug product are under control (less than the control threshold for three lots), then analysis at release is not needed.