Name: Colleen Guthrie
Alcami Site: St. Louis, MO

How long have you been with Alcami?

I have been with Alcami for 5 1/2 years.

What is your role? 
Manager, Microbiology at the St. Louis site.

What is the most rewarding part of your job?
I am very proud to work with the St. Louis team.  Our team constantly displays dedication and accountability. The relocation of the laboratory has been challenging and rewarding.  I am proud of what we have accomplished through the hard work and commitment of our employees and support staff. I also find it rewarding to work with clients on difficult projects and assist in finding solutions that could lead to a life-saving drug.

Topics: Blogs

ON-DEMAND WEBINAR: Abuse-Deterrent Category One Testing: Syringeability Studies

As of July 2017, America’s opioid crisis has been declared a state of emergency. In order to help combat prescription opioid drug misuse and abuse, pharmaceutical drug companies are developing and commercializing drug products that have abuse- deterrent features. The FDA issued guidance in April 2015 for new drug applications (NDAs), and suggested guidance in March 2016 for generic abbreviated new drug applications (ANDAs) to aid in the formal evaluation of the abuse-deterrent nature of drug products. A crucial test for drug products that are abused intravenously are syringeability studies. Because most syringeability studies are performed exclusively in-vitro due to the hazardous nature of abuse-deterrent formulation excipients, accurate experimental design is crucial and carefully reviewed by the FDA.

Topics: Webinars Abuse-Deterrence

Stability: Back to the Basics - Part III

Part III: Measuring Shelf Life— Product Efficacy of API and Finished Drug Products

In this five-part blog series, Alcami scientific experts, Russell Crothers and Adam Keisker, go “back to the basics” to examine the importance of stability in pharmaceuticals.

The Federal Drug and Food Administration (FDA) states that “Stability studies should include testing of those attributes of the active substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The justification of individual and total upper limits for degradation products should be based on safety and/or efficacy consideration.”

Safety, quality and product efficacy work together in stability studies of Active Pharmaceutical Ingredients (APIs) and finished drug products. Through stability testing, pharmaceutical companies like Alcami have the ability to identify and trend shelf life and their affects on efficacy as samples are exposed to time, light and temperature.

Topics: Stability Blogs

Alcami Awarded Prosperity Prize at Business Ready Wisconsin Conference

Alcami’s Germantown, Wisconsin site was awarded the Prosperity Prize for Growth through Innovation by Economic Development Washington County (EDWC) at the recent Business Ready Wisconsin Conference award ceremony, Thursday, November 2, 2017, in West Bend, Wisconsin.

The Prosperity Prize is a highly prestigious award given annually to two Washington County businesses or organizations for their extraordinary contributions to the growth and prosperity of the region.

Topics: News & Events

Abuse-Deterrent Studies – An Interview with Angela Moore

As one of the key contributors to current abuse-deterrent studies being performed in the Alcami laboratory and having over 11 years of experience performing analytical testing in the pharmaceutical industry, Angela Moore was the perfect scientist to meet up with for a conversation on abuse-deterrent studies.

Moore was drawn to the pharmaceutical industry by having the ability to be a behind the scenes collaborator working on getting new drugs developed and brought to the market. She thrives on learning new technologies and being part of a team that can help save people’s lives through medicines.

Thanks for stepping out of the lab to share your experiences with abuse-deterrent studies. First of all, how would you explain your work with abuse-deterrence to a family member, for instance?
Thanks for having me. Being able to share what my team does is a great way of showing how patients come first in our line of work. I would say to my family that I research how people misuse or abuse long-acting opioid drug products in real life. After researching how people abuse them, I develop methodical scientific ways to mimic the abuse in a laboratory setting to see if new drug products can resist the abuse. This testing is meant to ensure that any new opioid products that are available by prescription cannot be easily used to get high in the future.

Topics: Abuse-Deterrence Analytical Development Blogs

Alcami Announces Manufacturing Agreement for Solasia’s Active Pharmaceutical Ingredient Darinaparsin

DURHAM, NC, USA – November 9, 2017 – Alcami, a leading provider of custom end-to-end development and manufacturing services for the pharmaceutical and biotechnology industries, today announces it has finalized manufacturing and quality agreements with Solasia Pharma, K.K. (TSE: 4597) for the clinical supply manufacture of the active pharmaceutical ingredient (API) darinaparsin, a novel mitochondrial-targeted agent developed for the treatment of various hematologic and solid cancers.

Topics: News & Events

Editorial: Right-First-Time Innovation Approach Drives Continual Investment

As published in Pharma's Almanac Q4 2017.

Efficient development of optimal routes and manufacturing processes for the production of increasingly complex small molecule APIs requires extensive expertise, advanced equipment and technology, and a right-first-time mentality. Demonstration of these capabilities has resulted in growing demand and a need for continual investment at Alcami’s Germantown, Wisconsin facility.

Topics: Editorials