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Allison Irrera

Allison Irrera

Allison Irrera joined Alcami in 2016. Her journalism and communications background dates back to the Columbus Telegram newspaper in 2001. Prior to Alcami, Allison worked on film and television productions for HBO, Twentieth Century Fox, FX Productions, and New Line Cinema. Allison holds a Bachelor of Arts degree in English from the University of Nebraska Lincoln, and is currently pursuing her MBA at the University of North Carolina Wilmington.

Recent Posts by Allison Irrera:

Agency-Accepted Testing and Filing Strategy for Elemental Impurities

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. 

Topics: Analytical Testing Elemental Impurities Regulatory Compliance Analytical Development

Formulating for Orphan Indication Drug Products

According to the US Orphan Drug Act of 1983, a rare disease is defined as a condition that affects fewer than 200,000 people. The term orphan disease originated from pharmaceutical companies not having the resources to design and scale-up formulations to treat these diseases due to the lack of financial support for such highly specialized programs. The need for financial backing resulted in The Orphan Drug Act of 1983 that gave companies a means to develop treatments for rare diseases (NIH, 2017).

Rare diseases are caused by various reasons— most notably by genetics. However, the National Institutes of Health (NIH) states, “many rare diseases, including infections, some rare cancers, and some autoimmune diseases, are not inherited. While researchers are learning more each year, the exact cause of many rare diseases is still unknown” (NIH, 2017). Almost half of those affected by rare diseases are children (Global Genes, 2018).

Topics: Thought Leadership Drug Product Formulations Orphan Drugs

Considerations for Abuse-Deterrent Category One Syringeability Studies

The use of opioid medications for pain management continues to increase, generating an inevitable association with abuse and addiction. Government officials and pharmaceutical professionals alike are in need of risk mitigation approaches (Katz, 2008). The Abuse Deterrent Access Act of 2018 requires Medicare and Medicaid to report to Congress the availability of abuse-deterrent opioid pain treatments. The bill is meant to decrease the amount of barriers for their enrollees (Carter, 2018).

The U.S. Department of Health and Human Services (HHS) has estimated that in 2016, the most recent year for which complete data are available, over 42,249 Americans died from opioid overdoses, the most of any year on record. More than 2.1 million Americans had an opioid use disorder (addiction) in 2016, with economic costs from the epidemic estimated to be as high as $504 billion dollars (Johns Hopkins University Bloomberg School of Public Health, 2018).” Pharmaceutical companies have responded to this need through more stringent abuse-deterrent formulations and studies.

Topics: Thought Leadership Abuse-Deterrence

Beyond the Bench: A Century of Experience

The second edition of the Beyond the Bench series features three of Alcami’s longest tenured employees. Meg, Karen, and Sally have worked at Alcami and its legacy companies over a century, collectively. These women share in common not only a long history with the company, but they are all also great at sharing their knowledge. Please meet Meg, Karen, and Sally. 

Alcami applauds your loyalty and dedication. You are all valued, expert contributors at your sites! Please introduce yourselves and paint a picture of your start with the company .

Topics: Thought Leadership Alcami Voices

Editorial: Is industry ready for the serialisation shake-up?

Alcami recently authored an article featured in Chemistry World titled "Is industry ready for the serialisation shake-up?"

The regulation few outside of pharma have heard about

Within the next year, pharmaceutical industries in the US and EU will undergo what could be considered one of the greatest regulatory shake-ups in the modern era. Government regulation – coming into force in late 2018 and early 2019 for the US and EU respectively – dictates that all pharmaceuticals be subject to track-and-trace capabilities, also known as serialisation.

Topics: Thought Leadership Editorials Serialization

Editorial: Transparent and Timely Testing

Alcami recently authored an article featured in Speciality Chemicals Magazine titled "Transparent and Timely Testing." 

Analytical testing is a pre-requisite for the majority of products that use specialty chemicals, but it can be time-consuming and complex. CDMO Alcami outlines the advantages of using a CDMO and introduces its Alcami OnDemand program management portal, which offers transparency and quick turnaround times.

Topics: Thought Leadership Editorials Analytical Testing Alcami OnDemand

Beyond the Bench: Analytical Development and Professional Growth

Meet Courtney Reichert. She’s always on the go. From representing Alcami in charity races to mentoring new analysts in the labs, Courtney is the epitome of the Alcami Way. Her sense of awe for all things science is exemplified in her dynamic background in both analytical testing and biotechnology testing and research. Courtney is currently part of the analytical testing team. Based out of Alcami’s Wilmington, NC labs, she also travels to the Durham, NC and Charleston, SC labs to train analysts and share her experience and enthusiasm.

Fresh out of a United Way planning meeting, Courtney offers to talk with us to gain a better understanding of analytical testing and offer advice to young professionals.

Thanks for taking time out of your busy schedule to talk. Did you grow up knowing that you’d be a scientist?   
Hi, I am excited to share my views! Growing up, I had a love for all things science. There was never a moment in my life that I doubted what I wanted to do. There is always knowledge to be gained and so much more to discover in the world. Biology is all around us. We can use virtually any living cell or organism and manipulate it to discover something new. The limit is never-ending to what you can learn.

Topics: Thought Leadership Analytical Testing Analytical Development Alcami Voices

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: Thought Leadership Abuse-Deterrence Analytical Development

Filter Validation – An Interview with Stacey Ramsey

Joining Alcami in 2015, Stacey Ramsey, a senior scientist specialized in microbiology, is a scientific expert on microbial retention. Ramsey’s work focuses on the clinical stages of a drug product which compliments her experience in process development and method development in microbiology. Being part of the development process goes beyond running tests on lab samples, which allows Ramsey to showcase her passion while being a fundamental member of the Alcami development process team.

Q + A

How would you explain filter validation to someone outside of the pharmaceutical world?
From a big picture perspective, filter validation is filtering out microorganisms from a lab sample. In other words, it’s when you have a drug product that it is sterilized by means of a filter. In order to be able to filter out microorganisms, the filter has to have such small pores that it excludes bacteria and, therefore, you’re filtering out bacteria.

Topics: Thought Leadership Analytical Testing Filter Validation Microbiology