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SCIENTIST SPOTLIGHT: November 2018

Name: Jasmine Mace
Alcami Site: Germantown, WI

How long have you been with Alcami?
I have been with Alcami since March 2014.

What is your role? 
I am an Analytical Scientist II.

What is the most rewarding part of your job?
It is very rewarding when I am presented with a difficult analytical method development and I find a way to deliver a solution to the client. Sometimes it takes some “thinking outside of the box” to arrive at a solution which satisfies the client’s needs for an analysis. The key for me is always asking the right questions:

  • Is this testing needed, or are there adequate tests being done to satisfy the quality attributes of the process/compound?
  • Are there any historical examples of how a similar problem was handled in the past?
  • Which techniques could potentially be used?
  • Did I think of what the test method could potentially affect downstream?
Topics: Alcami Voices

Alcami STEAM Outreach Efforts Aim to Inspire Students, Advance Workforce

Alcami expanded its Science, Technology, Engineering, Arts, and Math (STEAM) education initiatives this fall with three specialized outreach events designed to encourage high school and college students to pursue careers in chemistry, engineering, and other STEAM fields. 

On October 30, 2018, Divine Savior Holy Angels High School (DSHA) students got a behind-the-scenes look at Alcami’s Germantown, Wisconsin active pharmaceutical ingredient (API) Center of Excellence, as part of the company’s ongoing efforts to promote women in STEAM careers. The all-girls engineering class toured the campus, met with key female company leaders, and learned about potential career paths through interactive presentations.

Topics: Company News Alcami in Action

PART I: HPAPI Market Forecasts and Manufacturing Challenges

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.

The highly potent active pharmaceutical ingredient (HPAPI) market is one of the fastest growing CDMO submarkets, approaching a 9 percent compounded annual growth rate (CAGR). There is a continued industry focus on pipeline development oncology drugs, which by nature of indication is producing compounds that are increasingly potent.

Topics: Thought Leadership API HPAPI Manufacturing HPAPI

Case Study: Medicines Development for Global Health

In 2016, the not-for-profit Australian biopharmaceutical company Medicines Development for Global Health (MDGH) came to Alcami to initiate work on moxidectin, a novel new drug for the treatment of river blindness (onchocerciasis). The project utilized Alcami’s advanced analytical testing services and industry-leading accelerated turnaround time offering to meet critical New Drug Application (NDA) filing timelines. Now, the two companies are exploring new opportunities to help eliminate neglected tropical diseases that affect over 2 billion of the world’s most disadvantaged people.

Read this case study to learn more about how Alcami’s advanced analytical testing technology center supported MDGH's moxidectin’s US Food and Drug Administration (FDA) approval.

Topics: Resource Center Analytical Development

The Top Eight Most Asked Questions about Microbial In-Use Studies

According to Dr. John Metcalfe, “pharmaceutical companies go to great lengths to manufacture a drug product which is sterile, whether by terminal sterilization or aseptic processing. Equally important to the microbiological quality of the product at the time of product release is its microbiological quality at the time of patient administration.” This Q & A featuring microbial in-use studies with microbiological expert, Brent Harlow, will address the most common questions asked about these studies.

Topics: Analytical Testing Microbiology

White Paper: Insight into Orphan Drug Formulations and Regulations

The US Orphan Drug Act of 1983 characterizes an orphan disease as a rare medical condition that affects a population of fewer than 200,000 people. Rare diseases have various causes— most notably, 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).

The term “orphan disease” resulted 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 Orphan Drug Act (ODA) allows for the necessary financial backing of pharmaceutical companies to develop treatments for rare diseases (NIH, 2017), giving special status to a drug or biological product (drug) upon request of a sponsor. This status is referred to as orphan designation or orphan status.

Topics: Resource Center Oral Solid Dose Formulations Regulatory Compliance Orphan Drugs

Alcami Employee Recognized with Honor Flight

The nonprofit Honor Flight Network honors America’s military veterans for their sacrifices by transporting as many of them as possible to see the Washington, D.C. memorials of the wars they fought in, at no cost to them. Alcami employee and Vietnam veteran, Herman Anthony, was recently selected for an Honor Flight, and was accompanied by Milwaukee Brewers all-star relief pitcher, Corey Knebel. Herman received a hero’s welcome at the Milwaukee airport from Alcami colleagues, friends, family, and the general public. He recently spoke with Alcami's Marketing & Corporate Communications team to discuss his experience.

Topics: Company News Alcami in Action

Alcami President & CEO Elected as 1st Vice President of the Board of Directors of the Drug, Chemical & Associated Technologies Association

Stephan Kutzer, Ph.D., President & CEO of Alcami Corporation, has been elected to serve as 1st Vice President of the Board of Directors of the Drug, Chemical & Associated Technologies Association (DCAT) beginning November 1, 2018. Together with the ten other members of DCAT’s Board of Directors, Dr. Kutzer will help develop and guide the organization’s strategic plan in a manner to best serve the organization’s 500+ member companies.

Topics: Company News

Beyond the Label: Four Challenges to Serialization

Many pharmaceutical manufacturers are concerned about label design and placement to accommodate a serialized label. These are, of course, very legitimate concerns. However, there are much more complex issues at hand, including the importance of standardization, scaling information technology infrastructure, agility to accommodate regulatory changes, and data security.

Why Serialization Matters
The first objective of any pharmaceutical company is to deliver safe and effective medicines to patients. While historically there have been methods to provide product visibility and control along the supply chain, the processes have been highly manual, with paper-based record keeping being the prevalent modality.

Topics: Regulatory Compliance Serialization Supply Chain

ON-DEMAND WEBINAR: Submitting Samples through Alcami OnDemand™

Join Alcami for a webinar to learn more about submitting samples through Alcami OnDemand, a customer portal that provides clients unprecedented and rapid access and visualization into ongoing projects. 

Using Alcami OnDemand to submit Analytical Testing projects is a simple process that will save you time and streamline project tracking. This webinar will detail the finer points of online sample submission. We will show you how to build a sample submission project in Alcami OnDemand and walk you through the following processes:

Topics: Webinars Analytical Development Analytical Testing Alcami OnDemand