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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

ON-DEMAND WEBINAR: Elemental Impurities Q&A - Ask Our Experts

With less than three months until the methods outlined in USP General Chapter <231> are retired, there is still much to discuss.

We’ve presented everything you need to know, including potential contamination sources, but we know there are still questions left unanswered.

This webinar will feature an extended Q&A with our panel of experts to answer any questions you have regarding what lies ahead.

Topics: Webinars Elemental Impurities

Alcami Wins Prestigious Business of the Year Award from St. Louis Mayor

On Friday, October 13, 2017, Alcami proudly accepted the Business of the Year award from St. Louis Mayor Lyda Krewson and the St. Louis Development Corporation at the annual Mayor’s Business Celebration Luncheon. Alcami was one of eight recipients of the prestigious award, which recognizes St. Louis businesses for their significant economic contributions to the city and commitment to growth and development.

Alcami’s St. Louis Site Director, Ryan Williams, was amongst over 1,250 guests to attend the event at the Marriott St. Louis Grand Hotel and joined Mayor Krewson on stage to accept the award.

Topics: Company News Alcami in Action

SCIENTIST SPOTLIGHT: October 2017

Name: Stephanie Jarman
Alcami Site: St. Louis, MO

How long have you been with Alcami?

I began working with Alcami in March 2017.

What is your role? 
I am a Quality Specialist III at our St. Louis, MO site.

What is the most rewarding part of your job?
Providing guidance and advice to the lab to ensure decisions and actions are made in a compliant manner.  In addition, trying to provide the lab with the most efficient processes to follow while still maintaining a state of compliance.

Topics: Alcami Voices

Alcami Establishes International Sales Office in Japan

Durham, NC (USA) – October 19, 2017 – Alcami Corporation, a leading provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, today announces the launch of its international sales office in Tokyo, Japan. The company is expanding its presence in Japan to remain at the forefront of market demands and strengthen business relationships in the region. The new branch will provide a home base for Alcami’s local customers and serve Japanese companies interested in developing and manufacturing products for launch in the U.S. market.

Topics: Company News

8 Characteristics of a State-of-the-Art Highly Potent API Facility

HPAPI manufacturing is a demanding enterprise, but given the robust growth within this segment of the pharmaceutical industry, it is critical to have the right facilities and capabilities in place. Alcami has been dedicated to this pursuit, and our efforts culminated in the opening of our Germantown, WI, HPAPI facility. It is unquestionably state-of-the-art, so we took the opportunity to reflect: Which characteristics make it an industry-leading HPAPI facility?

1. State-of-the-art containment
Highly effective containment is the most important aspect of designing an HPAPI facility.
While many high-potency manufacturers rely on personal protection equipment (PPE) for primary control, PPE should be a secondary or even tertiary measure within a state-of-the-art facility.

Topics: Thought Leadership HPAPI

Alcami Technical Evaluations Specialist Speaks at University of Wisconsin-Washington County STEM Club

On Wednesday, October 11, 2017, Bill Wobig, Alcami technical evaluations specialist, held a seminar for the University of Wisconsin-Washington County STEM Club at the university’s Collins Science Building in West Bend, Wisconsin.

Wobig, a University of Wisconsin-Washington County (UW-WC) alumnus and former UW-WC STEM Club student president, delivered a presentation entitled: “Native Protein Electrophoresis: A UW-WC Alum Success Story!” to 30 undergraduate students interested in or pursuing majors in the STEM fields.

Topics: Company News Alcami in Action

Stability: Back to the Basics - Part II

Part II: The Impact of Stability on the Safety of API and 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.

Can you answer any of these questions?
- Exactly how safe are your drugs?
- Do you know the active ingredients in the pills that you are taking?
- What is the purpose of your medication?

Let’s be honest. Most people take these questions for granted. One quality attribute that all companies in the pharmaceutical fields strive for is the safety of drug products.

Topics: Thought Leadership Stability

ON-DEMAND WEBINAR: Approach to HPAPI Suite Design in a Multi-Use Facility

Join Alcami for a webinar to learn more about the design approach to highly potent active pharmaceutical ingredient (HPAPI) suite design in a multi-use facility.

As new drug targets naturally become more potent in the search for more effective therapeutics, there is a growing demand for capacity and capabilities in support. The development and manufacture of Highly Potent Active Pharmaceutical Ingredients (HPAPI) in a multi-use facility faces challenges of technical, procedural and a perception-based nature. Fundamentally, it all starts with the use of the right tool for the job.

Topics: Webinars HPAPI Manufacturing HPAPI CDMO API

Join us in Cambridge, MA on Thursday, October 19th!

Join us for a networking happy hour event in the heart of Kendall Square, from 5:00 - 8:00 pm on Thursday, October 19th!

Connect with Alcami team members and other industry peers over a selection of complimentary craft beer and light appetizers at Meadhall, located in Cambridge, MA.

 


Topics: Events