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SCIENTIST SPOTLIGHT: February 2018

Name: Vishal Rana
Alcami Site: Edison, NJ

How long have you been with Alcami?

I have been with Alcami for five years.

What is your role? 
I am a Senior Chemistry Analyst / Lab Coordinator at the Edison, NJ site. My day-to-day activities include working on HPLC, GC, and Wet Chem projects, as well as assigning projects to analysts.

What is the most rewarding part of your job?
The most rewarding part of my job is being part of a team which provides direct or indirect support to the development and commercial release of drug products. It’s a great feeling knowing your contributions help treat a variety of diseases, assist those in pain, and potentially save millions of lives.

Topics: Blogs

Serialization CDMO Checklist

Given that serialization execution is new to many in the industry, what should drug developers look for when reviewing a new contract development and manufacturing organization (CDMO) that will be manufacturing serialized product or when approaching the project with existing CDMOs?

Topics: Regulatory Compliance Serialization Editorials

ON-DEMAND WEBINAR: Elemental Impurities - Missed the Deadline? Now What?

Join Alcami for a webinar to learn more about elemental impurities and the updated regulatory requirements.

It’s official! The methods outlined in USP General Chapter <231> are retired. If you missed the January 1, 2018 deadline, we are here to help. Our in-house experts will share our approved testing plan that can be submitted to the FDA to help ensure you are moving to compliance, and will highlight experiences gained while working with the new regulations.

Topics: Regulatory Compliance Webinars Elemental Impurities

Editorial: Stability Testing Ensures Proper Packaging for Drug Storage

Alcami recently contributed to an article featured in BioPharm International titled "Stability Testing Ensures Proper Packaging for Drug Storage." 

Stability testing is essential for maintaining the integrity and quality of biopharmaceuticals and for assessing an accurate shelf-life. It is an important aspect of quality control and is an important step in evaluating product safety and efficacy. It is also important for examining how critical quality attributes (CQAs) of a drug substance vary with time under different environmental factors.

Topics: Stability Editorials