Blog: Successful Methods for Obtaining Orphan Drug Approval
Signed into law on January 4, 1983, the Orphan Drug Act (ODA) allows for granting special status to...
Alcami Supporting Potential COVID-19 Treatment
WOODCLIFF LAKE, N.J. —April 16, 2020— Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle”), a New...
Challenge Accepted! Problem-Solving Examples for Packaging Dilemmas
Even well-designed product formulations can fail if it is contained in inappropriate packaging. How...
Full-Time Equivalent Programs: Outsourcing Analytical Testing
Alcami’s end-to-end analytical testing platform supports clients’ programs through every stage of a
Benefits of Establishing a Full-Time Equivalent (FTE) Program
A Full-Time Equivalent (FTE) agreement is a comprehensive analytical service that grants...
Alcami Expands Sterile Fill-Finish Capacity with TRIPHARM Acquisition
Transaction Advances Alcami’s Strategic Plan by Adding Scale in Attractive and Growing Parenteral...
CHEMISTRY ANALYST SPOTLIGHT: Katie Shupe
Name: Katie Shupe
Alcami Site: St. Louis, MO
What is your role?
I am a lead chemistry analyst. I...
Alcami Expanding Parenteral Operations in SC
Durham, NC (USA) – December 17, 2019 – Alcami Corporation, a leading provider of fully-integrated...
LYOPHILIZATION SPOTLIGHT: Norman Chieng
Name: Norman Chieng, PhD
Alcami Site: Charleston, SC
What is your role? I am a senior scientist in...
Blog: The Importance of Secondary Packaging
There are three main types of packaging – primary, secondary, and tertiary – and it is important to...
Alcami Launches New Rapid Sterility Testing Services
Durham, NC (USA) – October 8, 2019 – Alcami Corporation, a leading provider of fully-integrated...
Blog: Regulatory Requirements for Early Phase Drug Product Development
Supporting a compound from discovery to clinical phases and potentially commercial phases requires...
Blog: Top Stability Testing Factors You Should Consider
Stability testing is a fundamental part of the drug development process— upholding the quality of...
The Top 8 Most Asked Questions about Microbial In-Use Studies
According to Dr. John Metcalfe, “pharmaceutical companies go to great lengths to manufacture a drug...
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...
Beyond the Label: Four Challenges to Serialization
Many pharmaceutical manufacturers are concerned about label design and placement to accommodate a...
Quota, Import, and Export Processes for DEA Controlled Substances
Controlled drug substances are scheduled based on medical use in treatment, potential for abuse,...
Alcami Helps Secure FDA Approval for MDGH
Durham, NC (USA) – October 25, 2018 – Alcami Corporation, a leading provider of fully-integrated...
SCIENTIST SPOTLIGHT: Steven Froelich
Name: Steven Froelich
ON-DEMAND WEBINAR: Extractables & Leachables
Requirements from regulatory agencies have become increasingly rigorous with regards to the...
News: Alcami and UNCW Awarded Biomanufacturing Workforce Development Grant
Project Call 1.0 Proposal Selected by NIIMBL Governing Committee