Blog: 505(b)(2): What You Need to Know
In recent years 505(b)(2) approvals have experienced double-digit growth. Many companies are...
Editorial: Reducing Risk with Abuse-Deterrent Formulations
Increasing prevalence of drug misuse and abuse is driving a heightened and more stringent approach...
Alcami Bolsters Leadership Team with Quality & Regulatory Appointments
WILMINGTON, NC – May 21, 2020 – Alcami, a North Carolina-based contract development and...
Alcami Appoints EVP of Drug Product Operations and VP of Laboratory Operations
WILMINGTON, NC – MAY 18, 2020 – Alcami, a North Carolina-based contract development and...
Component Selection Equates to Successful Sterile Fill-Finish Manufacturing
As a contract manufacturer, Alcami provides experience in all aspects of the manufacturing process,...
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...