Blog: Agency-Accepted Testing and Filing Strategy for Elemental Impurities
The new elemental impurities regulations stress the importance of controlling all sources of ...
Case Study: Medicines Development for Global Health
In 2016, the not-for-profit Australian biopharmaceutical company Medicines Development for Global...
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...
Important Steps for 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
Blog: Formulating for Orphan Indication Drug Products
According to the US Orphan Drug Act of 1983, a rare disease is defined as a condition that affects...
Blog: Considerations for Abuse-Deterrent Category One Syringeability Studies
The use of opioid medications for pain management continues to increase, generating an inevitable...
The Role of FTE (FULL TIME EQUIVALENT) Programs
An FTE agreement is considered a comprehensive analytical service that allows pharmaceutical and...
News: Alcami Announces Donation to Wilmington, North Carolina Fire Department
Wilmington, NC (USA) – June 14, 2018 – Alcami Corporation, a leading provider of fully-integrated...
Alcami’s Extended Workbench Supports Commercial Supply of Flexion Therapeutics’s ZILRETTA® (triamcinolone acetonide extended-release injectable suspension)
Durham, NC (USA) – June 13, 2018 – Alcami Corporation, a leading provider of fully-integrated...
Case Study: Implementing Serialization
The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product...
Alcami to Become Industry Leading Platform CDMO Following Acquisition by Madison Dearborn Partners
Durham, NC (USA) – June 1, 2018 – Alcami Corporation (“Alcami” or the “Company”), a leading...
Beyond the Bench: A Century of Experience
The second edition of the Beyond the Bench series features three of
Elevate Product Stewardship and Exceed Your Sustainability Goals
At Alcami, the health of our workers is not taken lightly. Rooted in the foundation of The Alcami...
Case Study: Challenges and Solutions to Formulating an Orphan Drug
According to the Food and Drug Administration and the Orphan Drug Designation program, orphan...
Understanding Pharmaceutical Packaging
For oral solid dose (OSD) pharmaceuticals, decisions regarding the type of packaging used are...
News: Alcami Donation to Outfit TROSA Medical Department
Durham, NC (USA) – March 15, 2018 – Alcami Corporation, a leading provider of fully-integrated...
Listicle: Serialization CDMO Checklist
Given that serialization execution is new to many in the industry, what should drug developers look...
Blog: Stability’s Role in the Drug Formulation Process
From molecule discovery through product release to market, quality attributes are carefully...
Editorial: Analytical Testing - Contractors Take on the Challenge of Complex Molecules
Alcami contributed to a special feature in Drug Development and Delivery magazine titled ...
ON-DEMAND WEBINAR: Abuse-Deterrent Category One Testing: Syringeability Studies
As of July 2017, America’s opioid crisis has been declared a state of emergency. In order to help...