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The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product...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...
Abuse-Deterrent Studies – An Interview with Angela Moore
As one of the key contributors to current abuse-deterrent studies being performed in the Alcami...
Blog: The Impact of Stability Studies on APIs and Drug Products
Can you answer any of these questions?
Stability Testing of Quality Attributes for Drug Products
The quality attributes that everyone strives for are safety, product efficacy and integrity,...
Part Two: Cell-Based Bioassays
Part Two: Cell-Based Bioassays
Part One: Biologics and the Problem with Residual DNA
Part One: Biologics and the Problem with Residual DNA
Video: Charleston Regional Development Alliance Features Alcami
Alcami's Charleston, South Carolina site is featured in a video produced by the Charleston Regional...
Editorial: Oral Solid Dosage Manufacturing Roundtable
Alcami contributed to a roundtable featured in Pharmaceutical Outsourcing magazine titled "Oral...
Alcami Awarded for 2016 Manufacturing and Laboratories Operations Performance
Alcami was awarded by the North Carolina Department of Labor for our 2016 manufacturing and...
In-Use Stability Testing: Providing the Right Instructions
In the WHO Technical Report Series, No. 953, 2009 Annex 2 Stability Testing of Active...
Serialization - Data Management Challenges
The implementation of the Drug Supply Chain Security Act (DSCSA) requirements poses many...
What are Extractables and Leachables?
Regulatory agencies have become increasingly rigorous with regards to the detection, identification...
Execution and Reporting of a Photostability Study Protocol
The protocol design, execution, and reporting of the confirmatory photostability for API and...
Alcami Announces Extended Workbench Offering for Analytical Services
Alcami, a leading provider of custom development and manufacturing services for the pharmaceutical...
Bringing the Light to Photostability in Three Parts
Part 1: Basic Requirements – Setting the Stage