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
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The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product...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...