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
Antibiotic Potency Testing: Diffusion (Cylinder-Plate) Method
Both the European Pharmacopoeia and the US Pharmacopeial Convention (USP) require testing of...
Elemental Impurities USP: The Risk-Based Approach
The U.S. Pharmacopeia (USP) intends to remove the existing wet chemistry heavy metals methods...
Overview and Performance of the Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics
Several agencies within the U.S. Federal government are focused on reducing the prescription drug...
Blog: The Effect of Abuse-Deterrent Formulations on Opioid Abuse
In 2011, the White House published “Epidemic: Responding to America's Prescription Drug Abuse...
Elemental Impurities: Updated Regulatory Requirements
In 2013, the International Conference on Harmonization (ICH) approved ICH Q3D, a Guideline for...
News: Enhanced Laboratory Services in Wilmington, NC Headquarters
Wilmington, NC – June 20, 2016 – Alcami, a leading provider of custom development and manufacturing...
News: Alcami Invests in MicroSEQ® Rapid Microbial Identification System to Expand its Service Capabilities
Wilmington, NC – May 12, 2016 – Alcami, a leading provider of custom development and manufacturing...