News & Events

Our resource center provides company news, thought leadership content, and upcoming virtual events.

Abuse-Deterrent Studies – An Interview with Angela Moore

As one of the key contributors to current abuse-deterrent studies being performed in the Alcami...

Stability Testing of Quality Attributes for Drug Products

The quality attributes that everyone strives for are safety, product efficacy and integrity,...

How to Run a Successful Clinical Study the First Time - Part One

When an innovative New England-based biotech company needed a fresh batch of Active Pharmaceutical...

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...

Serialization Overview: What’s Required for November 27, 2017 Deadline

New requirements under the Drug Supply Chain Security Act (DSCSA) have been set for manufacturers,...

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...