ON-DEMAND WEBINAR: Elemental Impurities - Everything You Need to Know

The introduction of new guidelines relating to elemental impurities in pharmaceuticals from the International Conference on Harmonization (ICH), U.S. Food and Drug Administration (FDA) and United States Pharmacopeia (USP) has created new and complex challenges for the pharmaceutical industry. These challenges include replacing the wet chemistry “heavy metals” limit test with new analytical technology, specifically, inductively coupled plasma (ICP) –based technologies and mandated conformance to new and specific limits for individual elements.  From a compliance perspective, the new guidance for elemental impurities (USP<232>and ICH Q3D) only applies to the drug product and the materials/processes involved.

Are you ready for this regulatory change?

Topics: Webinars Elemental Impurities

ON-DEMAND WEBINAR: Critical Drug Substance Considerations for Formulation Success in Drug Product Development

Join Alcami for a webinar discussing critical drug substance considerations for formulation success in drug product development.

Understanding the solid state properties of a drug candidate molecule is of critical importance for successful dosage form development. It takes close collaboration and communication between solid state characterization scientists, synthetic process chemists, analysts and engineers, and formulation development personnel to reduce risk, both in time and cost. 

Topics: Webinars

Editorial: Alcami Featured in Pharma Horizon's January 2017 Issue

Syed Husain, Alcami CCO is featured in an article published in Pharma Horizon's January 2017 issue. The article, written by Cynthia Challener, Scientific Content Director at That's Nice, LLC discusses next-generation therapies: overcoming bioprocessing, characterization and logistics challenges. 

Topics: Thought Leadership Manufacturing Editorials

Alcami Introduces Seamless Customer Experience with New Customer Portal and Application, Alcami OnDemand™

  • Unprecedented access, transparency and visualization of projects
  • Easy to use platform for submitting samples for analytical testing and checking project status
  • Provides a single source for order and project management with customer access to historical submissions and reports

Wilmington, NC (USA) – March 22, 2017 – Alcami, a leading provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, is setting the industry standard for project management and transparency with its new Customer Portal and Mobile Application: Alcami OnDemand™. The initial phase will concentrate on the sample submission process within its Analytical Testing offering.

Topics: Company News


Elsie Melsopp, Ph.D.
Alcami Site: Wilmington, NC

How long have you been with Alcami?
I will be celebrating my 20 year anniversary on March 17, 2017.

What is your role?
I lead the solids formulation development group, which is part of development services at our Wilmington, NC site.

What is the most rewarding part of your job?
Sharing the success of our customers and contributing to the pharmaceutical sciences.

Topics: Alcami Voices

Executive Q&A: Keys to Cultural Integration

As published in Pharma's Almanac Q1 2017.

Catherine Hanley, Alcami Director of Marketing, discusses with Nigel Walker of That's Nice how to successfully integrate after a merger.

Why is cultural integration following a merger so important to the success of the newly formed entity?

The impact on employee morale and turnover can be painfully high during and after a merger, and repairing it can be nearly impossible. If cultural integration doesn't happen, companies see significant and costly consequences.


Topics: Thought Leadership

Editorial: Supporting the Pharma Industry Small Business Growth Engine

As published in Pharma's Almanac Q1 2017.

Small and medium-sized companies generate
greater than two-thirds of the clinical candidates
in the pharma and biotech industry drug pipeline.
They often, however, lack the knowledge and
resources required to take a new medicine from
the lab to the market and need support
from CDMOs that offer integrated, tailored,
customized solutions and personalized
technical support.

Topics: Thought Leadership Editorials

Alcami Attending DCAT Week '17

Alcami will be attending DCAT Week '17, to be held March 20-23, 2017 in New York, NY.

DCAT Week is the premier business development event for companies engaged in pharmaceutical development and manufacturing and related industries. It is organized and hosted by the Drug, Chemical & Associated Technologies Association (DCAT) to assist its member companies with their business development objectives. Held annually in March, the event’s unique model brings together members for high-level strategic meetings with key decision makers, timely educational programs and important networking opportunities.

Topics: Events

Alcami in Action: 2016 in Review

Alcami is proud to have an established Foundations Team comprised of cross-functional team members from every site in our company. Committed to strengthening partnerships within our local communities, the team assesses and makes decisions about community outreach activities, charitable and nonprofit opportunities, sponsorships, and memberships. The team’s overall mission is to determine how Alcami and its employees can best connect with the communities in which they live and work. Combining company resources with their own, the team supports charitable and community organizations that advance the health industry, as well as STEM, economic, environmental and other social initiatives that align with the company’s mission and values. In addition to direct financial contributions, employees seek to make a difference in each of the communities in which we do business through strong volunteer partnerships. We look forward to our continued involvement in our local communities in 2017, but first let's revisit some highlights from 2016:

Topics: Alcami in Action

Executive Brief: An Opioid Abuse-Deterrent Roadmap for the Pharmaceutical Industry

Since 1999, deaths from prescription opioids—drugs like oxycodone, hydrocodone, and methadone—have quadrupled, causing more than 165,000 deaths in the U.S. 

Topics: Resource Center Abuse-Deterrence