Resource Center

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

Alcami Appoints Patrick D. Walsh as Chairman and Chief Executive Officer

Wilmington, N.C. – March 18, 2021 – Alcami, a global pharmaceutical contract development and...

Editorial: Designing a CMC Strategy for Accelerated Development of Biotherapeutics

Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled...

Roundtable Discussion: Novel Therapies

Alcami recently contributed to a roundtable discussion in Pharma's Almanac magazine, answering the...

News: Alcami St. Louis Facility Issued European Medicines Agency Certification

Alcami’s St. Louis, Missouri Center of Excellence for advanced analytical testing was issued a...

White Paper: Structural Characterization of Biologics Using High-Resolution Mass Spectrometry

Biopharmaceutical products represent up to 20 percent of the total pharmaceutical market and are...

Understanding Biologics: Your Top 7 Questions Answered

The biologics market represents the leading edge of novel therapeutics and is the fastest growing...

Video: Extractables and Leachables

Over the years, the US Pharmacopeia (USP), International Harmonisation (ICH), Product Quality...

SCIENTIST SPOTLIGHT: Czarina Carino

Name: Czarina CarinoAlcami Site: Durham, NC

How long have you been with Alcami?It will be my 11th...

eBook: Elemental Impurities

The US Pharmacopeia (USP) retired the existing wet chemistry heavy metals methods outlined in USP...

ON-DEMAND WEBINAR: Early Phase Development of Biologics

By some estimates, the pre-approval cost of drug development is a staggering $2.5 billion per drug...

Editorial: Oral Solids Endure & Evolve

Alcami recently contributed to an article in Contract Pharma titled "Oral Solids Endure & Evolve."

Beyond the Bench: UNC Wilmington Classroom to cGMP Laboratories

Alcami and the University of North Carolina Wilmington (UNCW) have partnered on an academic program...

Blog: Staying Ahead of OSD Challenges

Throughout the development lifecycle of oral solid dosage (OSD) drug products, possible challenges...

SCIENTIST SPOTLIGHT: Marilyn Heidbrink

Name: Marilyn HeidbrinkAlcami Site: St. Louis, MO

How long have you been with Alcami?I joined the...

Editorial: Customizing Programs to Meet Accelerated Product Timelines

Alcami contributed to a special feature in Drug Development and Delivery magazine titled...

The Top 5 Most Asked Extractables & Leachables Questions Answered

Agency expectations are quickly evolving for the evaluation of drug product packaging and delivery...

Video: Alcami's Oral Solid Dose Manufacturing

Specialized to manufacture oral solid dose (OSD) forms, Alcami’s Wilmington, North Carolina site...

Blog: Agency-Accepted Testing and Filing Strategy for Elemental Impurities

The new elemental impurities regulations stress the importance of controlling all sources of ...

Case Study: Medicines Development for Global Health

In 2016, the not-for-profit Australian biopharmaceutical company Medicines Development for Global...

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...

Important Steps for 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 Medicines Development for Global Health Secure FDA Approval of Moxidectin for River Blindness

Durham, NC (USA) – October 25, 2018 – Alcami Corporation, a leading provider of fully-integrated...

SCIENTIST SPOTLIGHT: Steven Froelich

Name: Steven FroelichAlcami Site: Charleston, SC

How long have you been with Alcami?I have been...

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

SCIENTIST SPOTLIGHT: Kourtney Bergeron

Name: Kourtney Mendieta BergeronAlcami Site: Charleston, SC

How long have you been with Alcami?I...

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 Full Time Equivalent (FTE) 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...

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...

SCIENTIST SPOTLIGHT: Jack James

Name: Jack JamesAlcami Site: Wilmington, NC

How long have you been with Alcami?I have been with...

Beyond the Bench: A Century of Experience

The second edition of the Beyond the Bench series features three of Alcami’s longest tenured...

Elevate Product Stewardship and Exceed Your Sustainability Goals

At Alcami, the health and safety of our workers is not taken lightly. Rooted in the foundation...

Alcami St. Louis Facility to be Honored by Missouri House of Representatives and City of St. Louis

Durham, NC (USA) – May 3, 2018 – Alcami Corporation, a leading provider of fully-integrated...

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...

Stability: Back to the Basics - Part V

Part V: The Summation of Stability and Quality Attributes

In this five-part blog series, Alcami...

Editorial: Analytical Testing - Contractors Take on the Challenge of Complex Molecules

Alcami contributed to a special feature in Drug Development and Delivery magazine titled ...

Stability: Back to the Basics - Part IV

Part IV: Stability and the Importance of Storage Conditions

In this five-part blog series,...

SCIENTIST SPOTLIGHT: Colleen Guthrie

Name: Colleen GuthrieAlcami Site: St. Louis, MO

How long have you been with Alcami?

I have been...

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...

Stability: Back to the Basics - Part III

Part III: Measuring Shelf Life— Product Efficacy of API and Finished Drug Products

In this...

Abuse-Deterrent Studies – An Interview with Angela Moore

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

Alcami Wins Prestigious Business of the Year Award from St. Louis Mayor

On Friday, October 13, 2017, Alcami proudly accepted the Business of the Year award from St....

SCIENTIST SPOTLIGHT: Stephanie Jarman

Name: Stephanie JarmanAlcami Site: St. Louis, MO

How long have you been with Alcami?

I began...

Stability: Back to the Basics - Part II

Part II: The Impact of Stability on the Safety of API and Drug Products

In this five-part blog...

Stability: Back to the Basics - Part I

Part I: The Importance of Stability in the Evaluation of Quality Attributes of Pharmaceutical...

St. Louis, Missouri Laboratory in Cortex Innovation Community

Durham, NC – September 12, 2017Alcami Corporation, a leading provider of custom development...

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...

Framework to Biologics – Part Two

Part Two: Cell-Based Bioassays

In part one of this biologics series, leading Alcami experts...

Framework to Biologics – A Three Part Series

Part One: Biologics and the Problem with Residual DNA

In this three-part series, members of...

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...

Extractables and Leachables – Why?

Regulatory agencies have become increasingly rigorous with regards to the detection,...

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,...

Bringing the Light to Photostability in Three Parts - Part Two

Part II: Forced Degradation Studies to Support Photostability  

In Part One of this...

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

ICH Guidance Q1B was published in 1996 describing...

Antibiotic Potency Testing: The Methods - Part 2

Using the Turbidimetric Method

In part one of this blog series, we discussed Antibiotic Potency...

Antibiotic Potency Testing: The Methods – Part 1

Using the Diffusion (Cylinder-Plate) Method 

Both the European Pharmacopoeia and the US...

Elemental Impurities: 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: Alcami Announces 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...