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Outsourcing Trends in the Development of Biologics

The development of biologic drugs continues to increase at a rapid pace. Growing numbers of...

PharmaTher Engages Alcami for Clinical and Commercial Manufacturing of Novel Ketamine Products

  • Leading U.S.-based CDMO to manufacture PharmaTher’s proprietary ketamine products for FDA Phase 3...

Alcami Announces Parenteral Operations Leadership Appointments

DURHAM, N.C. – October 12, 2021 - Alcami, a leading United States-based contract development and...

Alcami Expands Parenteral Operations with Additional Investment

CHARLESTON, S.C. – September 29, 2021 - Alcami, a leading United States-based contract development...

Alcami Appoints Timothy Compton as Chief Business Officer

25-year industry professional brings a track record of leading high-performing, client-centered...

Fill-Finish Development Challenges & Solutions for CDMOs

Recently, contract development and manufacturing organizations (CDMOs) involved in the...

White Paper: Host Cell Impurities, Bioassays, Micro-Flow Imaging

As opposed to traditional drug production, the production of biological products (biologics)...

Tryp Therapeutics Partners with Alcami for Proprietary Formulations

The agreement represents another step toward the proprietary manufacturing, formulation, and...

EDITORIAL: Combination Products and their Regulatory Pathway

Combination products are becoming increasingly important to pharmaceutical CDMOs like Alcami, said...

Wilmington Business Journal Spotlight: Pharmaceutical Pipeline

Alcami is proud to call Wilmington, North Carolina their headquarters. In this spotlight, Alcami...

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

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

Outsourcing Analytical Testing- Innovative Drugs Spike Demand for Advanced Analysis

The global pharmaceutical analytical testing outsourcing market was estimated at $6.1 billion in...

Alcami Adds Gerteis and Low Humidity Suites to Wilmington, NC

Alcami, a leading United States-based contract development and manufacturing organization...

Alcami Voices: Risk Mitigation in the CDMO Space

Although there is no such thing as a truly “crisis-proof” organization, how are you working to...

White Paper: Leveraging Inductively Coupled Plasma Mass Spectrometry To Its Full Potential

Today’s technology has not only changed the way we receive information, but has continually adapted...

Editorial: Prepping Fill/Finish Systems to Ensure Quality Output

A holistic approach to validation and quality assurance is essential.

Biologic drugs are highly...

Alcami Continues to Execute Strategic Plan to Focus Its Platform with Sterling Pharma Solutions’ Acquisition

Global contract development and manufacturing organisation (CDMO), Sterling Pharma...

Blog: Food Interaction Studies 101

Alcami’s scientists have substantial experience designing and executing food interaction studies...

Alcami RTP Expansion Nears Completion

MORRISVILLE, N.C., July 28, 2020 -- Alcami, a US-based contract development and manufacturing...

Blog: 505(b)(2): What You Need to Know

In recent years 505(b)(2) approvals have experienced double-digit growth. Many companies are...

Roundtable Discussion: Greatest Drug Molecules to Impact Society

Q: What two or three drug molecules do you identify as having had the greatest impact on society?...

Editorial: Reducing Risk with Abuse-Deterrent Formulations

Increasing prevalence of drug misuse and abuse is driving a heightened and more stringent approach...

Alcami Bolsters Leadership Team with Quality & Regulatory Appointments

WILMINGTON, NC – May 21, 2020 – Alcami, a North Carolina-based contract development and...

Alcami Appoints EVP of Drug Product Operations and VP of Laboratory Operations

WILMINGTON, NC – MAY 18, 2020 – Alcami, a North Carolina-based contract development and...

Component Selection Equates to Successful Sterile Fill-Finish Manufacturing

As a contract manufacturer, Alcami provides experience in all aspects of the manufacturing process,...

Blog: Successful Methods for Obtaining Orphan Drug Approval

Signed into law on January 4, 1983, the Orphan Drug Act (ODA) allows for granting special status to...

Alcami Supporting Potential COVID-19 Treatment

WOODCLIFF LAKE, N.J. —April 16, 2020— Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle”), a New...

Challenge Accepted! Problem-Solving Examples for Packaging Dilemmas

Even well-designed product formulations can fail if it is contained in inappropriate packaging. How...

Benefits of Establishing a Full-Time Equivalent (FTE) Program

A Full-Time Equivalent (FTE) agreement is a comprehensive analytical service that grants...

CHEMISTRY ANALYST SPOTLIGHT: Katie Shupe

Name: Katie Shupe

Alcami Site: St. Louis, MO

What is your role?

I am a lead chemistry analyst. I...

LYOPHILIZATION SPOTLIGHT: Norman Chieng

Name: Norman Chieng, PhD

Alcami Site: Charleston, SC 

What is your role? I am a senior scientist in...

Blog: The Importance of Secondary Packaging

There are three main types of packaging – primary, secondary, and tertiary – and it is important to...

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...

Quota, Import, and Export Processes for DEA Controlled Substances

Controlled drug substances are scheduled based on medical use in treatment, potential for abuse,...

SCIENTIST SPOTLIGHT: Steven Froelich

Name: Steven Froelich

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...