Alcami

Alcami is a US-based contract development, testing, and manufacturing organization for pharma and biotech companies. Since 1979, we support our clients in making their projects go from potential to reality day-after-day. Core Capabilities: - Sterile fill-finish development and manufacturing - Oral solid dose development and manufacturing - Laboratory development & testing services Our mission is to unlock the potential of transformative medicines for our customers. Specialties: Sterile Fill-Finish Development & Manufacturing, Oral Solid Dose Development & Manufacturing, Laboratory Services, Environmental Monitoring, Packaging & Labeling, Analytical Testing, Development Testing, Cleanroom Services, Chemistry, Microbiology, Stability, Formulation Development, Analytical Development, Full-Time Equivalent (FTE) Programs, Food Studies, ICP-MS Capabilities, Extractables & Leachables, Rapid Sterility, Companion Animal Health, Abuse-Deterrence Testing, and Biologics Analytical Development

Alcami Partners with Civica Rx in Multi-Year Agreement

Wilmington, N.C. – May 3, 2022 – Alcami, a leading United States-based contract development and manufacturing organization (CDMO), announced today that it is partnering with Civica Inc. (Civica Rx), a nonprofit pharmaceutical company focused on ensuring quality generic medicines are accessible and affordable to everyone. With the execution of this agreement, Alcami will provide analytical support for products to be manufactured at Civica’s 140,000 square-foot sterile injectable manufacturing facility in Petersburg, Virginia.

Alcami Expands Biopharma Storage at Masy BioServices

New Facility Adds 160,000 ft² of cGMP Pallet Storage Space

Parenteral Market Trends

With today’s growing pipeline of biologics, namely complex oncology products often delivered...

Alcami Adds Additional Formulation Development Capabilities

Formulation Development Suite to Support Small and Large Molecule Programs

Morrisville, North...

Alcami Attending DCAT Week 2022

As a proud member of the Drug, Chemical & Associated Technologies Association, Alcami is pleased to...

Alcami Expands Biologics Footprint with Investment in Durham

$10 Million Investment Doubles Laboratory Footprint & Enhances Large Molecule and Cell & Gene...

Bioanalytical Testing Trends in 2022

An increasing number of clinical trial registrations, more R&D investment, growing demand for...

EMPQ Case Study: Carolina Components Group

Read this case study to learn how Alcami supported Carolina Components Group in the successful...

Alcami Announces the Acquisition of Masy BioServices

Acquisition to add 375,000 ft² of cGMP Biostorage and Pharma Support Services

Alcami to Provide Analytical Support Services for Novavax’ COVID-19 Vaccine Candidate

DURHAM, N.C. – November 16, 2021 – Alcami, a leading United States-based contract development and...

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...

Case Study: OSD Formulation Development

Client Profile

The client needed formulation development of an oral dosage form from scratch. They...

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

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

QbD Addresses API Supply in Orphan Drug Formulation

According to the Food and Drug Administration and the Orphan Drug Designation program, orphan...

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...

On-Demand Lab Open House

From standalone projects through full-service programs, our laboratories provide solutions to your...

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...

On Demand Webinar: Microbial In-Use Studies

Microbial in-use (admixture) studies are performed to evaluate the growth of low-level...

On Demand Webinar: Combination Products & The CDMO

You're invited to take part in a now on demand webinar. During this webinar, regulatory and quality...

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...

On Demand Webinar: Beyond Elemental Impurities - New Applications of ICP-MS

You're invited to attend our on demand virtual event. During this webinar, scientific experts will ...

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

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

Virtual Open House: New Sterile Fill-Finish Development & Manufacturing Facility

We're kicking off the opening of our new formulation and sterile fill-finish facility with a...

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...

Full-Time Equivalent Programs: Outsourcing Analytical Testing

Alcami’s end-to-end analytical testing platform supports clients’ programs through every stage of a

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

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

Alcami Expands Sterile Fill-Finish Capacity with TRIPHARM Acquisition

Transaction Advances Alcami’s Strategic Plan by Adding Scale in Attractive and Growing Parenteral...

CHEMISTRY ANALYST SPOTLIGHT: Katie Shupe

Name: Katie Shupe

Alcami Site: St. Louis, MO

What is your role?

I am a lead chemistry analyst. I...

Alcami Expanding Parenteral Operations in SC

Durham, NC (USA) – December 17, 2019 – Alcami Corporation, a leading provider of fully-integrated...

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