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...
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...
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...
Alcami Launches New Rapid Sterility Testing Services
Durham, NC (USA) – October 8, 2019 – Alcami Corporation, a leading provider of fully-integrated...
Blog: Regulatory Requirements for Early Phase Drug Product Development
Supporting a compound from discovery to clinical phases and potentially commercial phases requires...