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2320 Scientific Park Drive, Wilmington, NC, 28405, US
Alcami is a US contract development and manufacturing organization with 45+ years of experience advancing pharmaceuticals and biologics from development to delivery. Alcami provides fully integrated lab services, drug product manufacturing, and cGMP pharma storage and support services including calibration, validation and environmental monitoring.
Precise storage conditions are critical to maintaining the quality and integrity of pharmaceutical products. Pharma storage must provide secure, cGMP-compliant solutions backed by advanced infrastructure, including redundant power and cooling systems, 24/7 monitoring, and multi-layered access control. A full spectrum of storage environments—from ambient, refrigerated, and ICH stability to ultra-low and cryogenic—are needed to meet […]
Released By Alcami Corporation
Timothy Compton of Alcami shares insight on Alcami's role in ensuring a smooth transition from development to manufacturing.
Gain insights into the parenteral and fill-finish manufacturing markets, opportunities, and recent investments in the space.
A $31 million investment will expand its sterile development and manufacturing operation in Charleston, SC.
Chad Bovero, James Fife, and Tobin Cowart promoted to senior leadership team.
Alcami to manufacture PharmaTher’s proprietary ketamine products for FDA Phase 3 clinical studies and global commercialization.
25-year industry professional brings a track record of leading high-performing, client-centered business teams.
Alcami used a Gerteis Mini-Pactor® roller compactor to develop a capsule formulation and critical processing parameters at the target dosage in record time.
WHO, FDA and the European Pharmacopoeia have established strict regulatory guidelines to guarantee product quality in biologics.
Due to the high costs and low demands of the drug product, it is important to efficiently use API supply during the formulation process.
In this webinar, Alcami’s Brent Harlow will guide you through the necessity of these studies and how to successfully perform them for FDA approval.
Sign up to get a close-up look at our US network of laboratories and hear about our expansion plans.
The agreement represents another step toward the proprietary manufacturing, formulation, and delivery of products for Tryp’s PFNTM program.
He succeeds Walter J. Kaczmarek III, who is stepping down as Chief Executive Officer.
Formulation and Method Development.
Parenteral Forms.
Wether you are a virtual start-up or a large organization, you and your patients deserve subject matter experts who take ownership of your program from clinical trals through commerical supply. Partnering with Alcami as your contract development and manufacturing organization connects you to a US-based team of dedicated professionals with over 40 years experience advancing […]
Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs)
Alcami, a leading United States-based contract development and manufacturing organization (CDMO), announced an additional $2 million investment to expand its oral solid development and manufacturing capabilities in Wilmington, NC. The investment will add a Gerteis Mini-Pactor® roller compactor and low humidity suites to Alcami’s existing 140,000 square foot campus in Wilmington, NC. The expansion, which is on track to be completed in the first […]
High-resolution mass spectrometry is a key component in the characterization of novel biologics and biosimilars.
Alternate methods of administering solid oral formulations are necessary to meet the needs of all patients.
by Chris Williams, Julia Spraul (pictured), and Alyssa McBurney
Codis launches as a global CDMO specializing in spray drying, amorphous solid dispersions, and particle engineering, uniting Particle Dynamics and EUROAPI’s former Haverhill facility under one brand.
Released By Codis
Sentry’s foreign trade zone expertise helps pharmaceutical companies mitigate risks from tariffs and global trade volatility.
Released By Sentry BioPharma Services, Inc.
AGC Biologics to provide GMP manufacturing for AAVantgarde’s two novel candidates designed to address progressive and irreversible vision loss.
By: Charlie Sternberg
Agreements will utilize ProFound's and Quotient's platform technologies to discover and validate novel treatments for respiratory and liver diseases.
A conversation with Upperton’s Director of Pharmaceutical Sciences
Released By Upperton
The collaboration will leverage AGC Biologics' mRNA manufacturing knowledge and expertise to combat a leading cause of human mortality.
Growth in the quarter driven by DARZALEX, CARVYKTI, ERLEADA in Oncology, TREMFYA and SIMPONI in Immunology, and SPRAVATO in Neuroscience.
By: Kristin Brooks
Marks a strategic milestone in Halozyme’s mission to expand its drug delivery technology offerings to biopharma companies.
This is the world’s first liquid formulation of IV infliximab and is available in 100 mg and 350 mg vials.
By: Rachel Klemovitch
Non-exclusive license provides Solid’s proprietary, next-gen capsid, AAV-SLB101, to Andelyn Biosciences.
Richard Pazdur to help guide CDER agenda to modernize the agency and streamline the approval process.
Carlos Martin joins the company with over 20 years of leadership experience.
A guide to the advantages and disadvantages of One-site vs Multi-site/Global CDMOs
Lessons Learned and Best Practices from a CDMO Perspective
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