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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

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...

Blog: Top Stability Testing Factors You Should Consider

Stability testing is a fundamental part of the drug development process— upholding the quality of...

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...

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 Secure FDA Approval for MDGH

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

SCIENTIST SPOTLIGHT: Steven Froelich

Name: Steven Froelich

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

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 FTE (FULL TIME EQUIVALENT) 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...