Beyond expectations.

Laboratory Services

Specialty Capabilities

Extractables & Leachables Testing

ICP-MS Capabilities

Nitrosamines Testing

Solid-State Characterization

Specialty Testing Capabilities for Advanced Drug Development and Validation

Facing a challenge? Bring it to the Alcami team! We’re equipped and experienced in a broad assortment of specialty capabilities to provide solutions to your drug development process and validation challenges.

Environmental Monitoring & Cleanroom

A successful environmental monitoring program begins with the appropriate qualification and certification activities — to the groundwork for routine testing. Our team is well-versed in the current industry and regulatory standards and can assist you with the state of control of manufacturing and testing environments.

Food Interaction

Alcami is equipped and ready to handle study design and execution of food studies — to support a variety of oral solid dosage forms, including tablets, capsules, and suspensions. Our subject matter experts have developed and executed studies using infant formula, yogurt, orange juice, apple sauce, smoothies, and a variety of other foods and drinks.

ICP-MS Capabilities

We offer multiple ICP-MS capabilities, such as catalyst control, assay determination, organometallic compounds, and cleaning verification methods — in addition to elemental impurities testing (raw material and product testing).

Extractables & Leachables

Our scientists have a thorough working knowledge of plastics, rubber, and elastomeric materials — compounds frequently found in pharmaceutical manufacturing, packaging, and delivery technologies. Equipped with a wide range of compliant qualified instrumentation and working under cGMP guidelines, we perform timely, efficient trace analysis necessary to support your applications.

Nitrosamines

The Alcami team has the experience, technology, and testing platform to assist at all stages of nitrosamine assessments. There are two phases to nitrosamine compliance: assessment and testing.

Abuse Deterrence

Alcami specializes in Category 1 syringeability studies, has full GMP traceability, and uses a team-based approach to effectively meet client deadlines. This is especially important as Category 1 strategies and results drive the in-vivo Category 2 and 3 studies required for the abuse-deterrent labeling of drug products.

Rapid Sterility

Rapid sterility is an alternative microbiological test method to the US Pharmacopeia (USP) <71>, Ph. Eur. 2.6.1, and JP 4.06 sterility tests — allowing for shorter incubation periods and faster results. Alcami utilizes the Milliflex® Rapid System for the rapid sterility test, which uses adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after five days.

Mycoplasma Testing By qPCR

Alcami Corporation provides advanced Mycoplasma testing using qPCR technology, offering rapid and sensitive detection of contamination in biological samples. This service ensures compliance with regulatory standards and supports the safe manufacturing of biopharmaceutical products.

Solid State Characterization

Alcami offers specialized solid state characterization services to optimize drug development. By employing advanced techniques, such as X-ray diffraction, calorimetry, and microscopy, they identify critical solid-state properties to enhance formulation, manufacturing, and product performance.

Summary

Alcami offers specialized laboratory services to address complex drug development challenges. Their expertise includes solid-state characterization, extractables and leachables, ICP-MS, nitrosamines, cell-based assays, in-use/admix studies, disinfectant efficacy, food interaction, abuse deterrence, rapid sterility, elemental impurities, mycoplasma testing, cell bank testing, and reference standard management. Additionally, Alcami provides environmental monitoring and cleanroom services to ensure product quality and safety.

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