Alcami Corp - Company Profile
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Business Description
Alcami Corp (Alcami) provides an array of integrated services, including drug product manufacturing, lab services, and cGMP pharma storage and support services, such as environmental monitoring, calibration and validation.
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R&D Overview
Alcami's R&D initiatives are embedded within its CDMO model, providing comprehensive support from early-stage development through commercialization. The major R&D areas include analytical development and testing, method development, validation, stability studies, and specialized analytical approaches for biologics to ensure product quality and regulatory compliance. The formulation development focuses on complex new chemical entities (NCEs) and various dosage forms, such as oral solids and sterile parenterals, addressing challenges like low solubility, poor bioavailability, and high drug loads. Solid-state characterization is employed to identify and develop polymorphs, salts, cocrystals, and efficient crystallization processes for stable and manufacturable formulations. Process development involves designing manufacturing processes and scaling up from characterization to clinical and commercial production. The R&D function is integrated with manufacturing, facilitating seamless technology transfer, effective sterile fill-finish and oral solid dose production, and consistent delivery of high-quality drug substances and products for clients in the pharmaceutical and biotech industries. The R&D unit of Alcami is integrated within its CDMO model, with responsibilities including analytical development and testing, method development, validation, stability studies, formulation development, solid-state characterization, and process development.
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