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
The company’s R&D is embedded within its CDMO model, providing end-to-end support from early-stage development through commercialization. Its 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. Its formulation development focuses on complex new chemical entities (NCEs) and a range of dosage forms, such as oral solids and sterile parenterals. It effectively resolves challenges including low solubility, poor bioavailability, and high drug loads. Through solid-state characterization, it identifies and develops polymorphs, salts, cocrystals, and efficient crystallization processes to create stable and manufacturable formulations. Furthermore, process development involves designing manufacturing processes and scaling up from characterization to clinical and commercial production. This R&D function is integrated with manufacturing, connecting development, scale-up, and commercial supply to promote 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.
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