Drug Product Development Of Poorly Soluble Compounds

Eurofins CDMO Alphora is an FDA & Health Canada-approved contract drug development and manufacturing organization based in Canada. They specialize in formulation development and manufacturing services for both simple and complex dosage forms, with a core strength in small molecule compounds, particularly those with challenging physicochemical properties. Their services encompass pre-formulation (solubility and absorption studies, salt and polymorph screening, physical characterization), formulation (analytical method development, bioavailability enhancements like micronization and spray drying), and scale-up & clinical manufacturing (highly potent APIs, granulation, encapsulation, clinical packaging). They have extensive experience in developing poorly soluble compounds, focusing on material characterization, analytical chemistry, and phase-appropriate strategy for complex formulations and high containment operations.

Eurofins CDMO Alphora emphasizes "quick-to-clinic operations" with state-of-the-art GMP clinical drug product manufacturing facilities designed for this purpose. They specialize in process transfer and scale-up strategies to ensure a seamless transition from development to later-stage manufacturing. With over two decades of experience, they provide integrated drug development and manufacturing, supporting programs from preclinical stages to commercialization. Their services include API & HPAPI drug substance development, solid-state R&D to reduce polymorphism risk and generate IP, and drug product development focusing on solubility and candidate ranking for bioavailability. They also offer expertise in biologics, including antibody-drug conjugate (ADC) development. Eurofins CDMO Alphora serves a diverse range of clients, from startups to pharmaceutical companies, offering individualized, flexible, and high-quality services with strong quality and project management systems. They prioritize client satisfaction by delivering tailored solutions and have experience filing in over 25 countries.