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We provide a broad range of clinical manufacturing capabilities including API particle size reduction, spray dried intermediates, final dosage forms, and packaging. If you are developing a first-in-human asset, we have a variety of phase-appropriate processes to rapidly advance your drug to the clinic.
Serán provides a full range of particle engineering and formulation services using spray drying. Development batches can be as small as 100 mg. GMP manufacturing batches range from 100 g up to 50 kg.
Serán provides capsules (enteric or IR), and tablets (from minitablets to large format caplets) and powder-in-bottle formulations. Our solid dosage forms are engineered for a wide range of formulation approaches such as overcoming solubility challenges and to enable extended-release.
For early discovery and toxicology studies, we utilize a variety of suspension and solution approaches to obtain desired in vivo exposure, especially at high doses. As you advance to the clinic, our solid dosage form approaches are designed to achieve your preferred performance and are engineered for scalability.
Serán has extensive solid-state analytical capabilities to assess physical/chemical forms of crystalline and amorphous API and drug product. We have a fully-equipped QC Lab to support GMP method development, release testing and stability assessment.
Our staff has decades of experience in drug development and understands the challenges and solutions that each project requires. Our regulatory and quality team will work with your team to develop phase-appropriate strategies for rapid advancement.