We bring innovations from idea to product
We have a full-service analytical capability that includes developing methods for product release and characterization. We offer robust and validatable product release methods, including bioassays, developed to ensure identity, safety, purity, and product potency. In addition we perform stability studies and formulation analysis.
We have a highly experienced and flexible team dedicated to our process development service offerings. With over 70 years of combined experience we have a rich history in successfully providing development services.
Our expert solid-state knowledge is multidimensional, facilitating a complete solid-state package for a successful project development as well as having a unique crystallization know how supported by state-of-the-art instruments.
We operate a full cGMP and ISO 13485 production site with five dedicated manufacturing suites extensive manufacturing experience. We offer supply at all scales from clinical to commercial.
Our manufacturing service in lyophilization can help overcome many of the stability challenges associated with complex, sensitive products, resulting in a longer shelf life for the product.
Our manufacturing teams are trained in small scale semi-automated vial filling and finishing. The line is flexible, accommodating either time-pressure filling or filling by peristaltic pump.
Our proprietary SMARTDRUG™ platform is composed of biologically safe microspheres. By combining these with active ingredients, a new, safe delivery method can be developed at significantly lower cost and risk.