Collaborating with some of the world’s largest pharmaceutical and consumer product companies, as well as with start-ups seeking to get to the next level, we offer a full range of contract development and manufacturing solutions for companies of all sizes. We have a proven track record of taking products from concept to development, through scale-up, and to commercial manufacture, with a focus on partner satisfaction.
|Crest® Whitestrips||Teeth Whitening|
|Twirla® (ethinyl estradiol and levonorgestrel)||Women’s Health|
The safety and efficacy of the products under investigation have not been established. There is no assurance that any of these investigational products will receive health authority approval or become commercially available in any country.
We have an industry-leading approach to both process and product development, leveraging a talented internal team with a depth of expertise in market-leading transdermal therapeutics. We closely coordinate with our partners to align our development efforts and to ensure a smooth and streamlined transition from product concept, to initial development, through scale-up, and to final commercial manufacture. Our approach to process and product development distinguishes us from other transdermal companies and frequently results in faster timelines and economic efficiencies.
Our proprietary and partnered products combine our state-of-the-art transdermal technologies with our extensive expertise in polymer blending, formulation, and process engineering. This enables Corium to develop novel transdermal solutions that can efficiently deliver both small molecules and biologics across the skin. Furthermore, our robust patent estate provides long-term competitive advantages and substantial life cycle management value.
Our commercial manufacturing operations facility is located in Grand Rapids, Michigan, encompassing more than 200,000 square feet of space, including compounding, conversion, and packaging equipment that has the capacity to manufacture well over 100 million patches annually.
Our Good Manufacturing Practice facilities are FDA and DEA registered, ISO9001 and ISO13485 certified, and are licensed to handle scheduled drugs and compounds requiring hazardous material handling. We are qualified for the manufacture of over-the-counter (OTC), medical device, and prescription transdermal, dermal, mucosal, and wound care products.
In addition to the batch compounding and continuous solvent cast technologies that are necessary for the manufacturing of many types of transdermal, dermal, and mucosal products, Corium is one of very few companies to use extrusion technology for the manufacture of these products. This extrusion technology enables greater formulation flexibility to achieve optimal drug delivery and results in lower product costs by avoiding solvents and requiring less cycle time and labor due to the single-step, continuous nature of the process.
Corium has manufactured hundreds of millions of transdermal patches over the years and has expertise in all stages and types of transdermal, dermal, and mucosal manufacturing, including
- Process development and scale-up
- Prototype, pilot, and commercial manufacturing
- Primary, secondary, and tertiary packaging
- Liquid compounding using hazardous solvents and Active Pharmaceutical Ingredients (APIs)
- Twin screw extrusion and mixer-extrusion capabilities
- High-speed, high-accuracy die cutting and customization (including integrated die cutting and pouching)
- Analytical method development, validation, and quality control with physical testing and analytical method capabilities
- Regulatory pathways for transdermal products, with focused expertise in CMC (chemistry, manufacturing, and controls) elements