As the global leader in Combination Product Services (CPS), WuXi AppTec offers specialized programs for all types of combination products – providing manufacturers with the services they require in support of product development, regulatory submission and marketing claims.
Our recognized leadership in this area is built on a unique alignment of expertise, strong technical staff, and long history of testing and manufacturing services for devices, tissue products, biologics, and pharmaceuticals.
Combination products add a layer of complexity to the process of determining your regulatory path and study designs. Studies can involve altered dosing routes and dose-range studies, and sample preparation is oftentimes adapted in order to best characterize the combination product.
WuXi AppTec’s scientists are exceptionally strong in areas critical to combination products – including virology, biology and biomedical engineering expertise. And in our many years of experience we have provided comprehensive services in such diverse product areas as implants, cellular products, gene therapies, monoclonals, vaccines and anti-infectives.
Examples of Combination Products
- Dermal implants
- Devices coated/impregnated with therapeutic agent/antibiotic
- Drug-eluting stents
- Metered-dose inhalers
- Monoclonal antibodies combined with a therapeutic drug
- Orthopedic implants with growth factors
- Prefilled syringes, insulin injectors
- Skin substitutes with cellular components
- Surgical trays with instruments and lidocaine or alcohol swabs
- Transdermal patches
- Wound sponges