Topical Drug Product Manufacturing and Filling for Use in Clinical Phase I and II Trials
Dow Development Laboratories, LLC (DDL) is FDA-accredited in non-sterile topical drug product manufacturing, filling, release, packaging and labeling. Drug products, including gels, creams, ointments, solutions and suspensions that are intended for clinical use are manufactured and filled in our dedicated production suites under GMP (Good Manufacturing Practices). Batch sizes may range from 250 grams to 35 kilograms.
The drug product may be filled into:
- Tubes (laminate or aluminum)
- Glass or plastic vials or bottles
During our topical drug product manufacturing process, the selected primary packaging material is confirmed to be compatible with the active pharmaceutical ingredient (API) in the drug product in advance of GMP manufacture and filling.
Drug Product Release
Products are released as per quality standards with strict quality assurance oversight. Depending on the product, release testing may include:
- Assay for API and degradation products
- MET (USP<61> and <62>)
Certificates of Analysis are prepared and approved for each batch. GMP stability testing may also include AET (USP<51>), weight loss and package integrity.
Clinical Supply Packaging, Labeling and Distribution for Drug Product
Custom labels and kits are designed, and products are packaged, labeled and distributed, either domestically or internationally. As appropriate for the study, a random code may be generated. DDL labels products for projects ranging from small, open-label Phase I studies to large, double-blind, multi-national Phase III trials.
Contact Us About Topical Drug Product Manufacturing Services
For questions or inquiries as to how Dow Development Laboratories’ topical drug product manufacturing specialists can be of assistance to you, please contact us at firstname.lastname@example.org.