Drug Product Manufacturing and Filling for Use in Clinical Phase I and II Trials
Dow Development Laboratories is an FDA-accredited drug product manufacturer. Drug products, including gels, creams, ointments, solutions and suspensions, that are intended for clinical use are manufactured and filled at DDL under GMPs (Good Manufacturing Practices), in dedicated GMP production suites. 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
The selected primary packaging material is confirmed to be compatible with the 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.