Case story - Contura International

Since 1999, Chempilots has been closely involved in establishing production technology and contributing to new product development for Contura International. Contura is an innovative company that develops and markets injectable implants for various clinical applications.

Technology review and transfer
Chempilots was asked to review an acquired process for the production of a cross-linked polyacrylamide hydrogel used for subcutaneous augmentation. Our contributions included:

• Clarification and challenging of processing conditions by conducting a series of laboratory experiments
• Pilot production at our facilities to demonstrate new processing specifications and verify product characteristics
• Transfer of production specifications to the customer’s production
• Post-production processing studies and implementation of recommended improvements, which resulted in new efficient controls and improved yields

Product development
Through integrated process/product development, we identified new injectable hydrogel versions. These were optimized with regard to new clinical indications with specific injection techniques. Samples of hydrogels and injection prototypes were prepared and tested in vitro in our lab and selected for further development.

Products were prepared in our clean rooms under QA protocols. Together with clinicians, we participated in in vivo tests on pigs in order to identify appropriate clinical bulking procedures.

We contributed to the development of three new products marketed under the brands Aquamid®, Aquamid®-Reconstruction, and Bulkamid®. A fourth new product is in the pipeline.

Processing R&D
Based on laboratory research, Chempilots further detailed and invented processing steps in the production of cross-linked polyacrylamide. Patents are in effect worldwide.

New processing research and prototyping resulted in the invention of a new method for in line cross-linking (ILX™) of polyacrylamide as a highly controlable and continuous process. A patent was applied for and granted. Some basic elements of the ILX™-concept were implemented as improvements in the ongoing batch production.

Based on four years of production experience and the ILX™-concept, we further prototyped a new automated line for the production of hydrogel. A full size line was further engineered and fabrication is in progress.

Partnering
Contura has appointed Chempilots as their prime chemistry advisor and R&D partner.

We contribute with IPR, provide chemical-technical documentation for regulatory purposes, and challenge the production technology in order to establish better controls and a platform for innovative new products and processes.