New Product Partnering

AMW offers comprehensive expertise in long-acting sustained release formulations. The core resourced technology is based on Hot Melt Extrusion (HME) with specifically designed methods and processes. Final formulations span across biodegradable implants with optimal drug release kinetics profiles.

Holding resourceful end-to-end expertise, AMW can operate from early discovery and formulation feasibility, through pre-clinical packages, clinical batch manufacturing up to commercial production/supply. Leveraging extensive, market-proven expertise, AMW operates along the full value-chain of pharmaceutical product deployment on a global scale, acting as “one stop shop” for partnered drug-device combination products in the biodegradable implants space.

The development process at AMW includes AI modulation and rapid prototyping for an accelerated discovery phase to identify the optimal formulation composition and for engineering the new biodegradable implant. The next phase involves R&D scale Hot Melt Extrusion designed to reflect the currently established GMP unit models for commercial supply. Alongside that phase, the analytical method development is triggered for proper in-vitro release testing among other key parameter evaluation to achieve design-freeze. The entire process is then transferred to AMW´s GMP unit in a seamless transition to enable scale-up after pre-clinic and streamlining for commercial manufacturing.

The AMW campus is located in Warngau, south of Munich, Germany. The entire value chain is integrated on site, from R&D to commercial supply on a global scale. There are currently two units: one dedicated to the development phase of drug-device combination products, the other fully GMP-certified, with class C and D clean rooms across 2000 m². Expansion is on track for a significant commercial manufacturing capacity increase, with a state-of-the-art new production unit of 6000 m².

From development to GMP manufacturing, AMW counts on extensive market-proven expertise, both from a quality and regulatory perspective. Maintaining the highest GMP standards, our teams dedicated to quality control and quality assurance guarantee that all analytical and documentation work complies with audit requirements. Our regulatory team is fully dedicated to planning, approval and launch activities across the different authorities, from Europe to South America and South East Asia, among others. This also covers the medical device framework, where AMW has a proven track record in generating the Notified Body dossiers for the device as well as the combination product and receiving and/or maintaining the necessary approvals.