Advanced Medicine Partners Durham, NC , USA

About Advanced Medicine Partners :

Advanced Medicine Partners’ aims to set a new standard for manufacturing and testing innovative medicines that can potentially transform the lives of patients and families. The company delivers process development, manufacturing, analytical development and testing for advanced therapy products, including gene therapies. The company has the experience and capabilities to work with multiple platforms and modalities, including adeno-associated virus (AAV), lentivirus, and other delivery systems. Ad...Advanced Medicine Partners leverages one of the most experienced genetic medicines teams – at all levels, from bench to boardroom – in the industry, and its exclusive manufacturing platform consistently produces yields that are among the highest in the industry and purity profiles that push the boundaries of what’s possible.

The company’s proprietary adeno-associated virus (AAV) manufacturing process minimizes process and product-related impurities and consistently generates industry-leading functional full capsid ratios and best-in-class yields. This manufacturing process prioritizes patient safety while reducing cost of goods and will strive to set the standard for what regulatory agencies expect and patients deserve.

Advanced Medicine Partners brings extensive operational experience from Jaguar Gene Therapy and other biotechnology companies. The Advanced Medicine Partners team has manufactured upwards of 350 total non-GMP batches and supplied over 20 preclinical studies, including initial new drug application (IND) enabling efficacy and good laboratory practice (GLP) toxicology studies.

The company distinguishes itself from CDMOs by its partnership philosophy. Traditionally, CDMO operations work independently of their clients. Advanced Medicine Partners changes that dynamic by acting as a client’s extended workbench, removing CMC activities from the critical path, and offering real-time data to help clients drive decisions and accelerate their programs. read more

Service Offerings:

• Process Science
• Drug Discovery
• Upstream and Downstream Process Development and Optimization
• Analytical Development
• Method Development
• Qualification and Validation
• Quality and Regulatory Consultation
• Clinical and GMP Manufacturing

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