We accelerate the development of innovative advanced medicines to enable partnering companies to make a positive difference for the patients they serve.
Advanced Medicine Partners is the team that delivers. We use our expertise and experience to produce best-in-class innovative medicines and analytics. Our exclusive manufacturing platform consistently produces yields that are among the highest in the industry and purity profiles that continue to push the boundaries of what’s possible.
At Advanced Medicine Partners, we hold ourselves to the highest standards because we were a client like you, and we know what it means to depend on a partner to deliver. Our team has contributed to the development of more than 30 commercially available therapeutics within biotechnology companies. Because of that experience, we know what results mean to you and to the patients we serve.
Advanced Medicine Partners offers expansive development capabilities – from concept to commercial. We pride ourselves on our team’s personal commitment to ensuring your project’s success, every step of the way.
We conduct both small- and large-scale development work and have completed experiments ranging in scale from small well plates to 2L and 5L benchtop bioreactors, to 200L and 500L commercial-scale bioreactors. With a wide array of equipment in varying scales, manufacturers and in-process testing capabilities (such as cell analytics, turbidity, pH, conductivity and UV absorbance), the team can execute early-stage bench scale development work through commercial-scale IND-enabling material generation.
Advanced Medicine Partners boasts state-of-the-art analytical laboratories and equipment, which are designed to provide accurate and reliable results that meet cGMP standards. Our facilities are equipped with advanced instrumentation and technology, allowing us to offer a wide range of services, including raw material and finished product testing, product characterization testing, stability testing, analytical development and method qualification validation. This is possible using our platform methods that are already qualified and readily available. Based on our experience, we know a high level of characterization early on leads to more robust filings.
Advanced Medicine Partners offers a full suite of quality and regulatory consultation services. Our team has experience leading the quality and regulatory efforts for three globally approved gene therapy products, giving us a deep understanding of successful CMC regulatory packages. We offer our clients CMC strategy development, IND/IMPD CMC documentation preparation and agency support.
Advanced Medicine Partners uses a commercially viable GMP-ready process to produce product for preclinical studies. We are in the process of building out a 174,000-square-foot cGMP manufacturing facility with the flexibility for clinical and commercial production across modalities. Our team has deep site start-up experience, having contributed to more than 20 greenfield projects from initiation through start-up and nearly 70 large manufacturing facility projects. We anticipate our facility to be fully operational supporting clinical GMP in 2025.
AAV Gene Therapies
Adeno-associated virus (AAV) is a proven and well-characterized delivery method for gene therapies. Advanced Medicine Partners has developed a robust and reproducible manufacturing process that is commercially viable and highly productive for AAVs, including best-in-class analytics and characterization. Our innovative AAV process is one of the most productive in the industry and consistently generates >95% functional full capsids.
Our team has been directly responsible for:
