We leverage our deep experience to accelerate the development of advanced medicines, enabling partnered companies to improve the lives of patients.
Advanced Medicine Partners is the team that delivers. We use our expertise and experience to deliver best-in-class process development, manufacturing, analytical development and testing for advanced therapy products, specializing in viral vectors for gene and cell therapies. Our proprietary adeno-associated virus (AAV) manufacturing process minimizes impurities and consistently generates industry-leading functional full capsid ratios and process yields.
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.
Our Vision
We aspire to be the “CMC Gold Standard” for gene and cell therapies in the eyes of regulators, companies and investors. Our scientific and safety rigor will be the blueprint for all others to follow.
Our Values
We are grateful.
We are not entitled to anything in life and must earn the trust of our customers. We are humble in our approach, confident in our abilities and thankful for the opportunity to serve patients, partners and each other.
We are curious.
We assume positive intent and seek to understand. We listen with an open mind, learn and innovate.
We persevere.
We don’t just highlight problems. We are relentless in our pursuit of solutions to challenges with determination and tenacity unrivaled in the service space.
Advanced Medicine Partners offers expansive development capabilities – from concept to commercial. We specialize in viral vector manufacturing for gene and cell therapies, with a platform that enriches for functional full capsids. 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 (including Ambr® 250 Modular 8 Bioreactor and Ambr 250 24 Bioreactor system), 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 employs multiple orthogonal analytical methods, strategically using them at appropriate stages of the manufacturing process, to fully characterize product and precisely identify functional full, partial, and empty capsids to provide partnered companies with a superior therapeutic product with maximum purity and potency.
We boast 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. We offer a suite of platform analytical methods designed and qualified with multiple functional potency assays. This is possible using our platform methods that are already qualified and readily available, including more than 50 internal, off-the-shelf methods and 19 external methods to accelerate product characterization and reduce timelines. 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 Q1 2025, and there are opportunities for dedicated clinical and/or commercial capacity for potential partners in our build plans.
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:
