An editorial written by Andrew Knudten, CEO of Advanced Medicine Partners, focused on the importance of fully characterizing a manufacturing process to promote patient safety and advance gene therapies, was published by Endpoints News. Read the full piece here.
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At Advanced Medicine Partners, we have a very clear vision for our company – to be THE leader in process development, manufacturing, analytical development and testing for advanced therapy products. Our vision stems from our deep desire to improve the lives of patients and their families, and from our unrelenting drive to push the boundaries of science to create the purest and most potent medicines possible. To become THE leader, though, we have to clearly differentiate ourselves from traditional contract development manufacturing organizations (CDMOs). Having spent many years as clients ourselves, we identified three key areas that would set Advanced Medicine Partners apart from the rest: experience, past successes and a proven track record; depth and breadth of capabilities; and a true partnership mindset focused on accelerating programs, not slowing things down. We have been on the other side of the table, so we know how important these differences are.
We are fortunate at Advanced Medicine Partners to have one of the most experienced genetic medicines teams – at all levels, from bench to boardroom – in the industry. We boast 583 combined years of biopharma experience and 217 combined years of gene therapy CMC experience. While those numbers are impressive, it’s more important what our team accomplished in those years. For example, we have led CMC efforts for three globally approved gene therapies. Part of that work involved taking an academic manufacturing process and scaling it up for clinical and commercial needs, while working with regulators to ensure a robust CMC package and prove comparability between the academic and commercial process. We have also developed a best-in-class proprietary AAV manufacturing process that prioritizes patient safety by minimizing process and product related impurities while still maintaining industry-leading batch yields.
We’ve taken our experience and previous successes and built on them to be able to offer expansive development capabilities to partnering companies.
- Process Sciences: 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 AMBR modular bioreactor systems, to 200L and 500L commercial-scale bioreactors. With a wide array of equipment in varying scales, manufacturers and in-process testing capabilities, we can execute early-stage bench scale development work through commercial-scale IND-enabling material generation.
- Analytical Development: Advanced Medicine Partners has 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. Our platform methods are already qualified and readily available. Many of our assays are validated and available for GMP product testing and release.
- Quality and Regulatory Consultation: We offer a full suite of quality and regulatory consultation services. Our team has a deep understanding of successful CMC regulatory packages. We offer our partnering companies CMC strategy development, IND/IMPD CMC documentation preparation and agency support.
- GMP Manufacturing: Advanced Medicine Partners uses a commercially viable GMP-ready process to generate product for preclinical studies, product characterization, stability, and a host of other uses including material compatibility and other tests required by regulators. 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. We anticipate it to be fully operational supporting clinical GMP in early 2025.
When it comes to adeno-associated virus (AAV) work, we have developed a robust and reproducible manufacturing process that is commercially viable and highly productive, including best-in-class analytics and characterization. Our innovative AAV process is one of the most productive in the industry (see figure 1).
There’s no doubt that experience and past successes as well as current capabilities are critical, but we think our MOST important differentiator is our partnership mindset. Traditionally, CDMO operations work independent of their clients – we want to be your partner in the truest sense of the word. We want you to think of us as your extended workbench because we know real-time data helps you drive decisions and accelerate your programs. Our partnership philosophy is fully collaborative and amplifies the capabilities of our partners. By leveraging our collective knowledge and experience (your experience and Advanced Medicine Partners’ experience), we will build a long-lasting partnership that allow for delivering fast and effective solutions for patients.
We are so proud to have launched Advanced Medicine partners to set new standard in developing and manufacturing innovative medicines. From the start, we have had our partnered companies in mind and have built our entire operation to stand apart by delivering the science, partnership and technical solutions you need. Reach out to email@example.com to learn more!
- New company, spinning out from Jaguar Gene Therapy with funding led by Deerfield Management Company, created to provide best-in-class chemistry, manufacturing and controls (CMC) capabilities for advanced medicines, including gene and cell therapies, and address product quality and scalability issues facing many highly technical medicines
- Experienced management and technical team who directed CMC work for numerous commercially available therapeutics, including three globally approved gene therapies
- Operational infrastructure is in place today to support process and analytical development, quality control (QC) testing and full-scale Investigational New Drug Application (IND) enabling manufacturing – good manufacturing practice (GMP) suites are in progress for clinical and commercial manufacturing
- Company will continue to lead CMC efforts for Jaguar Gene Therapy’s pipeline programs
DURHAM, North Carolina – January 17, 2024 – Advanced Medicine Partners, an organization that delivers process development, manufacturing, analytical development and testing for advanced therapy products, today announced its launch from Jaguar Gene Therapy with funding led by Deerfield Management Company, with additional investors including ARCH Venture Partners, Nolan Capital and others. The newly independent company is helmed by a team of experts who were directly responsible for the CMC efforts for numerous commercially available therapeutics including three globally approved gene therapies. The organization will continue to lead CMC efforts for Jaguar Gene Therapy’s pipeline programs, will support CMC work for Deerfield academic projects and private portfolio companies, and has initiated work for several biotech and pharmaceutical clients.
“Advanced Medicine Partners is a science- and mission-driven organization made up of one of the most experienced genetic medicines teams in the industry, and we are driven to deliver products and services that aim to set a new standard in the manufacturing and testing of innovative therapies,” said Andrew Knudten, CEO of Advanced Medicine Partners. “With so many biotechnology companies being slowed or halted due to manufacturing challenges including product quality and scalability, we have the experienced people and technology to deliver what’s acutely needed right now – therapeutic product with purity and potency levels that exceed expectations of partnering companies and regulators, and that will potentially bring positive benefit to patients.”
Advanced Medicine Partners has a proprietary and proven development platform and has established a robust and reproducible adeno-associated virus (AAV) manufacturing process, which is among the most productive in the industry and consistently generates industry-leading functional full capsid ratios. Advanced Medicine Partners’ process has been used with multiple genes of interest as well as multiple wild-type AAV serotypes and engineered capsids. 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. The company has also developed a suite of platform analytical methods that can be licensed and offers assay development services.
Advanced Medicine Partners brings extensive operational experience from Jaguar Gene Therapy and other biotechnology companies, including AveXis, Novartis and Amgen. The Advanced Medicine Partners team has manufactured upwards of 350 total non-GMP batches and supplied over 20 preclinical studies, including IND-enabling efficacy and good laboratory practice (GLP) toxicology studies, as part of Jaguar. In addition to Advanced Medicine Partners’ manufacturing and analytical testing capabilities, the company offers GMP tech transfer capabilities and virtual CMC support.
Advanced Medicine Partners currently operates with more than 33,000 square feet of lab, office and warehouse space in Cary and Durham, North Carolina. The company is in the process of building out a 174,000-square-foot GMP manufacturing facility in Durham. Advanced Medicine Partners has the ability to build dedicated capacity for partnered companies in this new facility.
“We are very pleased to partner with the highly experienced team at Advanced Medicine Partners,” said Jonathan Leff, Partner at Deerfield Management Company. “With the demonstrated track record of the leadership team, the company brings much needed expertise and capability to the development and manufacturing of advanced products such as gene and cell therapies.”
ABOUT ADVANCED MEDICINE PARTNERS
Advanced Medicine Partners, LLC is driven to accelerate the development of innovative advanced medicines to enable partnering companies to make a positive difference for the patients they serve. With one of the most experienced genetic medicines teams – at all levels, from bench to boardroom – in the industry, the company uses its expertise to produce best-in-class advanced therapy products and analytics. Advanced Medicine Partners’ 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. For more information, please visit www.ampgtx.com and follow Advanced Medicine Partners on LinkedIn.
ABOUT JAGUAR GENE THERAPY
Jaguar Gene Therapy, LLC is dedicated to accelerating breakthroughs in gene therapy for patients suffering from severe genetic diseases including those that impact sizeable patient populations. The company is made up of a proven team of experts who have first-hand experience in bringing novel gene therapy treatments to patients and their families. Jaguar is rapidly advancing an initial pipeline of three programs. The company’s lead program, with a pending IND, targets severe neurodevelopmental disorders caused by mutations or deletions in SHANK3 including a genetic form of autism spectrum disorder and Phelan-McDermid syndrome. The second pipeline program targets Type 1 galactosemia and the third targets Type 1 diabetes. Jaguar partners with Advanced Medicine Partners, soon to be spun out from Jaguar, to produce its therapeutics. For more information, please visit www.jaguargenetherapy.com and follow Jaguar Gene Therapy on LinkedIn.