Advanced Medicine Partners CEO Andrew Knudten’s Editorial Published in Endpoints News

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.

If you want to learn more about our company’s deep experience and industry-leading expertise, reach out to us partnership@ampgtx.com.

How We Stand Apart to Deliver the Science, Partnership and Technical Solutions You Need

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).

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 partnership@ampgtx.com to learn more!