We sat down with Michael to discuss Eckert & Ziegler’s contract manufacturing capabilities.
Find out how we help customers put into place efficient clinical and commercial production of their radiopharmaceutical compounds.
As a leader in the specialized radiopharmaceutical industry, Eckert & Ziegler also provides essential contract development and GMP compliant contract manufacturing services (CMO) that bridge the gap for biotech and pharma firms lacking in-house radiopharmaceutical production and handling capabilities. These services are crucial, especially given the stringent requirements of GMP and radiation protection standards in the radiopharmaceutical environment.
Good Manufacturing Practice (GMP)
GMP refers to a set of guidelines and regulations that ensure products, particularly in the pharmaceutical, food, and medical device industries, are consistently produced and controlled according to quality standards. GMP covers all aspects of production, from raw materials to employee hygiene, equipment, and the final product. Adherence to GMP helps prevent contamination, mix-ups, errors, and ensures that products are safe for use and meet their intended specifications.
In the world of nuclear medicine, many great companies develop promising compounds—such as specific peptides or antibodies for cancer diagnosis and treatment—but also face significant barriers in bringing these products to market due to the high costs, expansive know-how requirements and regulatory hurdles associated with radiopharmaceutical production. This is where Eckert & Ziegler steps in, offering its well-established infrastructure and expertise to produce radiopharmaceuticals on a contract basis. By leveraging their capabilities, companies can efficiently move from development to clinical and commercial production, supported by a comprehensive service portfolio including reliable isotope supply, synthesizer equipment, and quality control devices.
To gain deeper insights into Eckert & Ziegler’s CMO services, we sat down with Dr. Michael Pröhl, our Director of CMO Business.
Question: Michael, can you share a bit about your background and how you came to lead the CMO business at Eckert & Ziegler?
Michael Pröhl: Absolutely. My journey began with a PhD in Chemistry, after which I worked at the Central Clinic in Bad Berka. There, I had the opportunity to produce various radiopharmaceutical products directly for patients in compliance with GMP conditions. I joined Eckert & Ziegler in 2018 and since then held various roles including Radiochemist, Project Manager, Head of Qualification/Validation, and now, overseeing the entire CMO business. Alongside my professional work, I am also pursuing an MBA and am currently working on my master’s thesis.
Picture of Michael
Q: What are your main responsibilities in your current role?
MP: I focus on project acquisition and translating customer requirements into the available capacities at Eckert & Ziegler’s various locations. This involves aligning with local teams to create tailored proposals that accurately reflect customer needs. Some clients require development support, while others might need immediate implementation of their manufacturing and quality control processes. Throughout this process, we maintain constant communication with our clients. Additionally, I hold commercial responsibility for the overall CMO business segment of Eckert & Ziegler.
Q: Can you give us an overview of the types of projects Eckert & Ziegler supports?
MP: We work on a variety of projects, ranging from manual to semi-automated processes, from low to higher activities, from Alpha- to Beta-Emitters, from very short to long-live isotopes or from R&D level to perfectly developed processes. While we can’t disclose most of our clients due to confidentiality agreements, the demand for our services is increasing and involves a wide variety of radioisotopes. We cater to companies looking to outsource their manufacturing processes, whether they lack the necessary infrastructure and expertise or are large pharmaceutical companies seeking cost-effective production solutions.
Q: What specific areas of expertise does Eckert & Ziegler offer?
MP: We provide a full spectrum of CMO services, from project implementation via tech transfer to clinical and commercial production following regulatory approval. Our expertise also includes developing complex quality control methods and optimizing radiolabeling parameters. Eckert & Ziegler is addressing the full value chain which includes the supply of medical isotopes such as Y-90, Lu-177 or Ac-225 as well as equipment like hot cells and synthesizers. This extensive product portfolio enables us to provide tailored solutions that precisely address the unique needs of each project. Customers benefit through enhanced efficiency, robust solutions, and competitive pricing models.
Q: How do clients benefit from Eckert & Ziegler’s contributions?
MP: Clients gain immediate access to our state-of-the-art production facilities located in Germany, the USA, and soon China. This strategic distribution allows for efficient clinical or commercial production across different markets. Our facilities are designed to meet the common requirements of a typical labeling process, saving clients significant time and reducing lead times for new production facilities. Our established quality assurance systems, approved by various regulatory bodies, ensure compliance and the highest standards in clinical GMP production.
Our team’s diverse experience ensures that we can provide tailored solutions to meet the specific needs and challenges of each project.
Moreover, our experienced team brings a wealth of knowledge to each client’s project. We have a track record of more than 50 successful projects with external pharma and biotechnology companies across various sectors, including the development and clinical supply of Investigational Medicinal Products (IMPs) and Investigational New Drugs (INDs). Based on these achievements, we offer valuable insights and expertise that can significantly contribute to the success of customer endeavors. Our team’s diverse experience ensures that we can provide tailored solutions to meet the specific needs and challenges of each project.
Q: How does Eckert & Ziegler ensure timely delivery and effective project management?
MP: We have a range of experienced project managers dedicated to each client’s project, ensuring timely fulfillment and transparent communication. The team brings a wealth of industry knowledge to each assignment, enabling us to navigate complex challenges and deliver exceptional results. We are committed to maintaining open lines of communication, providing clients with regular updates and detailed progress reports.
Any issues are promptly addressed with full transparency to maintain project momentum and client satisfaction. We employ proactive problem-solving techniques and leverage our extensive network of resources to resolve challenges efficiently. By identifying potential risks early and implementing effective mitigation strategies, we ensure that projects stay on track. Additionally, our project managers work closely with clients to foster a collaborative environment that promotes trust and confidence. This client-centric approach allows us to adapt to changing requirements swiftly and deliver outcomes that exceed expectations.
Q: What are the prospects for future collaborations in the radiopharmaceutical industry?
MP: Eckert & Ziegler is committed to fostering sustainable and long-term partnerships. The more extensive the interaction with our clients, the more synergistic the benefits. For instance, acting as a CMO across multiple locations can positively impact project outcomes as a result of comparable infrastructure between the different Eckert & Ziegler sites. Additionally, transitioning from clinical to commercial scale is more seamless when using the same CMO. We aim to expand our contract manufacturing business further, as our ready-to-use facilities are well-received, and the feedback has been overwhelmingly positive.
Q: Thank you for your insights, Michael!
Our conversation with Michael highlights the critical role we at Eckert & Ziegler play in the radiopharmaceutical industry. By offering comprehensive CMO services, we empower biotech firms to overcome significant production barriers and bring their innovative therapies to market efficiently. We invite potential clients to explore collaboration opportunities with Eckert & Ziegler, leveraging our extensive expertise and state-of-the-art facilities to achieve their project goals. Partner with us to turn your visionary therapies into reality. Contact us today to discuss how we can help you succeed!
To see one of our state-of-the-art GMP suites in action, watch the video below and take a tour through our Berlin facility!
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