Driving Innovation in Advanced Therapy Medicinal Products (ATMPs)

The landscape of ATMPs is rapidly evolving, driven by the breakthrough development of the approved gene therapy and cell therapy products. These success stories underscore the vast potential of ATMPs, driven by technological advances and growing market demand. As a pioneer in this field, Progress has enabled numerous biopharmaceutical companies to seamlessly ATMP development and manufacturing goals.

Understanding ATMP Manufacturing Risks

Manufacturing ATMPs presents unique challenges and risks compared to traditional pharmaceuticals. With an increased risk of contamination and complex production processes, strict control strategies are essential. We specialize in developing and implementing contamination control strategies tailored to the specific needs of ATMP companies and health organizations, ensuring regulatory compliance and product integrity.

Addressing Challenges in ATMP Facilities

Inspections at ATMP manufacturing sites often reveal challenges related to facility design, process validation, and compliance with GMP standards. Our team has extensive experience setting up ATMP manufacturing facilities, from cleanroom design to operational readiness. We ensure compliance with regulatory requirements, including the updated Annex 1 guideline, the Contamination Control Strategy (CCS) and the EudraLex Volume 4 Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products.

Commissioning, Qualification, and Validation (CQV) for ATMPs

Ensuring the reliability and compliance of manufacturing processes for ATMPs requires careful attention to Commissioning, Qualification and Validation (CQV). Our CQV specialists collaborate closely with ATMP companies to establish and implement tailored CQV protocols. From commissioning equipment to qualifying critical systems and validating processes, we ensure that every aspect of ATMP manufacturing is in line with regulatory standards and industry best practice. Our initiative-taking approach anticipates challenges, minimizes downtime, and accelerates time to market, empowering clients to navigate the complex landscape of ATMP development with confidence.

Exploring Opportunities in ATMP Process Development

Strategic decision-making and process optimization are critical to maximizing the efficiency of ATMP production. Our CMC and MSAT team of consultants specialize in Lean Six Sigma thinking and (PRINCE2) project management, helping clients prioritize investments and streamline their operations. By focusing on process intensification and automation, we enable clients to increase throughput and reduce costs while maintaining the highest quality standards.

Quality Support for ATMPs

Maintaining exceptional quality standards is paramount in the development and manufacturing of ATMPs. Our dedicated quality support services are designed to ensure product efficacy, compliance, and patient safety throughout the ATMP lifecycle. We offer comprehensive quality support tailored to the unique needs of ATMP organizations. From designing and implementing robust electronic or paper-based Quality Management Systems (QMS) to providing ongoing Quality Assurance (QA) support, our experts ensure compliance with regulatory requirements and industry guidelines (e.g., ISPE GAMP 5).

Networking at the Annual Dutch ATMP Summit (DAS)

In addition to our consulting services, Progress proudly organizes the annual Dutch ATMP Summit (DAS) held every March. This event serves as a platform to share knowledge, discuss emerging trends and network with industry experts in ATMP manufacturing. Join us at this prestigious meeting to stay up to date on the latest advancements and forge valuable connections within the ATMP community.

Partnering for Successful ATMP Development and Delivery

As the ATMP landscape continues to evolve, Progress remains committed to providing strategic and operational support to our clients. By leveraging our industry experience and best practices, we guide organizations in streamlining production processes and accelerating market access. From dealing with regulatory challenges to optimizing manufacturing processes, we aim to mitigate the specific risks associated with ATMPs with our expertise and services (see table below).

Contact us to learn more about how we can support your ATMP journey.