Regulatory

Experience for Process Success

Regulators around the world are enthusiastic about continuous pharmaceutical processing, but no specific guidance exists. The US FDA has only communicated expectations of high-level continuous process understanding and a strong preference for advanced sensing and process control methodologies. Our team’s comprehensive understanding of regulatory processes and expectations is a fundamental differentiator of working with Integra CMS, and the key to enabling your process success.

Integra CMS team members have worked with FDA and industry, including supporting FDA through consultations and training programs. Via C-SOPS, we have also participated in multiple FDA-funded projects focusing on how to develop and implement continuous processes to achieve optimum performance.

  • A TRACK RECORD OF SUCCESS

    Our team aligned with Janssen to support the first FDA-approved conversion of Prezista from batch to continuous in April 2016; Eli Lilly and Vertex have used a similar approach to develop three additional FDA-approved continuously manufactured products. We have also actively collaborated—and continue to do so—with companies that have recently filed, or are preparing to file, NDA and post approval supplements involving continuous manufacturing technology.

  • INNOVATIVE GUIDANCE

    CSOPS has long collaborated with the US FDA, and was honored to receive a request from Dr. Janet Woodcock in May 2015 for our team to create a C-SOPS-prepared draft guidance for continuous manufacturing. This project was led and delivered in June 2016 by two of our team members (Dr. Hausner and Dr. Muzzio) and is currently under consideration by FDA.

  • GRANTS FOR INNOVATION

    Through C-SOPS, FDA has provided members of our team multiple grants, totaling more than $6.5 million, to develop guidance elements for continuous manufacturing processes. As part of this funding, our team was able to develop and implement hands-on training programs in continuous manufacturing for FDA inspectors, reviewers, and scientists.

  • CONTINUOUS COLLABORATION

    Our team’s passion is driven by active collaborations, including helping to launch the continuous manufacturing expert committee of the USP. Every day we are in continuous collaborative dialogue with industry representatives regarding the implementation and optimization of continuous manufacturing systems.

As the result of these interactions, we are in an excellent position to help our customers to meet regulatory expectations. Our 12-step methodology for design and implementation is rapidly becoming the standard development pathway, and its components are frequently cited by regulators around the world as components of proper process development methodology.

Integra CMS is available to apply this wealth of knowledge and experience to support your team at any stage of the development process.