Engagement Phases

Integra Continuous Manufacturing Systems (Integra CMS) is the leading provider of comprehensive scientific and technical support to manufacturers who seek to formulate, implement, or optimize continuously manufactured products. Our top network of global universities, industrial partners, and technology suppliers are here to deliver tailored, effective continuous manufacturing solutions with the following service models:

  • Strategic Consulting

    Often the most critical component of success is the strategy. Our team is available to support your team with independent, transparent product and equipment selection support, as well as development of continuous manufacturing strategies from concept to commercialization.

  • Technical Consulting

    Our team offers technical consulting for continuous process development, including material/equipment characterization, process modeling and integration, process analytical technologies (PAT) implementation, process monitoring, and verification for new, existing or soon to be transferred processes.

  • Regulatory Support

    We provide regulatory support for new and existing manufacturing processes from start to finish. Our team helps with filing, application and approval support, with foresight into what the regulators will be looking for and the questions they may ask along the way.

  • Evaluation &
    Training Services

    Whether you are in concept phase or already operating continuous processes, our team is available to review processes, identify gaps, present solutions, and provide relatable training to your teams. Training programs can be tailored to meet unique needs.

Using our Flexible Engagement Model, we can help you at any stage of your journey.

We work with you to apply our unique 12-step approach to craft the right process and product development model, focusing on enhancements needed in strategy, process analytics, process understanding, process control, and quality assurance.

It all starts with defining your correct engagement phase:

  • Conceptual Phase (Step 1)

    Your company has little prior experience in CM. How do you get started?

    We can help you identify proper objectives and craft the correct strategy, assess feasibility of CM processes for a new product, or apply CM to an existing product portfolio, including reviewing what resources and products/equipment options are needed to achieve your objectives.

    We use iterative questionnaires, interviews, and site visits to gain a clear understanding of customer strategic and technical goals; we then craft customized implementation plans that maximize value of CM to the customer.

  • Design and Mechanical Implementation Phase (Steps 2 through 6)

    You have identified a product. You seek to implement a continuous process to make it. It may either be in formulation and approval phase or could already be successfully made via traditional batch methods. We focus on optimizing your formulation; selecting, specifying and characterizing equipment, including individual unit operations and mechanically integrated equipment lines; and designing studies to generate the information needed to demonstrate process understanding. Integra CMS provides these services with the specific needs of a future regulatory filing in mind.

  • Quality Systems Integration Phase (Steps 6 through 11)

    You have selected, and perhaps implemented, the equipment intended to continuously manufacture your product, but you need help to meet evolving regulatory expectations on monitoring and controlling process performance and product quality. Integra CMS supports modeling and data analytics approaches to select, develop, and implement multivariate PAT methods and closed-loop process control approaches to monitor and assure performance and quality.

  • Optimization Phase (Step 12)

    You have implemented a continuous manufacturing process, and selected and implemented PAT methodologies, and you are now looking to optimize run-time performance, or to adapt the line to manufacture a different product. Our unmatched expertise and our toolbox can be applied to the development of advanced feed-forward, feed-back, and model-predictive control methodologies to enable the efficient application of sensors and controls to maximize performance, yield, productivity, and quality.