Toward Real-Time Release at Rutgers

The Continuous Manufacturing (CM) program at Rutgers University continues

By Emil W. Ciurczak, Contributing Editor

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Rutgers Engineering Center for Structured Organic Particulate Systems (C-SOPS center) in New Brunswick recently opened its doors to Pharmaceutical Manufacturing for a first-hand look at its CM research program. The result of a close collaboration with Janssen and a number of academic, public and private entities, according to Rutgers “C-SOPS brings together a cross-disciplinary team of engineers and scientists, as well as industry leaders, to improve the way pharmaceuticals, foods and agricultural products are manufactured. C-SOPS will focus on advancing the scientific foundation for the optimal design of SOPS with advanced functionality while developing the methodologies for their active control and manufacturing.”

The overall objective of the project is to develop how to use raw material properties, formulation composition and process parameters to predict the properties of intermediate blends and finished direct compression products made in the existing INSPIRE (RU-CM) line.

RENEWED FUNDING

In May 2015, Janssen Supply Chain announced it had expanded its collaboration with Rutgers and the School of Engineering with a $6 million funding arrangement to help create the future of advanced manufacturing support for the school’s Continuous Manufacturing Initiative. The funds from Janssen, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, will increase research and development efforts at Rutgers’ C-SOPS over the next several years. The center is helping transition several products to continuous manufacturing, including developing a specially designed manufacturing line at Janssen’s new facility in Puerto Rico.

“We are very pleased to broaden our collaboration with Janssen on this important project and look forward to expanding collaborations with other pharmaceutical companies globally,” said C-SOPS director Fernando J. Muzzio. “Continuous manufacturing represents the future of advanced pharmaceutical manufacturing and will produce significant improvements in efficiency, safety, cost and speed to market. Our center is now better positioned than ever to serve the scientific community, the pharmaceutical industry and the regulatory agencies.”

According to Janssen, Rutgers established the engineering research center nine years ago with funding from the National Science Foundation and a consortium of more than 40 companies within the pharmaceutical sector, and is the world’s largest academic-based research organization dedicated to modernizing pharmaceutical manufacturing of solid oral dose medications.

The funding from Janssen represents a significant expansion of an arrangement that began five years ago and that focuses on technical development of continuous processing, an emerging advanced pharmaceutical manufacturing method. Besides the investment from Janssen, Rutgers anticipates another $1 million from the U.S. government as part of an ongoing FDA initiative. Anticipated outcomes include:

In-depth knowledge of the effects of material properties on product performance for existing CDC line, and General methodology for developing “formulation space models” using the available CM (continuous manufacturing) line as a first scenario, but implemented in a manner to facilitate the extension of the methodology to other continuous manufacturing systems.

In other words, the Rutgers’ team is attempting to build an ab initio approach to continuous manufacturing and real-time release (RTR), replacing the current ad hoc (product-by-product) approach.

To accomplish this end, a series of technologies are used, both in the lab and online, to characterize the interactions of raw materials and intermediates and how these affect both the process and finished product behavior (Critical Quality Attributes). The studies are designed to both characterize materials and give tools to developers with which to use these data to speed their own designs.

One example of a lab-based instrument is simply a rotating, clear cylinder with sensors located below and a series of light sources at one end. The device then has a known amount of powder or granular material added and is rotated along its long axis at various speeds. The combination of visual observations and weight distribution allows the researchers to characterize the flow (or sticking/lack of flow) character of any material.

These data are combined with the results of the Powder Rheology device. This rheology is, in essence, the “viscosity” of powders and, when combined with the “flowability” results, gives a clearer picture to formulators as to what to expect in a process stream. It allows them to anticipate the need and level of slip/flow agents for a particular formulation, without spending days or weeks experimenting with actual runs. Some of the production steps where this information may be used are:

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