Academia Tackles QbD Science: NIPTE Carries out FDA Grant and Educational Initiatives

A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry.
Oct 02, 2009

The National Institute for Pharmaceutical Technology and Education (NIPTE) was formed in June 2007 as an independent nonprofit organization by 11 major US universities. Approximately 30 faculty members from the member universities* are collaborating on various NIPTE projects, as are scientists from Pfizer (New York), Baxter (Bloomington, IN), Abbott Laboratories (Abbott Park, IL), and the US Food and Drug Administration. The institute s research agenda, aimed at improving the quality of drugs and pharmaceutical products, includes the following:

  • Developing an understanding of factors affecting variability in drug development, scale-up, quality, and manufacturing
  • Improving the scientific basis for understanding the behavior of pharmaceutical materials and the requisite processing steps
  • Developing tools to predict product performance early in the development process as well as strategies to allow rapid design and scale-up of manufacturing processes
  • Reducing risk and time-to-market for new drugs.

Fulfilling the FDA contract

The US Food and Drug Administration's Center for Drug Evaluation and Research granted NIPTE a $1.19-million contract in September 2008 to help carry out the institute s bold agenda. The funds are to be used to develop quality-by-design (QbD) science for pharmaceutical developers and manufacturers. "The agency plans to make available and use NIPTE s research to develop the science that is badly required for rapid, industrywide QbD implementation," says NIPTE Executive Director Prabir Basu.

NIPTE researchers are looking at, among other things, how to develop a complete manufacturing process using QbD. This process includes tools that can help develop design space and process analytical technology applications; methodologies for conducting risk analysis and scale-up; design space protocols for unit operations; bioreactor modeling; characterization of excipients (i.e., understanding and predicting their physical and functional properties); pediatric formulations; biotechnology product development; and prediction models for active pharmaceutical ingredient and formulation properties such as solubility, taste, and stability.

"We are making good progress in designing protocols for scaling up unit operations such as blending, granulation, and fluid-bed drying," says Basu. "We are also making good progress on developing a QbD case study for developing a parenteral freeze-dried dosage form for a small molecule."

Once the FDA grant period ends in September 2010, NIPTE plans to hold a public workshop about its findings. Although there's no guarantee that the institute's work will lead FDA to revise related guidances, the availability of better science could change some current thinking on the part of regulators, including at the International Conference on Harmonization, says Basu.

Educating for the future

A major component of the institute's work is educating the industry and scientific community. NIPTE is developing educational materials and training programs on QbD-based science and applications with the ultimate goal of creating an academic curriculum.

"Many scientists in the industry and at our regulatory agency do not have adequate training in the science required or have available all the tools required to implement QbD," explains Basu. "In addition, at our universities, the disciplines such as pharmacy, chemistry, and engineering work in silos. An industry senior vice-president once commented that they have to sometimes hire three people to do one person's job. NIPTE s intent is to take the best educational materials from the entire available curriculum from all the current bachelor and master of science programs in pharmacy and pharmaceutical engineering and develop an integrated curriculum for a pharmaceutical science and engineering program that all the NIPTE schools and beyond can use as a model program."

Currently, NIPTE operates out of Purdue University in Indiana, but the long-term goal is to have at least one Center of Excellence at each of the member institutions, says Basu. In addition to using a potential new curriculum, each center would specialize in at least one topic or area of research in pharmaceutical process development and manufacturing so that QbD science can continue to develop.

As for current industry professionals, some retraining in QbD science and processes will be a must, says Basu. NIPTE programs will be available to companies' internal educational programs and to other interested parties.