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Center for Pharmaceutical Development (CPD)

Center Overview

The Center for Pharmaceutical Development (CPD) focuses on novel approaches to the final three stages of new drug development: active pharmaceutical ingredients manufacturing; drug product formulation; and analytical methods. CPD's mission is to create more selective and robust biological and chemical catalysts; develop methods for stabilizing drugs and vaccines; and design new techniques for nondestructive evaluation of pharmaceutical products.

CPD researches the creation of robust biological and chemical catalysts with better selectivity that will allow for more streamlined processes (manufacturing); the development of improved methods for stabilizing pharmaceuticals to protect the nation's drug supply (formulation); and the design of new analytical techniques for the nondestructive, accurate, and rapid evaluation of pharmaceutical products.

Universities

University of Delaware
Georgia Institute of Technology
Purdue University

View Center Website

Center Personnel

Eric Munson
Dane O. Kildsig Chair in Industrial and Physical Pharmacy, Department Head
+1 765 494 1450
munsone@purdue.edu

Andreas AndyBommarius
Professor
+1 404 385 1334
andreas.bommarius@chbe.gatech.edu

Christopher Roberts
Center Staff
+1 302 831 2136
cjr@udel.edu

Research Focus

Representative research areas include:

More selective and robust processes with less environmental footprint

Novel and improved existing biocatalysts, such as redox biocatalysts and hydrolases, from beta-lactam hydrolases to semisynthetic beta-lactams.

Integrated reaction-separation schemes

Integration of reaction and product/(bio) catalyst separation, with the goal of rapidly scalable, robust, and thus economical processes.

Methods to ensure long-term stability of tablets, proteins, and vaccines

Awards

1540017

I/UCRC Phase II: Collaborative Research: Center for Pharmaceutical Development (CPD)

Despite significant advances in the pharmaceutical industry over the last 50 to 100 years, there are still many problems with the drug supply, including drug shortages, drug manufacturing failures, drug recalls due to manufacturing issues, and problems with formulating and manufacturing new drugs that don?t dissolve or aren?t stable over time. The Center for Pharmaceutical Development focuses on increasing the safety and lowering the cost of drugs through research into the formulation and manufacturing of both innovator and generic drugs. The research interests of the center are threefold. First, the center is developing new biological catalysts that are used to synthesize drugs in a way that is more efficient and safer for the environment. Second, the center is improving analysis methods for determining what happens to the drug during the manufacturing process, and how that might lead to product failure. Finally, the center is focused on large-molecule drugs such as proteins and antibodies, which are emerging as potent new therapies. The societal benefit of this research would ultimately be cheaper and safer drugs for the patient. Despite huge progress in pharma over the last 50 to 100 years, there are still a lot of unmet needs which cause shortened lifespans and unnecessary suffering by patients. However, the development of novel drugs takes a lot of time (commonly more than 10 years) and money (commonly more than $1-2 billion). After discovery, the late-stage development begins, with clinical trials, manufacturing studies, especially process development and scale-up, and also with the development of the active ingredient into a drug product, such as a tablet, or an injectable. Development into a drug product requires solutions for formulation and drug delivery. The Center for Pharmaceutical Development (CPD) covers late-stage development in the development of new drugs; CPD focuses on manufacturing, formulation, and analytical tools. In the upcoming phase II (2015-2020), the CPD will operate at three sites: Georgia Tech (GT)/Emory in Atlanta, GA, the University of Kentucky (UK), in Lexington, KY, and now also at the University of Delaware in Newark, DE. Georgia Tech/Emory will focus on highly selective and environmentally benign biological catalysts and integration of reaction and separation (with Delaware); the University of Kentucky site will contribute with their unique strength in analyzing and stabilizing solid pharmaceuticals, both small molecules and therapeutic proteins (?biologics?) (with Delaware); and the University of Delaware will add strength in the separation and purification of therapeutic proteins (?biologics?) and in formulation, i.e. in keeping such biologic stable. The challenges above draw in a significant number of women and underrepresented minority students. Of the graduate students supported wholly or in part by the CPD, more than half (53%) were women and 18% were underrepresented minorities. Read More >

1939164

I/UCRC Phase II: Collaborative Research: Center for Pharmaceutical Development (CPD)

1540003

I/UCRC Phase I (Site): Center for Pharmaceutical Development U. of Delaware Site

The biopharmaceutical industry represents one of the most technically demanding, high impact industries in the United States and worldwide, and is a driver of scientific innovation and economic prosperity. One of the fastest growing, and most promising type of new drug candidates, are those based on proteins as the active ingredient. However, there are a number of long-standing, industry-wide challenges that occur during the development and manufacturing of such ?pharmaceutical proteins?. The proposed I/UCRC Site at the University of Delaware (UD) will bring world-class expertise to the existing Center for Pharmaceutical Development (CPD), in technical areas that are central to innovation for the development of pharmaceutical proteins (so-called biopharmaceuticals). Examples include: more efficient purification processes, better product stability and reduced risk of side effects or unwanted immunogenic responses in patients, and improved control of manufacturing processes. The proposed, expanded CPD will be the most far-reaching industry-university consortium to date that is focused on pharmaceutical product development, rather than the more traditional focus on ?upstream? research and drug-discovery activities. The project areas it will address have the potential to greatly improve the efficiency and economics of drug development science and engineering, as well as the fundamental understanding and education of engineers and scientists in the industry. This can benefit the U.S. broadly in terms of domestic job creation, as well as improved time to market, cost to patients, and reduced risk for investors, based on the development and testing of new therapeutic proteins (sole focus of the UD Site) and innovator pharmaceutical products more generally (focus of CPD overall). The major technical areas for the biopharmaceutical industry that are the focus on the UD site for the CPD include: (i) commercial and pilot-scale bioreactors to produce recombinant protein for use as a drug; (ii) extensive purification to produce essentially pure therapeutic protein in aqueous solution; (iii) formulation of the purified protein to assure multi-year stability, robust manufacturing, and effective delivery to patients; (iv) analytical technologies and instrumentation to support extremely tight specifications at each of stages (i) to (iii). The faculty in the proposed UD Site for the CPD are world-recognized leaders in areas (i) to (iv), and will provide new strengths to the current CPD that complement the existing expertise in solid-state pharmaceutical stability and delivery, and development of industrial enzymes and related biotechnology products. Read More >

The opinions, findings, and conclusions or recommendations expressed are those of the Center author(s) and do not necessarily reflect the views of the U.S. National Science Foundation.