Peck Symposium Speakers
Dr. Ruben Carbonell
Frank Hawkins Kenan Distinguished Professor of Chemical Engineering, North Carolina State University, Raleigh, NC
Ruben G. Carbonell is the Frank Hawkins Kenan Distinguished Professor of Chemical and Biomolecular Engineering at NC State University. He is on temporary leave as Executive Director of the Biomanufacturing Training and Education Center (BTEC) to serve as Chief Technology Officer of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). He is also Director of the Kenan Institute for Engineering, Technology & Science, which supports multi-disciplinary and multi-institutional research, educational, entrepreneurial and public policy programs.
Dr. Carbonell was elected to the National Academy of Engineering in 2014. He is a Fellow of the National Academy of Inventors, the American Institute of Chemical Engineers, and the Industrial and Engineering Chemistry Division of the American Chemical Society. Dr. Carbonell is a Foreign Member of the Slovenian Academy of Sciences and the Academy of Sciences of the Institute of Bologna. He has published over 240 technical papers and is an inventor in over 30 patents. Prof. Carbonell received his BS degree in Chemical Engineering from Manhattan College in 1969 and his PhD from Princeton University in the same area in 1973.
Challenges and Advances in Downstream Purification of Biopharmaceuticals
The biopharmaceutical industry is facing demands for cost reductions in medications in developed countries with aging populations, as well as in developing countries with growing middle classes. The advent of biosimilars has led to increased competition from other countries. In addition, regulatory constraints require enhanced potency, efficacy and safety while there is a need for rapid approval and deployment of life-saving vaccines, and novel gene-based and stem cell-based therapeutics.
There is a great deal of interest in the development of novel downstream processes to accelerate production, reduce process steps, process footprint, buffer and energy use, and regulatory burdens. Single use devices, low cost affinity media, membrane chromatography, process intensification, in-line validation and other approaches are being explored. Our group has pioneered the use of synthetic peptide libraries for the identification of low cost ligands with high affinity and selectivity for a wide variety of protein targets. In addition, we are pursuing inexpensive, high-throughput, high binding-capacity non-woven membranes as solid supports for product or contaminant capture. These developments might enable “truly continuous” purification strategies based on flow-through separation steps relying completely on disposable membranes.
Dr. Robert (Bill) Williams
Division Head and Professor of Pharmaceutics, Johnson & Johnson Centennial Chair in Pharmacy, University of Texas at Austin
Dr. Robert O. (Bill) Williams III is the Johnson & Johnson Centennial Chair and Division Head of Molecular Pharmaceutics and Drug Delivery at the College of Pharmacy, The University of Texas at Austin. He is an inventor on over 35 patents and patent applications and is the co-founder of several pharmaceutical companies. He received the Inventor of the Year award from the University of Texas at Austin in 2017. He was elected Fellow of the American Association of Pharmaceutical Scientists in 2006 and Fellow of the American Institute of Medical and Biological Engineering in 2008. He has published over 450 peer-reviewed research articles, reviews, abstracts and book chapters, and has co-edited two books, including Formulating Poorly Water Soluble Drugs, Second Edition (AAPSPRESS and Springer). Dr. Williams is Editor-in-Chief of AAPS PharmSciTech since 2014 and was Editor-in-Chief of Drug Development and Industrial Pharmacy from 2000 to 2014. He is on the Editorial Advisory Board of The Journal of Drug Delivery Science and Technology. He earned a B.S. in Biology from Texas A&M University, a B.S. in Pharmacy from the University of Texas at Austin and Ph.D. in Pharmaceutics in 1986 from UT Austin. Dr. Williams worked 9 years in the pharmaceutical industry.
Thermal Processing Enhances Drug Delivery of Poorly Water Soluble Drugs – Process Selection
Thermal processing, including hot melt extrusion and KinetiSol® Dispersing, are useful processes for formulating drugs with low water solubility in order to improve their properties, such as wetting, dissolution and bioavailability. Polymers are typically employed in these processes to formulate the drug as an amorphous solid dispersion. Thermally labile drugs and drugs that have a high melting point (e.g., greater than ~200°C) are often not suitable for processing by hot melt extrusion. KinetiSol® Dispersing, a high energy fusion process not requiring an external heat source, offers a suitable alternative to these difficult to formulate drugs. Processing times differ in terms of minutes versus seconds, for hot melt extrusion and KinetiSol® Dispersing, respectively. This talk will discuss hot melt extrusion and KinetiSol® Dispersing in terms of process selection and limitations, and will include examples of formulations exhibiting enhanced properties.
Dr. Dimitrios Peroulis
Deputy Director, Birck Nanotechnology Center, Professor of Electrical and Computer Engineering, Purdue University
Dr. Nien-hwa Linda Wang
Maxine Spencer Nichols Professor of Chemical Engineering, Purdue University
Dr. Nien-Hwa Linda Wang is the Maxine Spencer Nichols Professor of Chemical Engineering at Purdue University. She received her PhD in Chemical Engineering from the University of Minnesota in 1978. She is internationally known for her research contributions in separations, adsorption, ion exchange, multi-component chromatography, and simulated moving bed technologies.
Fundamental Principles and Enabling Technologies for the Design of Batch and Continuous Chromatography Processes
Chromatography methods are highly selective separation methods, which are required for manufacturing of many biochemicals and biopharmaceuticals. Advanced chromatography methods for manufacturing, however, are not taught in conventional science or engineering curricula. Many chromatography processes in industry are designed empirically, with poor yield, productivity, and solvent efficiency. In this talk, the fundamental principles of batch and continuous chromatography will be explained. Enabling technologies and tools, which will help understand, analyze, simulate, design, and optimize various types of chromatography processes, will be discussed. The knowledge and the advanced computer tools are useful for improving the efficiency of existing processes or designing more efficient processes to reduce manufacturing costs.
Dr. Mukerrem (Miko) Cakmak
Reilly Professor of Materials Engineering & Mechanical Engineering, Purdue University
Dr. Cakmak received his BS in Chemical Engineering from Technical University of Istanbul and MS and PhD in Polymer Engineering from University of Tennessee, Knoxville.
He was one of the founders of Polymer Engineering Department at University of Akron where he was named Harold A. Morton Chair and Distinguished Professor of Polymer Engineering. He recently was the founding director of the National Polymer Innovation Center where he developed roll to roll manufacturing lines for functional polymer films for a range of applications including membranes for batteries, biomedical devices such as artificial pancreas, slow drug release platforms, flexible transparent electrodes for flexible electronics and flexible sensors.
Dr. Cakmak’s current research includes modeling and experimental studies on processing–structure property relationships in polymer films and moldings and polymer/metal/ceramic hybrid systems.
Design and Modeling of Roll to Roll Continuous Lyophilization System
Authors: Miko Cakmak. Alina Alexeenko
Abstract: In this talk we will present a novel design of continuous roll to roll Lyophilization System and metrology tool. The machine designed has dual purpose. One is to produce thin layers of lyophilized materials and laser packaging. In the second function it was designed with metrology tool that will track weight loss, thickness during lyophilization. A basic modeling of the process was developed help predict the thickness changes and extent of lyophilization.
Dr. Ali Shakouri
Mary Jo and Robert L. Kirk Director of Birck Nanotechnology Center, Professor of Electrical and Computer Engineering, Purdue University
Dr. Qi (Tony) Zhou
Assistant Professor of Industrial and Physical Pharmacy, Purdue University
Dr. Qi (Tony) Zhou joined the Department of Industrial and Physical Pharmacy as an Assistant Professor in 2015. He obtained his PhD from Monash University of Australia in 2011, and received postdoctoral training at the University of Sydney. As a junior faculty, he has published 51 journal articles and secured >$4M research funding from Governments and industry, including NIH R01 and Bill & Melinda Gates Foundation grants. Dr. Zhou’s contributions to the field of pharmaceutical sciences have been recognized by many awards including 2013 Australian Early Career Fellowship, 2014 Australian Endeavour Fellowship, 2015 AAPS Postdoctoral Fellowship, 2016 IPEC Excipient Emerging Researcher Award and 2017 New Investigator Award in Aerosol Medicine. Dr. Zhou is an Editorial Board Member of Journal of Pharmaceutical Sciences, and Guest Editors of Current Pharmaceutical Design and Pharmaceutical Research.
Innovative technologies for spray drying and characterization of pharmaceutical solids
Abstract: The 21st century has seen many innovations in manufacturing of pharmaceutical solid, with purposes to improve production efficiency, formulation performance and product stability. As an example, spray drying has been increasingly employed for production of both small- and large-molecule pharmaceutical solids, attributed to the superior production efficiency and formulation flexibility. Over the past decade, there are some innovative technologies have been developed for spray drying. Also, some cutting-edge techniques have been applied to characterize physico-chemical properties of spray-dried solids, aiming to optimize the manufacturability, stability and therapeutic efficacy of the spray-dried products. This talk will summarize some advances in spray drying and characterization of pharmaceutical solids.
Dr. Rodolfo Pinal
Associate Professor of Industrial and Physical Pharmacy, Director of Center for Pharmaceutical Processing Research, Purdue University
Pharmaceutical Manufacturing in the Era of Patient-Centric Medicine
Biomedical advances are making it possible to quantitatively understand why is it that the same medication does not work the same in every patient, thus rendering the long-standing drug therapy practice of “one-dose-fits-all” outdated, for an increasing number of drugs. The pharmaceutical industry faces the challenge of how to apply the latest advances in process understanding achieved in recent years, along with the accompanying high standards of product quality achieved, as it moves into the era of patient-centric medicine (PCM). Namely, the “retooling” needed to create a product that instead of being a blockbuster, is a large collection of “mini-busters.” This requires the ability to cost-effectively produce product variations, covering an arbitrary number of different doses, and with a range spanning roughly two orders of magnitude (based on metabolic variability). Similar challenge arises for the manufacture of patient-specific, non-fixed combination products, bound to change over time even for the same patient, involving different number and APIs.
A platform for the design and manufacture of oral dosage forms (“pills”), developed to satisfy the patient-tailored (or subpopulation-tailored) requirements of PCM is presented. The approach is a paradigm shift, whereby pills are conceived as Integrated Systems, rather than as traditional compacts of powder blends. The manufacture of this new type of multiplexed pill (“3 D Pill”) is analogous to the manufacture of 3D Integrated Circuits. The oral dosage forms, modular in design, are made by assembling prefabricated components in 3 D stacks, where each prefabricated component performs a specific, pre-determined pharmaceutical function. Each prefabricated component is a polymer composite wafer, whose particular function in the assembly is determined by the type of material embedded with the polymer (active pharmaceutical ingredient, solubilizer, disintegrant, absorption enhancer, pH modifier, ID/anti-counterfeiting element, etc.). The Integrated Systems approach to drug manufacturing makes it comparatively to traditional manufacturing, a much simpler task to add or refine performance attributes of the pill, and/or quality related attributes to the dosage form by incorporation of additional/different functional composite wafers. The 3D Pill concept is fully patient-centric, such that precise dose adjustment, as well as drug release characteristics, can be achieved within the same platform, in order to meet the therapy requirements of the individual patient. The Integrated Systems approach to pharmaceutical manufacturing fully exploits the advantages of things like continuous manufacturing and QbD, provided that a slight but important shift in focus is adopted, thus suggesting that the “retooling” needed in industry to fulfill PCM needs, is rather one of “mindset,” and not so much one of facilities, processes or know-how.