BIOPOLYMERS - Advances in Medical and Material Science Applications

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Overview

The Biopolymers conference will take place as scheduled.

Our deepest sympathy's go out to the people involved in the widespread tragedy of Tuesday, September 11, 2001. There are no words to describe the senselessness of this horrible act. Our thoughts are with the families at this time.

Sincerely,
Craig Wohlers
President

Dramatic increases in the use of biopolymers will result in the growth of product development and manufacturing in the medical and material sciences. Keeping up with the diversification of bioploymer products and techniques will be the key to maintaining the competitive edge, both in industry and academics. Benefit directly from the internationally recognized academic, government and industry leaders who will speak on:

* Orthopaedic Synthetic Bioresorbable Polymers
* Tissue Engineering: Material Design and Cellular Response
* Alternatives to the Use of Collagen Derived Sutures
* Resorbable Scaffolds and Drug Delivery Implants
* From the Thermoplastic Starch to the New Starch
* Polymers and Composites from Genetically Engineered Plants
* Physical and Mechanical Properties of Starch-based Plastics
* Natural Inspired Chemical Building Blocks
* Hydrophilic/Hydrophobic Biodegradable Biopolymers
* Polymers from Renewable Resources and Natural Processes
* Structure Property Degradability Relationships of Alliphatic Polyesters
* Bioengineered Polymers - Proteins and Polysaccharides
* Materials Characterization in Device Biocompatibility
* Bioresorbable Hydrogels from Hyaluronan
* DNA Mimics as Environmentally Benign Photoreactive Polymers
* Hydrolytic and Enzymatic Degradation of Biodegradable Polymers
* Synthesis and Characterization of Biodegradable Polyester Ionomers
* Novel Processing-Blending Techniques with Biodegradable Polymers
* Principles of Biodegradation from the Perspective of the Microorganisms

Mark your calendars not to miss this networking opportunity to learn of the latest in biopolymer research. Register today!

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Agenda

Monday, October 15, 2001

8:00 Registration, Poster/Exhibit Set Up, Coffee and Pastries

Medical Applications of Biopolymers

8:50 Session Chairperson's Opening Remarks
Arthur Coury, Ph.D., Vice President, Biomaterials Research, Genzyme Corporation

9:00 Tissue Engineering: Material Design and Cellular Response
Prasad V. Shastri, Ph.D., Department of Materials Science and Engineering and School of Medicine, University of Pennsylvania and Department of Chemical Engineering, MIT

Tissue Engineering (TE) is the regeneration of functional tissue using cells and a polymeric template. TE offers the possibility of using donor cells to engineer replacement tissue. However, the evolution of cells into functional tissue is governed by many factors including template material characteristics, cell source and biological environment. This talk will cover methodologies in material design, cell selection and biomolecular definition in musculo-skeletal repair.

9:30 Characterization of the Mechanical Properties of Orthopaedic Synthetic Bioresorbable Polymers
Gladius Lewis, Ph.D., Professor, Department of Mechanical Engineering, The University of Memphis

The thrust of the presentation is a critical examination of the methods in current use for determining the mechanical properties of synthetic bioresorbable polymers (SBPs) relevant to their use for orthopaedic applications. The emphasis will be on a comparison of values of such properties (for example, tensile modulus and flexural strength) for a wide collection of SBPs, obtained in various test media, when the specimen is subjected to static loading and when it is subjected to in cyclical loading. Recommendations for the development of appropriate testing protocols, stemming from the observations gleaned from the aforementioned comparison exercise, will be presented.

10:00 Three-Dimensional Fabrication of Resorbable Scaffolds and Drug Delivery Implants
Jill K. Sherwood, Ph.D., Group Leader, Implants and Tissue Engineering R&D, Therics, Inc.

The creation of unique three-dimensional products such as scaffolds for tissue engineering or implantable drug delivery systems can be achieved using the TheriFormTM process, which allows control over both structure and composition. This process is ideal for resorbable polymers since it does not use any heat. In addition, many parameters can be controlled that are not possible with traditional techniques. Anatomically accurate tissue engineering scaffolds can be made from MRI or CT scans for custom scaffolds or off-the-shelf products. Since this process fabricates products in layers, internal features such as channels can also be incorporated. The material composition can be varied throughout the device to create regions of different mechanical properties within a scaffold or to fabricate drug delivery systems with complex release profiles. Specific examples include implants for hormone replacement and scaffolds for articular cartilage repair.

10:30 Refreshment Break and Poster/Exhibit Viewing

11:00 Alternatives to the Use of Collagen Derived Sutures
Mark S. Roby, Ph.D., Vice President, U.S.Surgical/D&G Research and Development

The purpose of this presentation is to review the effect of Bovine Spongiform Encephalopathy (BSE) on the suture market. BSE, commonly known as "Mad Cow Disease" has resulted in heightened public concern over the use of bovine-derived products. One such product is catgut suture manufactured from bovine collagen. Catgut suture has been utilized in wound closure for literally thousands of years. However, it has been displaced, in large part, by the development of synthetically based materials over the past 50 years. Specifically, manufacturers have developed synthetic absorbable braids beginning during the 1970's and synthetic absorbable monofilaments beginning during the 1980's. This presentation will review current products as well as those in development as viable replacements for catgut suture.

11:30 Materials Characterization: Essential to Medical Device Biocompatibility
Dave Albert, Ph.D., Senior Scientist, NAMSA

The importance of polymers to the medical device industry, especially plastics, cannot be over emphasized. Along with increased demand for medical grade plastics, the medical device industry has renewed its awareness to ensure the safety of materials used. This renewed awareness of the safety of medical devices has taken on an international characteristic largely because of FDA and International Organization for Standardization (ISO) standards. As international standards, including ISO 10993-1 to 18 continue to develop, it is becoming common to hear discussions of meeting "global" biocompatibility requirements. In fact, manufacturers today are more interested in performing their testing only once in order to satisfy regulatory bodies in all the countries where they intend to sell their products. Materials characterization as it relates to biocompatibility is likely to receive considerable attention in the future. Because characterization is so essential, the ISO 10993-1 contains a flowchart in which the first box instructs the user to characterize the material before proceeding to biological or toxicological testing.

12:00 Bioresorbable Hydrogels from Hyaluronan as Surgical Adjuncts and Drug Delivery Matrices
Arthur Coury, Ph.D., Vice President, Biomaterials Research, Genzyme Corporation

Hualuronan is a natural polymer found in many body tissues. When isolated and chemically modified, it can form resorbable hydrogels with properties that are useful for a range of therapeutic applications. Prominent among these are barrier films to prevent surgical adhesions, visco-elastics to lubricate joints, and protective gels for ocular surgery. Emerging uses include bioactive device coatings and drug delivery matrices.*In collaboration with James Burns, Robert Miller, Nancy Larsen, Adele Leshchiner, Pericles Calias, Erika Johnston, Kevin Skinner, Keith Greenawalt, Holly MacGregor and Li-Ping Yu, Genzyme Corporation.

12:30 Lunch, Sponsored by The Knowledge Foundation

Behavioral Characteristics of Degradable Biopolymers

1:55 Session Chairperson's Remarks
David L. Kaplan, Ph.D., Professor, Department of Chemical & Biological Engineering, Tufts University

2:00 DNA Mimics as Environmentally Benign Photoreactive Polymers
John C. Warner, Ph.D., Director of Biochemistry, University of Massachusetts-Boston

Synthetic polymers with pendant Thymine heterocycles have been shown to undergo photodimerization and crosslinking upon exposure to UV irradiation. This 2pi+2pi photocycloaddition occurs naturally in DNA and has been linked to skin cancer and other photoinitated diseases. Mechanistic interpretation and practical applications will be presented.

2:30 Synthesis and Characterization of Biodegradable Polyester Ionomers
R. F. Storey, Ph.D., Professor, School of Polymers
and High Performance Materials, The University of Southern Mississippi*

Incorporation of ionic groups into hydrolytically degradable polymers can provide a mechanism for triggering biodegradation, through counterion exchange. Ionic groups can potentially also have favorable effects on material properties such as heat distortion temperature. Two methods for incorporation of carboxylic acid groups into poly(lactic acid) (PLA) will be discussed. One is the copolymerization of L-lactide and 5-methyl-5-benzyloxycarbonyl-1,3-dioxan-2-one (MBC). The other involves chain extension of hydroxy-terminated PLAs with L-lysine diisocyanate. Structure and properties of the neutralized ionomers will be discussed. *In collaboration with: B. D. Mullen and J. M. Messman, The University of Southern Mississippi.

3:00 Hydrolytic and Enzymatic Degradation Characteristics of Biodegradable Aliphatic Polyesters
Suming Li, Ph.D., Senior Scientist at National Center For Scientific Research (CNRS), Centre de Recherche sur les Biopolymers Artificiels, Faculty de Pharmacie, France

Aliphatic polyesters, especially those derived from lactide (PLA), glycolide (PGA) and e-caprolactone (PCL), are being investigated worldwide for applications in the field of surgery (suture material, devices for internal bone fracture fixation), pharmacology (sustained drug delivery systems), and tissue engineering (scaffold for tissue regeneration). This is mainly due to their good biocompatibility and variable degradability. These polymers present also a growing interest for environmental applications in agriculture (mulch films) and in our everyday life (packaging material) as the development of biodegradable materials is now considered as one of the potential solutions to the problem of plastic waste management. For both biomedical and environmental applications, it is of major importance to understand the degradation characteristics of the polymers. The hydrolytic degradation of aliphatic polyesters has been investigated by many research groups. Our group has shown that degradation of PLAGA large size devices is faster inside than at the surface.

3:30 Refreshment Break and Poster/Exhibit Viewing

4:00 Novel Processing-Blending Techniques with Biodegradable Polymers
Stephen P. McCarthy, Ph.D., Professor, NSF Biodegradable Polymer Research Center, University of Massachusetts-Lowell*

Fibers and films with nanophase morphologies were investigated. Reactive processing methods were employed to form co-continuous, immiscible, compatible blends between poly lactic acid and other biodegradable polyesters. These blends included poly butylene succinate-co-adipate, poly caprolactone, and poly ethylene terephthalate copolyesters. These co-continuous blends exhibited a dramatic increase in ductility and biodegradation rate as compared to poly lactic acid. The formation of nano-layered films as well as sheath core nano-fibers, and hollow fibers were investigated. The effect of morphology, crystallinity and physical aging on mechanical properties and biodegradation was studied. In addition the use of these fibers as braided scaffolding for tissue growth was also carried out in collaboration with UMass Medical School. *In collaboration with B. Koroskenyi and R. Nicolosi, Biodegradable Polymer Research Center, University of Massachusetts-Lowell

4:30 Principles of Biodegradation From the Perspective of the Microorganisms
Steve Goodwin, Ph.D., Professor, Department of Microbiology, University of Massachusetts-Amherst

This speaker regrettably cancelled a week prior to this conference. He was unable to supply a replacement.

4:30 End of Day One

Tuesday, October 16, 2001

8:15 Poster/Exhibit Viewing, Coffee and Pastries

Structural chemistry of biopolymers

8:50 Session Chairperson's Opening Remarks
Jill K. Sherwood, Ph.D., Group Leader, Implants and Tissue Engineering R&D, Therics, Inc.

9:00 Bioengineered Polymers - Proteins and Polysaccharides
David L. Kaplan, Ph.D., Associate Professor, Department of Chemical & Biological Engineering, Tufts University

The interface between biology and polymer science and engineering provides new avenues for the manipulation of protein and polysaccharide structures. Tailored structures achievable through biological processes provide the materials from which to gain new insights into polymer assembly and functional properties. This insight can provide the basis for improved designs of materials, as well as predictors of structure-assembly and function issues, leading to improved specialty polymers and materials for a wide range of possible applications. Genetic engineering, manipulation of whole cell physiology and enzymatic synthesis in vitro are methods employed to achieve control of polymer structure. Examples of ongoing research will be presented to provide an overview of the opportunities being employed to improve our ability to bioengineer polymer structures and the resulting insights into assembly and function.

9:30 Hydrophilic/Hydrophobic Biodegradable Multi-Component Polymers
Samuel J. Huang, Ph.D., Professor, Institute of Materials Science, University of Connecticut

Biodegradable polymers with controllable life times are important for biomedical applications. Traditionally aliphatic polyesters such as poly(lactic acid), poly(glycolic acid), polycaprolactone, and their copolymers are used. These hydrophobic polymers, when implanted in the body cause protein deposition and eventually leads to scarf tissue formation. Since bio-surfaces are mostly hydrophilic degradable polymers with both hydrophilic/hydrophobic characteristics are more suitable for applications inside the body. Copolymers, semi-interpenetrating networks, and interpenetrating have been designed, synthesized and tested for implants and drug release systems. They are better biomaterials than the individual hydrophilic or hydrophobic components.

10:00 Refreshment Break and Poster/Exhibit Viewing

10:30 Structure Property Degradability Relationships of Alliphatic Polyesters
Yoshiharu Kimura, Ph.D., Professor, Department of Polymer Science and Engineering, Kyoto Institute of Technology, Japan

This speaker regrettably cancelled a week prior to this conference. He was unable to supply a replacement.

10:30 Physical and Mechanical Properties of Starch-based Plastics
Greg M. Glenn, Ph.D., Lead Scientist, Cereal Products Utilization Research, USDA-ARS, Western Regional Research Center*

A starch-based plastic was prepared by compression molding a microcellular starch foam. The foam was prepared from a starch gel that was dehydrated by solvent extraction. Mechanical tests showed that the starch plastics had good tensile strength and modulus but low elongation to break. The mechanical properties improved by incorporating fiber in the starch matrix. Potential applications will be discussed. *In collaboration with W. J. Orts and A. R. Nobes, USDA-ARS, Western Regional Research Center.

Natural Polymers

11:00 Session Chairperson's Opening Remarks
Dave Albert, Ph.D., Senior Scientist, NAMSA

11:05 From the Thermoplastic Starch to the "New Starch": the Holy Grail
Ivan Tomka, D.sc., Federal Institute of Technology, Zurich, Switzerland

The ideal "biodegradable/biocompatible thermoplast" should at least fulfill the following criteria: 1) replace polyolefins (PO) and polyvinylchloride (PVC) regardless which properties are looked for, 2) the total production cost should match that of PO and PVC, and 3) the full metabolic burning time should not exceed two composting cycles (30 days) in a technical composting unit. We may cluster these products in two large groups: those containing low molecular weight plasticisers (prohibitive for food packaging applications) and those, which are free of such diffusive components. At the end it appears that the final goal to use "the biodegradable/biocompatible thermoplast" on the large scale is still far away.

11:35 Polymers from Renewable Resources and Natural Processes: A Revival and an Extension of the Role of Nature in the Polymer Industry
Graham Swift, President, GS Polymer Consultants

The use of natural resources is not new in the development of human civilization. They were for many centuries the mainstay of development of industries and businesses that advanced civilization. Most of us in the chemical and polymer industries are well aware of the part played by "chemicals and polymers from nature" in these developments. However, we are also keenly aware that the role of renewable resources and natural processes diminished rapidly and significantly in the chemical industry as we went successively into the coal and petroleum based eras. We have come full circle and now recognize that neither of these two resources is forever and each is associated with negatives that encourage the search for alternative routes to commercially viable polymers and materials for select applications. This search, not really unexpectedly, has taken us back to our roots, natural renewable resources and natural processes. Exciting leads are coming forth including, new uses for already known and used natural polymers and their derivatives, the development new polymers from monomers obtained from natural resources, the development of new naturally occurring polymers, and the use of natural processing such as the specificity of enzyme catalysis. Using current developments in the field and particularly those I am associated with as examples, this paper will attempt to determine just how and where these opportunities factor into the growth of the polymer industry, how and where they will compete with current commodities, and where they are likely to succeed.

12:05 Lunch on Your Own. Exhibits/Poster Viewing

1:30 Chemical Building Blocks for Industrial Products: A Natural Inspired Solution
Robert van Tuil, Ph.D., ATO, Business Unit Renewable Raw Materials, The Netherlands*

The large demand of petrochemical based products, for instance plastics, and polymer additives such as plasticisers, has led to chiefly optimised product chains in terms of the economics and performance of the product, as well as in aspects such as process optimisation and environmental impact. However, there is a current resurgence in the interest of sustainable natural products for the preparation of alternative plasticisers, alternatives to aromatic structures, diols and diacids. At ATO some recent advancements in the chemical and biotechnological transformation and utilisation of sustainable resources, make it possible to interject into existing product chains with chemicals that are prepared from a sustainable natural origin. In this current paper it will be discussed how synthetic pathways to prepare monomers, suitable for the synthesis of desired existing man-made polymers, may be obtained using natural raw materials. The advantages of the approach taken will be discussed in terms of the sustainability of the resources used and the usefulness of biotechnology in combination with established technologies to create a compact route from research to technically and economically desired end product. *In collaboration with Elinor Scott, Ruud Weusthuis and Maarten van der Zee, ATO, Business Unit Renewable Raw Materials, Wageningen, The Netherlands.

2:00 Polymers and Composites from Genetically Engineered Plants
Richard P. Wool, Ph.D., Professor, Department of Chemical Engineering, ACRES Program, Center for Composite Materials, University of Delaware

Recent advances in genetic engineering of plants, natural fiber development, triglyceride oil chemistry and composite physics offer significant opportunities for new improved materials from renewable resources (soybeans, maize, sunflower, linseed, Mazola, cotton oil, wheat, olives, grass, etc.) that can be biodegradable and/or recyclable with enhanced support for global sustainability. Several examples of the design and manufacture of new genetically engineered plant-based plastics and adhesive materials for high volume applications will be presented.

2:30 Roundtable Discussion: Emerging Opportunities in Biopolymer Applications
Arthur Coury, Genzyme Corporation
Stephen P. McCarthy, University of Massachusetts-Lowell
Jill K. Sherwood, Therics, Inc.
Robert van Tuil, ATO
Dave Albert, NAMSA

3:00 End of Conference

Call for Posters

Call for Posters
Industry and academic scientists are encouraged to submit poster titles for this event. One-page abstracts (8 1/2” x 11” with 1-inch margins) must be submitted no later than September 15, 2001 for inclusion in conference documentation. Additional poster submissions will be accepted until October 1, 2001 but may not be included in conference documentation.

Note: If you're submitting a poster, you MUST be registered and paid in advance to ensure that a posterboard is reserved for you.

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