Cutting-Edge Research on Nanomanufacturing, Biopharmaceuticals, Medical Devices & Diagnostics

Conference Schedule Day 1: October 19, 2009

Researchers will present in succession, followed by a panel discussion w/questions and answers, time permitting.
Please note that the following conference schedule and lineup is subject to change.
Morning Session, 8:30am-noon
Biopharmaceuticals and Bioprocessing

Innovative Technologies in the Manufacture of Biopharmaceuticals
Carl W. Lawton, Director, Massachusetts Biomanufacturing Center, University of Massachusetts Lowell, Lowell, Mass., U.S.
Recent advances in innovative technologies address critical issues in the manufacture of biopharmaceuticals.  This presentation will discuss work performed at the Center to evaluate UCOE (ubiquitous chromatin opening elements) for stabilizing gene expression, single use membrane chromatography, and ozone CIP (clean in place).
Developing Immunoassays for Bioprocess Analysis and Diagnostics
Richard O’Kennedy, Professor of Biotechnology and Vice-President for Learning Innovation, Dublin City University, Dublin 9, Ireland.
Antibodies are ideal reagents for use in assay development and genetic engineering facilitates optimisation of their performance characteristics in terms of specificity, sensitivity, structural format, stability and immobilization. Their generation and potential applications in a range of diagnostic and process-related analyses using sensors and other platforms will be described.
Ireland’s Center for BioAnalytical Sciences (CBAS): A Biopharmaceutical Perspective
Senior Representative from the Center for BioAnalytical Sciences
CBAS is an industry-academia collaboration utilizing the best academic research skills to resolve shared problems associated with research-intensive bioindustries. Based on the experience gained from the initial partnership, the concept is now expanding and is being utilized to bring novel and advanced bioanalytical solutions to the biopharmaceutical and life science industry sectors, including novel diagnostic and nanotechnologies.
Better Enzymes for Biosensors
Ciarán Fagan, School of Biotechnology and National Centre for Sensor Research, Dublin City University, Ireland
Enzymes have many uses but their scope is limited by protein instability. We have performed chemical modification (CM) and genetic manipulation (GM) on the widely-used horseradish peroxidase (HRP). The lecture will show how these have led to more stable forms HRP. Biosensor-relevant improvements to HRP and another peroxidase will also be described.
Covalent Aggregation of Protein Therapeutics: A Case Study
Jin Xu, Director of Protein Sciences, Massachusetts Biomanufacturing Center, University of Massachusetts Lowell
Protein aggregation is a major concern of biomanufacturing. In this study, various biochemical, biophysical and molecular biology techniques were employed to elucidate the disulfide bond-related mechanism of protein aggregation.

Physical-Chemical Sensors: Application to Bioreactor Monitoring and Control
Richard Baggio, Senior Research Scientist, Millipore
Real-time bioprocess monitoring is fundamental to maximize yield, improve efficiency and process reproducibility, minimize costs, optimize product quality, and fully understand how a system works.  These results offer insight into how the application of new optical probes and both NIR and dielectric spectroscopy can more fully integrate the PAT initiative in a bioreactor workflow to improve product quality.

Panel Discussion

Afternoon Session, 1:00pm-4:30pm
Medical Device Technologies
Novel Medical Devices from Massachusetts Start-Ups
Stephen McCarthy, Co-Director M2D2, University of Massachusetts Lowell, Lowell, Mass., U.S.
An overview of M2D2 (Massachusetts Medical Deice Development Center) and the current medical devices being developed will be presented.  These novel devices include biodegradable drug eluting stents, nanosphere-antibiotic corneal contact lens, photochemical tissue bonding, and RF bone welding.
Bone Substitute Materials
Dr Nicholas Dunne, School of Mechanical & Aerospace Engineering, Queen’s University Belfast, Northern Ireland, UK.
Calcium phosphate cements have attracted a great deal of interest as possible bone substitute materials due to their ability to produce hydroxyapatite demonstrating chemical and crystallographic structures similar to that naturally present in bone. Calcium phosphate cements can be delivered through a cannulated needle to an anatomical site or molded to a desired shape to fill a bone defect. However, calcium phosphate cements are recognised for their low compressive strength and susceptibility to brittle fracture, which significantly limits their use in load-bearing orthopaedic applications.  This presentation will explore different strategies for augmenting the load-bearing
A Flexible Method for the Preparation of Tissue Engineering Scaffolds
Daniel Schmidt, Assistant Professor of Plastics Engineering, University of Massachusetts Lowell, Lowell, Mass., U.S.
One of the major barriers to successful regenerative medicine is the availability of appropriate scaffolds on which living tissue is able to form. Here, organic sol-gel chemistry is presented as a novel approach to the creation of such scaffolds. This flexibility of this method comes from its general applicability to a wide range of polymeric materials, as well as the possibility to alter structure independent of composition or vice-versa. Additional examples of the ability to achieve multifunctionality include the replication of biologically relevant porous bodies, the preparation of materials with shape-memory characteristics and the selection of materials designed to produce potentially therapeutic degradation products.
Tailoring Resorption Rates of Biodegradable Polymers
Dr Fraser Buchanan, Reader, School of Mechanical and Aerospace Engineering, Queen's University, Belfast, Northern Ireland, UK
Bioresorbable polymers such as polylactic acid (PLA), polyglycolic acid (PGA) and copolymers are widely used in medical devices, however their degradation behavior is not ideal as they tend to lose strength well before any significant loss in mass. This presentation will cover methods to evaluate bioresorbable polymers, including accelerated ageing, as well as approaches to tailor the degradation rate.
Overcoming the Challenges of Clinical Trials for Medical Devices
Sheila Noone,  Assistant Vice Provost for Clinical Research, University of Massachusetts Worcester, Worcester, Mass., U.S.
All clinical trials, including medical device studies, rely on an efficient and reliable infrastructure to ensure success. This is a particular challenge in a highly matrixed academic health center. This presentation will highlight the shared responsibilities of sponsor, institution and research staff over the life cycle of the clinical trial to achieve study success.
Supercritical Fluid Assisted Processing of Polymers for Medical Use
Peter Hornsby, Queens’s University Belfast, Northern Ireland, UK
Supercritical carbon dioxide can exert a strong transient plasticizing effect to many polymers during melt processing resulting in decreased viscosity, thereby providing an opportunity to reduce processing temperatures or limit mechanical damage to the material. The application of this approach will be discussed with reference to extrusion technology and the processing benefits achievable, including its use with inherently thermally unstable polymers and modifying additives used for medical purposes.
Multifunctional Additives for Medical Polymers
Tony McNally PhD, Queen's University Belfast, Northern Ireland, UK
This presentation will be divided into 2 parts. Firstly, the role of ionic liquids as both plasticisers and antimicrobial agents for use with PVC and secondly, the use of nanoparticles to retard drug release from biopolymers will be described.
Panel Discussion

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