Biopharmaceutical / Biomanufacturing
Industry Training

Questions? Call us at (978) 934-2473!

To register for the following seminars, please call (978) 934-2405 or download and complete the Registration Form, contact Karen von Sneidern at (978) 934-2473 or email Karen_vonsneidern@uml.edu

Who Should Attend
The program is designed for bioprocess engineers, biochemical engineers, validation engineers, production managers, biochemists, cell biologists, microbiologists, molecular biologists in manufacturing, QA, QC, regulatory and R&D in the biopharmaceutical and biotechnology industries.

Location
Held on UMass Lowell's North Campus. Participants will receive directions and a map upon registration.

Tuition-Save 40% When You Register for All Six Sessions!
$1800 for all six sessions or $500 for each individual session. To register for all six sessions at a discounted rate, use course# 00.630-041

• Biological Sciences and the Biotech Industry
• Historical Trends and the Future
• The Biopharmaceutical Regulatory Environment
• Biochemistry and Cell Biology Review (from DNA to Protein)

• Expression Systems (microbial and mammalian)
• Protein Expression Gene Cassette
• Master and Working Cell Banks

• Media Optimization
• Batch, Fed Batch, and Perfusion
• Scale-up and Scale-down

• Protein Structure and Function
• Protein Aggregation and Degradation
• Filtration
• Centrifugation

• Chromatography
• Assembly of Recombinant Protein Purification Process

• Protein Sciences in Biotech R/D
• Product Isoforms
• Biochemical/Biophysical/Mass Spec Characterization Package
• Release Assays and Specifications
• Formulation

Analytical Development and Characterization of Protein Therapeutics
January 20, 21, & 22

Tuition-Save 25% When You Register for All Three Sessions!
$1800 for all three sessions or $800 for each individual session. To register for all three sessions at a discounted rate, use course #00.920-041

Program Description
Protein analysis and characterization is a central element of the biopharmaceutical industry.  Understanding the structure and function of protein therapeutics and related isoforms is essential for drug candidate screening, manufacturability assessment, process development/optimization, formulation development, QA/QC, regulatory and other areas of biomanufacturing.  The Analytical Development and Characterization of Protein Therapeutics Training Program at the University of Massachusetts Lowell Biomanufacturing Center provides scientific and technical training to protein chemists as well as scientists and engineers from all areas of the biotechnology and biopharmaceutical communities.  The program provides an overview of protein structure, protein folding, posttranslational modifications, aggregation and degradation.  The scientific theory behind biochemical, biophysical and mass spectrometric technologies, as well as their practical applications in biopharmaceutical analysis and characterization, will be covered in detail.  A pair of case studies focusing on a monoclonal antibody and a fusion protein product will provide a complete picture of analytical and characterization design, experimental approaches, data interpretation, and its impact on R&D and manufacturing.  The program will include demonstrations in our newly established Massachusetts Biomanufacturing Center Protein Sciences Laboratory to help bridge the theoretical background with practical solutions.
 
Who Should Attend
The program is intended for protein chemists, cell biologists, microbiologists, molecular biologists, bioprocess engineers, validation engineers, project managers and production managers from R&D, manufacturing, QA, QC, regulatory and other disciplines relevant to the biopharmaceutical and biotechnology industries.

• Protein and Antibody Structures
• Posttranslational Modifications
• Protein Folding, Misfolding and ERAD
• Aggregation and Degradation
• Heterogeneity in Recombinant Proteins

• HPLCs (size exclusion, ion exchange, reversed phase, hydrophobic interaction and affinity)
• Electrophoresis and Capillary Electrophoreses
• Mass Spectrometry
• Spectrophotometry (UV/vis, fluorescence and circular dichroism)
• Light Scattering (static and dynamic)
• Analytical Ultracentrifugation
• Surface Plasmon Resonance (BiaCore) and MicroCalorimetry

• A Complete Characterization and Analytical Package for an Antibody Product
• Structural Heterogeneity and Aggregation of a Fusion Protein Product