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Cambridge Healthtech Institute’s Inaugural
Detection and Characterization of Particulates and Impurities
Rapid Tools and Strategies for Risk Assessment, Prediction and Characterization of Particles and Impurities from Products, Excipients and Processes
January 21-22, 2015


Particles and impurities can come from the products, any stage of processing or the packaging containers. The presence of particulates and impurities in the drug product can impact stability, safety, efficacy of the biomolecules and biologic products. Therefore, early understanding, detection and characterization of the impurities are critical to ensure safety and efficacy of the drug product for its intended duration of use. The Detection and Characterization of Particulates and Impurities conference provides a platform to explore novel tools and strategies to detect, characterize and carry out risk assessment of particles and impurities.

We invite you to join colleagues in this discussion of the key challenges and solutions for prediction, characterization, risk assessment of particles and impurities from products and processes, and see how experts like you are developing a scientifically sound formulation to deliver a safe and stable biologic drug product.

Preliminary Agenda 



CHARACTERIZATION AND RISK ASSESSMENT OF PARTICLES AND IMPURITIES


FEATURED PRESENTATION 

Strategies for Characterization and Risk Assessment of Particles, Degradants and Impurities

Satish Singh, Ph.D., Research Fellow and Group Leader, Pfizer; Member, 787 Expert Panel, U.S. Pharmacopeial Convention (USP)

Stability Challenges for Protein Therapeutics: Characterizing Aggregation Propensity and Further Formation of Sub- Visible Particles

Joël Richard, Ph.D., Vice President, Peptides, CMC & Engineering, Ipsen


ORTHOGONAL TOOLBOX FOR SIZING AND COUNTING OF SUB-VISIBLE PARTICLES

Detection and Characterization of Visible, Sub-visible Particles and Other Aggregates: Achievements and Challenges

Anacelia Rios Quiroz, M.Sc., Assistant Scientist, Late-Stage Pharmaceutical and Process Development, Pharmaceutical Development & Supplies, PTD Biologics Europe, F. Hoffmann-La Roche Ltd.

Use of MFI Instead of HIAC for Particle Count

Mitesh Acharya, Ph.D., Manager, Quality Control, Regeneron Pharmaceuticals, Inc.

Factors Influencing the Sizing and Counting of Sub-visible Particles by Orthogonal Methods

Richard Cavicchi, Ph.D., Physicist, Bioprocess Measurements Group, National Institute of Standards and Technology


RAPID SCREENING OF IMPURITIES FROM PRODUCT AND EXCIPIENTS

A High-Throughput Coupled Methodology for Quantitation of Iso-Aspartate Formation in Proteins and Peptides

Ajit S. Narang, Ph.D., Senior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb Co.

Characterization of Antibody-Drug Conjugates and Control Strategies for Small Molecule Impurities

Juma Bridgewater, Ph.D., Scientist, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

Advances in the Detection and Characterization of Sub-visible and Visible Particles and Other Aggregates

Andrea Hawe, Ph.D., CSO, Coriolis Pharma

Excipients and Proteins at Air-Aqueous Interface in the Immunoassay Formulation Development

Alfredo R. Narvaez, Ph.D., Manager, Diluent Research & Formulation Group, Global Process Design R&D, Abbott, Inc.

Identification of Particulates in Biopharmaceutical Formulations Using Vibrational Spectroscopy

Miguel Saggu, Ph.D., Associate Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.


HIGH-THROUGHPUT DETECTION AND CHARACTERIZATION OF PROCESS-RELATED IMPURITIES

High-Throughput Analytical Development to Support BioProcess Monitoring: Case Study on SEC, Peptide Mapping and HCP Assays

Xiaodun (Susan) Mou, Ph.D., Associate Principal Scientist, BTE, Merck & Co., Inc.