January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 
January 18-22, 2016 | Town and Country Resort Hotel | SAN DIEGO, CA 

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Cambridge Healthtech Institute’s Second Annual
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 19-20, 2016

Particles and impurities can come from the products, any stage of bioprocessing 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 Second Annual 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 We are looking for cutting-edge tools, research findings and unpublished data to be featured at this forum.

We invite you to submit a proposal, present a poster and join colleagues in this discussion of the key challenges and solutions for prediction, characterization, risk assessment of particles and impurities from products and processes.

We invite presentation proposals on the following preliminary topics: 

  • Regulatory requirements on particles and impurities for early and late-stage submissions
  • Subvisible particles: Rapid and high-throughput tools (HTS) for prediction, detection and characterization of subvisible particles and other aggregates
  • Prediction, characterization, risk assessment and impact of higher-order aggregates
  • Development, qualification and implementation of biophysical and imaging-based methods
  • Critical quality attributes assessment and control
  • Impact of product-related impurities such as aggregates, fragments, impurities contributed by chemical reaction and conjugation and posttranslation modification
  • Understanding excipients stability and particles in biopharmaceuticals: Case studies on surfactant that cause protein degradation and aggregations, stability issues arising due to drug-excipient interactions
  • Forced degradation and impurity characterization, case studies on impact of product and process impurities on stability of formulation
  • Impact of process-related impurities such as process variants, impurities from excipients, host cell proteins, residual solvents, leachables, etc.
  • Process monitoring and control strategies for minimizing particles and impurities
  • Risk of immunogenicity posed by aggregate formation during formulation, bioprocessing and in product container or delivery device
  • Impact of impurities from leachables from glass, single-use systems, glass delamination, tungsten particles, silicone particles, rubber stoppers and generation of visible and subvisible particles

Please click here to submit a speaking proposal for review.

Deadline for submission: June 17, 2015 

All proposals are subject to review by the Scientific Advisory Committee to ensure the overall quality of the conference program. Please note that due to limited speaking slots, preference will be given to abstracts from those within pharmaceutical and biopharmaceutical companies, regulators and those from academic centers. Additionally, as per CHI policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships. 

For questions about the meeting, please contact: 

Nandini Kashyap
Conference Director
Cambridge Healthtech Institute
Phone: 781-972-5406
Email: nkashyap@healthtech.com 

For partnering & sponsorship information, please contact: 

Companies A-K
Jason Gerardi
Manager, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5452
Fax: 781-972-5470
Email: jgerardi@healthtech.com 

Companies L-Z
Carol Dinerstein
Director, Business Development
Cambridge Healthtech Institute
Phone: 781-972-5471
Fax: 781-972-5470