PepTalk 2017
PepTalk 2017

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Cambridge Healthtech Institute’s Third 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 10-11, 2017 | Hilton San Diego Bayfront | San Diego, CA

Particles and impurities can come from the products, any stage of bioprocessing or the delivery devices and primary packaging and have potential to impact stability, safety, and 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 Third 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 We are looking for cutting-edge tools, research findings and unpublished data to be featured at this forum.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 attend to join colleagues in this discussion of the key challenges and solutions for prediction, characterization, and risk assessment of particles and impurities from products and processes.

We invite presentation proposals on the following preliminary topics:

  • Regulatory requirements and guidance 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
  • Development, qualification and implementation of biophysical and imaging-based methods
  • New methods for multiple attribute analysis for identification and impurity profile
  • Advanced mass spectrometry analytical methods for impurity profiling
  • Risk of immunogenicity posed by aggregate and impurities formation during formulation, bioprocessing and in product container or delivery device
  • Detection and distinction of various process and related impurities and link to bioactivity. Establishing relationship of impurity to potency and activity and how they affect patients, storage and shelf life. What modification should be monitored?
  • Formulation components and excipient-related impurities:
    • Understanding excipients stability and particles in biopharmaceuticals: case studies on surfactants that cause protein degradation and aggregations, stability issues arising due to drug-excipient interactions
    • Impact of product-related impurities such as aggregates, fragments, impurities contributed by chemical reaction and conjugation and posttranslational modification
    • Forced degradation and impurity characterization, case studies on impact of product and process impurities on stability of formulation
  • Effect 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: May 27, 2016

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

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

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