Cambridge Healthtech Institute's Fourth Annual
Detection and Characterization of Particulates and Impurities
( 微粒子与杂质的检验及特性评估 )
Rapid Tools for Risk Assessment, Prediction and Characterization of Impurities from Products, Excipients, Processes and Packaging
2018年1月9日 - 10日
Particles and impurities can arise from the products and/or during any stage of bioprocessing or from the delivery devices and primary packaging. These impurities have the potential to 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 Fourth 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 such as sub visible particles, host cell proteins, extractables and leachables, impurities from excipients and raw materials, glass and other particles, etc. We are looking for cutting edge tools, research findings and unpublished data to be featured at this forum.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 with 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 and guidance on particles and impurities for early and late stage submissions
- Rapid and high-throughput tools (HTS) for prediction, detection and characterization for sub-visible and sub-micron particles
- Risk of immunogenicity posed by aggregate and impurities formation during formulation, bioprocessing and in product container or delivery device
- Analytical tools: Biophysical and imaging based methods, advanced mass spectrometry, multiple attribute analysis for identification and impurity profile
- Process related impurities: Host cell Proteins (HCP), 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, raw materials and excipient related impurities
- Effect of impurities from leachables from glass, single use systems, glass delamination, tungsten particles, silicone particles, rubber stoppers, and generation of visible and sub visible particles
- Understanding mechanism of interaction between E&L and proteins and its impact on stability, potency and immunogenicity of drug substance and drug product
- Biocompatibility and product contact assessment: New tools, new and improved in vitro/in vivo models and studies, device and container closure safety