Cambridge Healthtech Institute’s Seventh Annual
Lyophilization and Emerging Drying Technologies
PepTalk: The Protein Science Week
January 13-19, 2014
This annual conference covers the latest trends and challenges in lyophilization, spray drying, foam drying and emerging drying technologies. It will feature in-depth case studies and discussion on developing a scientifically sound formulation, process optimization, vaccine and biologics freeze/thaw and formulation challenges, storage stability, strategies for scale-up from R&D to production, tech transfer, and selection of container/closure systems.
Join with colleagues from around the world in this discussion of the key challenges and solutions in lyophilization and other drying technologies, and see how experts like you are developing a scientifically sound formulation to deliver a safe and stable biologic drug product.
We invite presentation proposals on the following preliminary topics:
- Latest trends and challenges in development of scientifically sound formulation by lyophilization, spray drying, foam drying and other alternate drying technologies
- Lyo process development, optimization and key strategies for scale up, manufacturability assessment and technology transfer
- Controlled ice nucleation during freezing
- Models to predict freezing and drying behaviors
- Quality by design (QbD) and PAT in freeze drying: How can we develop a robust and efficient process?
- Regulatory considerations for lyophilized products and processes
- Optimizing freeze-dried protein formulations: Choice and influence of excipients and their composition, characterization of phase and thermal behavior, and cake structure
- Stability of proteins in freeze dried state: Impact of collapse on protein stability, and deterioration of lyophilized proteins upon storage
- Residual water content: Is drier better? How to control the residual water content
- How to measure local water content in partially crystalline materials?
- Effect of annealing on primary drying in freeze-drying and on foam stability in foam drying
- Particle size and its effect on spray dried protein formulations
- Thermal analysis and characterization of freeze-dried, spray-dried, and foam-fried formulations
- Integrating and validating isolators and auto-loading systems into your fill-finish operations
- Drying Techniques for novel and complex biologics: Case studies on Lyo and alternate drying techniques for micro/nanoparticle, and antibody-drug conjugates
- Novel methods to evaluate and eliminate protein aggregation in frozen or freeze drying cycles
- Case studies on incoherent inelastic neutron scattering technique, optical coherence tomography, isothermal calorimetry, solid state NMR, low temperature Raman, small angle X-ray scattering
- Delivery challenges: Cake properties, challenges and causes of slow reconstitution
- Strategic collaboration and partnership in biopharmaceutical development and manufacturing: Working effectively within the company and outside with vendors, CMOs and partners
Please click here to submit a speaking proposal for review.
Deadline for submission: June 7, 2013
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, 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
Email: dinerstein@healthtech.com