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 9th Annual 
Lyophilization and Emerging Drying Technologies
Formulation Development, QbD, Process Optimization and
Delivery and Devices Challenges

January 19-20, 2016

The popular Lyophilization and Emerging Drying Technologies conference covers latest trends and challenges in lyophilization, spray drying, foam drying and emerging drying technologies. This conference features in-depth case studies, new and unpublished data and discussions on developing scientifically sound formulation, process optimization for biologics and vaccines. It also presents cutting-edge research and case studies on freeze/thaw and formulation challenges, drying in cartridges, storage stability, QbD approaches and strategies for scale-up from R&D scale to full production level, and selection of container closure systems. We are seeking cutting-edge research findings and unpublished data to be featured at this forum.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 in lyophilization and other drying technologies.

We invite presentation proposals on the following preliminary topics: 

  • Regulatory considerations, latest trends and challenges in formulation development for lyophilization, spray drying, foam drying, supercritical fluid drying, microwave drying and other alternate drying technologies

  •  Advances in lyophilization technology:
    • Controlled ice nucleation during freezing
    • Advances and application of high throughput and miniaturization techniques
    • Continuous manufacturing  of lyophilized pharmaceuticals
    • Impact of freezing and freeze thaw cycle on freeze-dried protein formulation

  • Quality by design (QbD) and PAT in freeze drying:
    • Case studies on development of robust and efficient processes
    • Process analytical technology such as TDLAS
    • Critical scale-up issues: Prediction of differences and impact on process design
    • Impact of variability and scale up on design space from lab to manufacturing  scale and technology transfer during all stages of development

  • Optimization of freeze-dried protein formulations:
    • Analytical tools and novel methods for studying protein aggregation and particles in lyophilized formulation
    • Choice and influence of excipients on stability and cake structure, models and tools to characterize cake structure, phase and thermal behavior and impact on protein stability, including impact of collapse on protein stability in process and during storage
    • Elegance issues: Impact on product quality and process economics. When to reject?

  • Device and delivery challenges:
    • Drying in cartridges, syringes and dual chamber syringes. Case studies on particles formation in prefilled syringes, combination products
    • Container closure system testing and integrity and impact of packaging on lyophilized products
    • Cake properties, challenges in slow reconstitution of high-concentration formulation
    • Drying of new biologics and complex drug delivery systems like nanoparticles, liposomes and emulsions, etc.

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
Email: dinerstein@healthtech.com