Cambridge Healthtech Institute’s 3rd Annual
Overcoming Formulation Challenges for Biopharmaceuticals Development:
Formulation and Process Optimization, Analytics, Device Integration and New Biologics
August 3-4, 2015
Part of CHI's 7th Annual The Bioprocessing Summit
August 3-7, 2015 | Westin Copley Place Hotel | Boston, Massachusetts
The popular second annual Overcoming Formulation Challenges for Biopharmaceutical Development conference will cover latest trends and challenges in biologic formulations development, process optimization, manufacturing, and device and packaging considerations for existing and emerging protein therapeutics. We are seeking case studies, especially unpublished and innovative work, on the use of the effective scale up strategies, excipient induced instability, process challenges, fill finish challenges, and predictive tool for rapid formulation and stability screening.
We invite you to submit a proposal to speak, present a poster, or to attend to learn from and network with the leading experts from around the world in the field of biologics formulation development.
Topics may include, but are not limited to:
- Formulation strategies for solid, liquid and other dosage forms of biopharmaceuticals
- Specific case studies on challenges in formulation and manufacturability of vaccines, bispecific antibody, antibody drug conjugate (ADCs), fusion protein etc.
- Special considerations for Higher-Order Structure (HOS) analysis in formulation development
- Product characterization, comparability and correlation between early development studies and late stage development studies
- Predictive methods in early stage formulation development
- High throughput screening for early formulation development- new tools, automation, multi-functional instruments; Data analysis and data management
- Challenges in Fill- finish and manufacturing processes
- Quality by design (QbD) and PAT for drug product development: How can we develop a robust process?
- Challenges in scale up, technology transfer and manufacturing of clinical supplies
- Setting of limits of failure and acceptable ranges in formulation optimization
- Lyophilization, spray drying, crystallization and other bulk manufacturing techniques
- Product presentation and device engineering and its impact on formulation development and downstream manufacturing
- Excipient related formulation issues: Case studies on surfactant that cause protein degradation and aggregations, stability issues arising due to drug-excipient interactions
- Protein device combination: Formulation strategies for pre-filled syringes and drug-device combination products, addressing stability issues arising due drug-device interaction and packaging system
- Container closure integrity and extractable and leachable considerations
Scientists who wish to present their knowledge and expertise to their colleagues are asked to click here to submit an abstract. Remember to specify the conference that you are interested in and please provide your full contact information.
Deadline for submission is January 30, 2015.
All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference
program. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, 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 more details on the conference, please contact:
For exhibit & sponsorship opportunities, please contact:
Manager, Business Development
For media partnership opportunities, please contact:
Director of Product Marketing