The Bioprocessing Summit
The Bioprocessing Summit

Cambridge Healthtech Institute’s 4th Annual
Early Analytical Development for Biotherapeutics
Optimizing the Selection and Performance of Preclinical Analytical Studies
Part of CHI's 8th Annual The Bioprocessing Summit

August 17-18, 2016 | Westin Boston Waterfront | Boston, Massachusetts

The analytical steps conducted in preclinical development following the handoff of a lead candidate are vital on many levels in determining the fate of that program. This complex effort shapes the optimization of the new product, requires the use of expensive and scarce resources and supports the voluminous regulatory filing that is the early IND application. It is imperative that companies reach this important milestone as quickly and efficiently as possible, while positioning the organization to move rapidly into the GMP production needed for early phase clinical trials. Early Analytical Development for Biotherapeutics will present best practice case studies of how industry companies have approached the most important analytical studies occurring during this stage, focusing on the development and optimization of key assays, the application of automation and the challenges of analytical development for novel modalities.

Proposed presentations should focus on case studies of lessons learned in preclinical development, and special consideration will be given to those addressing next generation biotherapeutic formats.

Topics may include, but are not limited to:

Early Analytical Assessments

  • Assays for developability evaluation and candidate selection
  • Benefits and limitations of predictive modeling in early development
  • Correlation of early predictive assays and long term outcomes
  • Platformed methods to support early portfolios
  • Strategies for accelerating preclinical analytical development

Assay Development and Implementation

  • Applications of mass spectrometry in early development
  • Assay development for characterizing effector functions
  • Emerging methods for early analysis of charge variants
  • Particle sizing and characterization
  • Troubleshooting identity, potency, purity and safety/immunogenicity assays

Analytical Development for Emerging Biotherapeutics

  • Antibody-drug conjugates
  • CAR-Ts and other cell-based therapies
  • Combinations and co-formulations
  • Peptibodies and fusion proteins
  • Peptide therapeutics

Other Early Analytical Challenges

  • Application of DOE to optimize product and process parameters
  • Automation and high throughput analysis in early development
  • Challenges of specification setting in early development
  • Characterization of biosimilar reference products
  • Developing functional cell-based assays without full knowledge of MOA

Please click here to submit an abstract. Please specify the conference in which you would like to speak and remember to provide your full contact information.

Deadline for submission is February 15, 2016.

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:

Kent Simmons
Conference Director
Cambridge Healthtech Institute
Phone: 207-869-9199

For exhibit & sponsorship opportunities, please contact:

Companies A-K

Sherry Johnson
Business Development Manager
781-972-1359 |

Companies L-Z

Carolyn Benton
Business Development Manager
781-972-5412 |

For media partnership opportunities, please contact:

Kaushik Chaudhuri
Director of Product Marketing
Phone: 781-972-5419