Method Development, Qualification & Validation

Developing Fit-for-Purpose Methods throughout Product Lifecycle

March 20-21, 2017 |Hyatt Regency | Bethesda, MD


Method development qualification and validation is a critical component in all stages of drug development from preclinical to commercial manufacturing. With an expanded portfolio of newer formats and non-mAbs in the pipelines, knowledge, experience and advanced techniques are critical to establish efficient, accurate and robust analytical methods that can be validated and transferrable, as well as to ensure that the methods are fit for their intended purpose, and will meet regulatory requirements at different phases of a product’s lifecycle.

The Inaugural Method Development, Qualification & Validation conference invites scientists with experience in developing, qualifying and validating methods for new and challenging molecules to share case studies and discuss practical solutions on:

  • Strategies for method development and qualification
    • Leveraging platform method without over-developing
    • Streamline universal methods/approaches across programs
    • Generic vs product-specific method
  • Bottlenecks and challenges in method development and qualification for
    • Novel formats including bispecifics, ADCs
    • Non-mAbs, including gene therapy, fusion proteins and glycosylated proteins etc.
    • Bioassays
    • High variability in instruments and tools
  • How to
    • Decide which methods to use?
    • Which quality attributes are critical?
    • Set acceptance criteria?
    • Determine fit-for-purpose?
    • Develop and ensure a robust method?
    • Develop a high throughput and low volume sample method
  • Validation and transfer
    • Validation guidelines for analytical methods – expectations and requirements
    • Difference between qualification and validation
    • Protocol for late-stage tech transfer
  • Regulatory perspective on method development, qualification and validation
    • Different interpretations – different standards/procedures in different countries
  • Method lifecycle
    • How will better, more sensitive methods affect the original product’s specifications?
    • How do you deal with the changes?
    • How do you adapt your methods at different phases of a product?
    • Method lifecycle as a cyclical process – to revisit and adjust the method on a continuous basis
  • Applying QbD and DOE to analytical method development
  • Using math modeling/simulation methods to design qualifiable methods

If you would like to submit a proposal to give a presentation at this meeting, please click here.

The deadline for submission is August 26, 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:
Mimi Langley
Senior Conference Director
Cambridge Healthtech Institute
Phone: 781.972.5439
Email: mlangley@healthtech.com

For partnering and sponsorship information, please contact:
Jason Gerardi (Companies A-K)
Manager, Business Development
Cambridge Healthtech Institute
T: 781.972.5452
E: jgerardi@healthtech.com

Carol Dinerstein (Companies L-Z)
Director, Business Development
Cambridge Healthtech Institute
T: 781.972.5471
E: dinerstein@healthtech.com

Register Today!

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“Great talks from academia/university personnel with reviews of the literature.”
- Professor, University of Manitoba

“Very intimate setting; insightful presentations. A great way to get perspective of the field!”
- Scientist, Janssen