Cambridge Healthtech Institute’s 4th Annual

Process Characterization and Control

A best practices forum for the translation of process understanding into control strategies for maintaining quality throughout the product lifecycle

August 16-17, 2018


With the recent publication of process validation guidances from both US and European regulators, the demonstration of process understanding, identification of critical quality attributes and the implementation of well-validated control strategies must now become a routine part of biologics manufacturing operations. But significant ambiguities remain in the specific steps that must be taken in the production of legacy and new products, by companies of different scale and resources and for specific product formats. Process Characterization and Control offers a forum for the sharing of strategies and best practices from a wide range of industry companies working to implement these complex new standards.

Proposed presentations should offer case studies of strategies, best practices and technology solutions – and sharing of the rationale behind decisions associated with risk management and resource allocations related to process characterization, qualification and control.

Topics may include, but are not limited to:

Process Characterization

  • Attribute characterization strategies
  • Best practices for interface of analytical, manufacturing and process development roles in process characterization studies
  • High throughput methods and informatics for process characterization
  • Transitioning early HT process characterization to scale down models

Critical Quality Attributes and Specification Setting

  • Best practices for specification setting; regulatory expectations for specifications
  • Defining DS CPPs with limited historical process runs and limited datasets
  • Evolution of QbD approaches; what is working?
  • Specification development throughout the product lifecycle

Challenges in Process Characterization and Control

  • Optimizing operating ranges and design space to minimize phase 3 validation risk
  • Product quality issues in CMO/CRO relationships
  • Regulatory expectations for process understanding and design space; how these relate to specifications
  • Timing considerations in process qualification and validation

Online/Inline Process Monitoring

  • Challenges of implementing commercial stage inline process testing, monitoring and control
  • Emerging detectors and technologies for online/inline process monitoring
  • Inline monitoring and control in continuous manufacturing systems
  • In-process controls for allogeneic and autologous cell therapies

Control Strategies

  • Continuous process verification
  • Development and evaluation of control strategies; timing of control strategy development
  • ICH Q12; post approval change management
  • Impurity evaluation and control strategies

If you would like to submit a proposal to give a presentation, please click here. Please specify the conference in which you would like to speak and remember to provide your full contact information.

Deadline for priority consideration is February 9, 2018.

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

Senior Conference Director

Phone: 207-869-9199

Email: ksimmons@healthtech.com

For exhibit & sponsorship opportunities, please contact:

Companies A-K

Sherry Johnson

Business Development Manager

Phone: 781-972-1359

Email: sjohnson@healthtech.com

Companies L-Z

Carolyn Benton

Business Development Manager

Phone: 781-972-5412

Email: cbenton@healthtech.com

For media partnership opportunities, please contact:

Kaushik Chaudhuri

Director of Product Marketing

Phone: 781-972-5419

Email: kchaudhuri@healthtech.com