Consulting

PCT offers guidance for every stage of your process, from understanding and defining your product’s attributes all the way through commercial-stage manufacturing. We can build a roadmap for your therapy that will help you avoid obstacles and accelerate progress towards successful commercialization. By offering our clients consultative services that are founded upon a Development by Design approach, we can be your go-to partner for the entire journey of your cell therapy.

PCT offers several consulting services to help build and establish a long-term vision with commercialization in mind.

Consulting Options

Quality Risk Assessment

A Quality Risk Assessment (QRA) from PCT helps you identify potential risks in a product’s assay profile, including safety, identity, purity and potency. The QRA also provides assay development recommendations and validation plans.

Strategic Manufacturing Assessment

At its core, the Strategic Manufacturing Assessment (SMA) is an independent, disciplined, and diagnostic evaluation of a cell therapy process that can be completed in six to eight weeks.

Strategic Commercial Manufacturing Plan

The Strategic Commercial Manufacturing Plan (SCMP) is a robust plan that includes and exceeds the content of the Strategic Manufacturing Assessment and Quality Risk Analysis.

In addition to these three offerings, PCT can customize consultative services and personalized guidance for process optimization based on the size, scope, and clinical stage of any client’s cell therapy product. Some areas in which we can work with clients include:

 

Manufacturing Development

  • Process development,and scale-up
  • Product characterization, product and product stability
  • Product shipping validation
  • Analytical method development

Regulatory Services

  • Product development strategy
  • Master File development
  • Investigational New Drug (IND) applications
  • Pre-clinical study design
  • Chemistry,Manufacturing and Controls (CMC) development
  • Biologic License Applications (BLA)
  • Preparation/representation at regulatory meetings
  • Regulatory submissions, amendments, supplements and reports

 

Business Development and Commercialization

  • Strategic development
  • Financial modeling
  • Project management
  • Technology evaluation and licensing opportunities
 
Silky Kamdar, PhD, Scientist, Process Development
PhD, Neuroscience and Cell Biology, Rutgers University, NJ
 
Silky has served as a subject matter expert for quality and manufacturing for client process development projects. Her experience in cell and molecular biology comes from her more than eight combined years of post-baccalaureate and pre-doctoral training. Silky is responsible for process development as well as development and validation of assays that demonstrate integrity and function of cell therapy products, and contributes to the development of Strategic Manufacturing Assessments for clients.

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Speak to an Expert