QbD > ATMP > Cell by Design

MASTER YOUR ATMP DEVELOPMENT PROCESS WITH CELL BY DESIGN®

ATMPS ARE REVOLUTIONIZING HEALTHCARE

Advanced Therapy Medicinal Products (ATMP) are a reality. They are revolutionizing healthcare by introducing highly effective treatments for various diseases and injuries.

Cell by Design® (CbD) helps you resolve the abundant challenges currently faced in the development and production of a new ATMP.

PUT QUALITY FIRST IN YOUR PROCESS DEVELOPMENT ROADMAP

Cell by Design® enables you to opt for a quality-focused ATMP development process by executing risk-based process assessments.

The insights guide science and data driven decisions to meet all predefined critical quality attributes of the ATMPs.

ENSURE A CLOSED AND AUTOMATED ATMP DEVELOPMENT PROCESS

Your ATMP success also depends on the manufacturability and scalability of your developed product and process.

Therefore, Cell by Design® takes these into account right from the start, to ensure a 100% closed and automated process. Based on the design space built by Cell by Design®, you can apply more affordable parametric product releases.

Process quality

Manufacturability

Scalability

GEAR UP WITH THE CLOUD-BASED CBD SOFTWARE PLATFORM

You will find the cloud-based CbD software platform very intuitive. Compatible with Industry 4.0 standards, Cell by Design® facilitates process automation and the use of machine learning methods and predictive modelling.

Make maximum use of the extensive process expertise contained within CbD. Follow a structured approach in developing new ATMPs which facilitate market authorization and introduction.

TARGET

Define end product specifications and critical attributes

MAP

Describe unit operations and identify risks

Control

Reduce traditional QC by applying novel technologies

PROVE

Gather data through efficient experiment campaigns

SERVICE TAILORED TO YOUR SPECIFIC NEEDS

The application of Cell by Design® can be tailored to your specific needs. It can range from a close collaboration (in which you have full access to the software and can count on specialists’ advice in process development and in regulatory challenges) to any particular support you need for your specific ATMP product to process.