PROCESS is Key : Cellprocess Platform is the Solution

Cellprocess Platform : the Origin

Developing a Process from R&D-grade to clinical manufacture is not an easy task, it’s not only a technical matter.

Before spending significant ressources, it is critical to understand how to meet the relevant regulatory requirements.

 

Our experienced process development and manufacturing teams are experts at determining customers’ critical needs and optimizing efforts to deliver a cost-effective, custom process tailored to industrial manufacturing.

INDUSTRIALIZATION

COST-EFFECTIVE

TIME-SAVING

As a Drug Developer, you are the expert of your specific ATMP Process.

 

As a valuable CDMO player, we are the right Partner to optimize critical aspects of your process, resulting in cost saving and more reliable products for patients.

PROCESS at a glance

 

 

Drug Development Phase

Discovery
Pre-Clinic
Clinic Phase I, II, III

Regulatory Compliance

ANSM
EMA
FDA
PFDA

Time to Market

GANTT Chart Optimization

Product Design

Adherent Cells : iPS cells, MSCs,… Non-Adherent Cells : Leukocytes, Engineered cells (CAR-T, CAR-NK, CAR-Treg…) ExtraVesicules : Exosomes…

Process Services

Process Review
Process Design
Process Transfer
Process Validation

Scalability

Scale-Out
Scale-Up
Automation

Cost drivers

Raw material
Manufacturing
Dose

Raw material

Hospital / Clinic contract
Tissue sourcing
Cell line handling

UpStream Process 1 Technology

2D culture
Bed-fixed
Hollow Fiber
3D _microcarrier

UpStream Process 2 Protocol

Standard
Chemical priming
Genetic priming

DownStream Process

Isolation
Harvesting
Washing
Filtration
Concentration
Formulation
Cryoconservation

Process limits

Critical Attributes (CQA & CMA)
Process Parameters (CPP & KPP)
Design Space

Data Acquisition

QbD_Quality by Design Approach
PAT_Process Analytical Technology Approach
Digitalization Approach

Data Analysis

Unimodal Data
Multimodal Data
Data minig

Analytical-base Approach

Cellnature
Cellsecure
Cellfeature

Contact

  • Tel : +33 534 276 550
  • Address : Cell-Easy SAS, 4 bis avenue Hubert Curien, 31100 Toulouse, France
  • Mail : info@cell-easy.com
European leading CDMO company specialized in large volume industrialized production of GMP approved cell products