Apheresis Management

Scalable apheresis management systems to support your clinical and commercial programs.

Apheresis management

GMP apheresis management systems to support your cell therapy program

We understand that an optimized apheresis management system is essential to clinical trial recruitment and commercial program success.

We have over 18 years’ experience managing apheresis collections under GMP conditions applicable to worldwide programs. We have developed the clinical protocols, process controls, documentation, training, and quality systems to ensure apheresis collections meet Australian and global regulatory expectations.

Our Modular Process

Our approach is captured in 5 different modules and these can be implemented collectively or separately depending on the needs of the clients’ program.

1

Development

Establish the critical quality attributes desired from the starting material, clinical site, and patient processes

Draft collection protocol with defined acceptance criteria

Outline comparability requirement between sites

2

Documentation

Compose program procedures, manuals, and data protection protocols, with customization to ensure specific product requirements are captured

Draft quality and technical agreements

3

Site Selection

Establish site selection criteria

Conduct site audits and perform gap analysis to determine suitability

4

Site Establishment

Customize and localize documentation to integrate with site documents and perform training of personnel

Execute quality agreements

Supervise initial collection(s)

5

Monitoring

Logistics oversight of referral scheduling and shipping procedures

Remote deviation support

Performance tracking and analysis

Remediation of low performing sites

Contact the Cell Therapies Team today

Call Cell Therapies on +61 3 8559 7310 to talk to our expert team or enter your details below and we will contact you to arrange a call at a time that suits you.


Explore our services

Cell Therapies has extensive experience in the development and commercialization of cell and gene therapies for the Australian and global markets.

Contract Manufacturing

We provide rapid technology transfer, process development, manufacturing optimization, clinical trial and commercial product supply to global markets

Clinical Trial Support

We manufacture products for clinical trial, provide process development for programs, manage product storage, and supply logistics and distribution

Consulting and Advisory

Our experts advise on Chemistry, Manufacturing, and Control (CMC), Australian and international regulatory standards and requirements, and clinical program development