SOLUTIONS & LOGISTICS
Our expertise and knowledge is to obtain and deliver a comprehensive range of qualified cell collection processes in healthy donors and in patients in clinical studies of all phases. We have extensive experience in the collection of leukapheresis concentrates and the enrichment of leukocyte subtypes.
In addition, we offer consulting services in the fields of GCP and GMP, quality assurance and quality control systems in accordance with EU regulations.
Cyto-care.eu has established and validated shipping logistics. We are able to ship our fresh leukopaks on an overnight basis during business and off-business hours throughout Europe by using our specially trained courier service. For flights, we can work with your preferred courier. Our cell products are packed according to IATA regulations. Transport boxes are validated for a cell transport up to 72 hours at temperatures of 4-10 °C. All our boxes are supplied with a data logger for continuous temperature monitoring.
The term “cell therapy” covers various therapeutic treatments which have in common the use of human cells. The regulation of this type of therapy are covered in the section “advanced therapy medicinal products” (ATMP) of the EMA (European Medicines Agency).
The objective of a leukapheresis is to obtain leucocytes which are a substantial part of the human immune system and to use these cells for research and manufacturing of cell therapies.
The general principle of a treatment involving cell therapy is to activate the body’s immune system against pathogens or tumor cells, using the patient’s own white blood cells (leucocytes) after modification in a laboratory.
Cells from donors will be used for research and processes only.
For more information about EMA on advanced therapy medicinal products click on this Link.
Personalized medicine, that means treatments made for an individual patient, is currently a supplement to standard cancer treatments, such as surgery, radiation or chemotherapy.
Cell therapy, for example a therapy involving dendritic cells or for the production of CAR-T, is carried out in a series of steps:
- An assessment of the prospects of success of the cell therapy is made by the responsible hematologist/oncologist. Factors which might influence the success involve the individual disease pattern/clinical picture/symptoms and the individual disease progression
- Collection of cells from the patient
- Processing of wide blood cells in an accredited laboratory
- Re-transfusion of the treated defense cells
- Evaluation of the success of the treatment by the oncologist overseeing the whole treatment plan
Cyto-Care fulfils all national and international standards for the collection of blood cells to provide the necessary starting material for an individual cell therapy.
For the convenience of you and your relatives during consultations and donations treatments, we guarantee expertise, sensitivity and dedication offered by our entire team ensure that all treatment procedures run smoothly. Our multilingual team (German, English and French) provides you with an individual service customized to your needs during your stay at Cyto-Care.
Please note: It is the specialist physician together with the patient, who will decide whether cellular therapy is a suitable treatment option for the individual disease. For this reason, Cyto-Care only undertakes cell collection in connection with a referral from a hematologist/oncologist.
Further information on the cell harvesting process can be found in the section Cells & Products.
HEALTHY DONOR LEUKAPHERESIS FOR RESEARCH & DEVELOPMENT
- R&D, Cell assays, validation runs, trainings
- Private and academic research institutions, CMOs, small, mid and big pharma companies, biotechnology
- Repeat donations possible, special products
- „Fine tuning“ according to needs
- Consistently high cell counts and high quality
- Detailed release certificate
- Documentation of cell counts
- Testing of IDMs, additional testings possible (COVID, CMV))
- Collection according to transport logistics
- > 500 donors on file, allows the pre-selection of specific donor groups
- Leukapheresis is only performed on healthy human donors who have been thoroughly and extensively informed and have consented.
FOR MEDICAL SPECIALISTS
Individual cell therapies, for example a dendritic cell therapy (DC therapy) or a CAR-T therapy offer patients and oncologists additional treatment possibilities. Especially the CAR-T therapy has improved TTP and OS in B-ALL and certain NHL such as DLBCL or mantle cell carcinoma.
We at Cyto-Care work on the research end of the development of cellular therapies. We support only scientifically established procedures solely in cooperation with the medical community.
Outside of authorized clinical studies, we conduct cell collection only by formal referral by hematologists / oncologists.
Please do not hesitate to contact us for any further information.
OUR QUALITY MANAGEMENT
Our cell collection facility fulfils the highest national and international quality standards and is regularly inspected by the Austrian health authorities (AGES).
The Austrian Ministry of Health certified that our facility complies with all European regulations and GMP standards.
Since 2009 we fulfill all European GMP requirements in compliance with art. 111(5), Directive 2001/83/EC.
All of our blood products are labeled according to the ISBT-128 coding system and SEC. Additional labelling of our products with other standard bar codes is also possible.
Our suppliers and external service providers have been carefully selected, fulfill the GMP or other international standards, and are regularly monitored and evaluated to guarantee the highest possible quality of service.