Clear Allocation of Responsibilities Creates Safety
Patient-specific dendritic cell therapy requires coordinated collaboration between the treating practice or clinic, the coordinating network, the transport provider and the manufacturing laboratory.
Medical decisions remain with the responsible treatment team. The laboratory is responsible for manufacturing, quality control, release and product-specific instructions. IMMUMEDIC coordinates documents, appointments, logistics and communication.
Practice / Clinic
Medical assessment, blood collection, administration, monitoring and documentation.
GMP Laboratory
Manufacturing, quality control, release and product-specific storage and thawing instructions.
IMMUMEDIC
Organisation of collection kit, transport, scheduling, delivery and follow-up monitoring.
Preparing a New Case
- confirmed diagnosis and current pathology
- stage, metastases and current imaging
- previous and planned treatment measures
- current medication list, steroids and immunosuppressants
- current blood count and relevant organ values
- contact details and consent documents
Blood collection and pre-analytics
Blood collection is carried out according to the specified collection parameters. Tubes, volume, timing, labelling, temperature and transport time must be followed exactly. Deviations can affect the usability of the starting material.
Pre-analytics: Before collection, identity, case ID, tubes, accompanying documents, pickup time and contact person must be checked.
Transport to the laboratory
Transport is coordinated in time. The material must be handed over to the laboratory within the specified time window. Delays, incorrect storage or incomplete documents must be reported immediately.
Receipt of the frozen delivery
Check delivery
Check recipient, case ID, number of doses, packaging and accompanying documents.
Maintain Temperature
Store subsequent doses frozen immediately according to the laboratory instructions.
Document
Document time of receipt, condition of packaging and start of storage.
Report Deviations
Report temperature deviations, damaged packaging or unclear labelling immediately.
Storage
Storage must be carried out exclusively according to product-specific laboratory requirements. The practice or clinic must ensure that the temperature is maintained and documented and that only authorised personnel have access.
- suitable and monitored frozen-storage facility
- temperature monitoring and documentation
- clear identification of doses
- protection against accidental thawing or mix-ups
- emergency plan for technical failures
Thawing and preparation for administration
The respective dose is thawed only immediately before the scheduled appointment in accordance with the laboratory instructions. The often-mentioned thawing time of approximately 15 minutes applies only if confirmed by the specific accompanying documentation.
Administration and monitoring
Before use, identity, case ID, batch, release, storage record and current clinical condition are checked. Administration is performed by qualified medical staff and fully documented.
- verify patient identity and case ID
- check batch and expiry information
- assess current general condition and signs of infection
- document route, time and dose of administration
- observe and record immediate reactions
Required Documentation
| Document | Content |
|---|---|
| Treatment Documents | consent, medical history, diagnosis and treatment plan |
| Transport Record | pickup, handover and delivery |
| Storage Record | temperature, start time, deviations and release |
| Administration Record | batch, date, time, location, person and reactions |
| Follow-up Monitoring | blood count, immune status, tumour dynamics and clinical course |
Requirements for cooperation
- qualified medical personnel
- suitable premises and hygiene standards
- reliable availability and appointment organisation
- suitable frozen storage
- complete documentation
- willingness to communicate with the laboratory and coordination team
How cooperation starts
Initial Contact
Brief introduction to the practice or clinic and possible services.
Coordination
Clarification of rooms, staff, storage, appointments and responsibilities.
Dokumenty
Provision of the required procedures and document templates.
First Case
Joint planning and supported implementation of the first case.