Cold-Chain & Logistical Challenges of Cell Therapeutics in Clinical Trials

Transcription

1 Cold-Chain & Logistical Challenges of Cell Therapeutics in Clinical Trials Dan O Donnell Associate Director, Cell Therapy Logistics Fisher BioServices Part of Thermo Fisher Scientific

2 Logistics of Biologics & Cell Therapeutics Scope The movement, processing and storage of biologic materials from the point of manufacture to administration in a patient Storage & Distribution Goal To create a scalable chain of custody solution that is 21 CFR part 11 compliant which documents the movement, the temperature and the handling of the material at all times and at all points in the logistics chain Collection Administration (time sensitive) An Example of Autologous Cell Therapy Process Flow 2

3 Product Movement in Clinical Trials Product Acquisition Receipt & Inventory Storage & Monitoring Distribution Transit Investigator Site E n d to E n d C h a i n o f C u s to d y S o l u t i o n s 3

4 Product Acquisition - Direct Specialized Truck & Device Product acquired via LN 2 equipped trucks Specialized roll-on, roll-off Chamber Cambers are monitored throughout acquisition & transport process Vehicle systems continually monitor and adjust temperature Temperature controlled to +/- 2 o C 4

5 Product Acquisition - Indirect Selection of Transport Vessel Transport packaging configuration Temperature monitoring Custom racking systems Ship Store Inventory Distribute Use of transport partners 5

6 Receipt and Inventory Management Material Management All materials should be handled internally utilizing fluke monitored cryo-cart Materials are entered into an inventory management system 21 CFR part 11 compliant system Scalable and customizable Chain of custody documentation Global web access system for stakeholders Technicians /Personnel Management Should perform operation under standardized SOPs and client specific work orders & requirements 6

7 Storage and Monitoring Vapor Phase LN 2 Storage Validated Quality assurance Redundant fully charged backup 21 CFR part 11 validated monitoring system Risk Abatement Programs Multiple vessels Multiple locations Controlled Access CC monitoring Restricted/managed access 7

8 Distribution Domestic and International Shipped via project specific dry shipper Custom transport racks Temperature monitored via Data Logger All Product transfers via Cryo Cart Harmonized distribution of collection, processing and administration kits 8

9 Transit - Domestic TSA Considerations X-Rays Examinations Dry Runs & Route Tests Dewar type Data Logger Carrier Air Freight Temperature Excursions Probe location Payload location Packing and baffling 9

10 Dry Shippers and the Venturi Effect Red Vs. Blue Line The Venturi Effect Air aspiration Temperature & pressure variations Dry shipper packout Desired 10

11 Transit Going Global Labeling Requirements by country Languages How many Translate and retranslate Qualified Persons Biological vs Chemical Pre-certification teleconference Investigative site storage Same as US Customs Requirements Declared value (Commercial Invoice) Brokers Reproducibility 11

12 Investigative Site Receipt and Storage Operating Procedures Product retrieval and storage Security measures & protocols On-Site LN 2 vapor freezers Turn-key set up Staff training Temperature monitoring On Site Off Site Manage LN 2 deliveries On-Site Preparation and Transport 12

13 Cell Therapy Logistics Summary Product Acquisition Receipt & Inventory Storage & Monitoring Distribution Transit Investigator Site E n d t o E n d C h a i n o f C u s t o d y S o l u t i o n s Vendors Partners Clinical Sponsor FDA 13

14 Case Study: Tumor Collections for Autologous CT Challenge: Autologous product requires tumor collection, storage, shipment to manufacturing facility, drug storage & distribution Solution: Specialized kits for each collection, qualified return shippers, harmonized ultra cold-chain storage and distribution Features: Tumor collection, plasmapheresis kits Ambient & refrigerated return shippers Standardized collection processes Validated cryogenic storage units Harmonized cell storage Harmonized distribution 14

15 Questions? Contact Us USA UK CH Follow us on LinkedIn Visit blog.fisherbioservices.com for ebooks & whitepapers 15