Cell Therapy Services

Fisher BioServices understands the critical elements on the path to commercialization of your cell therapy product. We partner with you inevery stage of development from early phase trials through phase III, licensure, and global commercial distribution. Our customized solutionsare developed to create the worldwide infrastructure and standardizedprocesses needed to deliver your cell therapy products.

• Flexible Logistics Services - Whether shipping patient biologics to your manufacturing site, individual doses to an investigative site or bulk transport of your product from a CMO to a clinical site, we have the right world-wide, end-to-end cryogenic transport solutions.

• Chain of Custody - Know the status of your product with completemonitoring and documentation from manufacturer to patient administration.

• Turnkey Clinical Site Support - When next day shipments are not fastenough, we can ensure product integrity and seamless operations withon-site stocking programs. These programs include equipment, serviceand monitoring to allow sponsors and sites to have drugs requiring ULTor LN2 storage available 24/7/365.

• Ancillary Supply Kits - Be certain that your cell-based product isprocessed and administered consistently with custom-designed clinicalsupply kits containing all the ancillary supplies needed for administrationto patients.

• Biobanking - Master and working cell banks for cell-based therapiesand regenerative medicine are stored in secure facilities with 24/7/365monitoring and multiple redundant backup systems.

Unsurpassed Logistic Support

From production to administration, Fisher BioServices is the only organizationwith global infrastructure and logistical expertise to manage the regulatorycompliant distribution of cryopreserved cell-based therapeutic drugs. We have extensive experience in transportation of cell therapy products, cellbanks, and biologics in the U.S. and throughout the world.

• Global Cryogenic Cold Chain Management - Proven global capabilitiesfor the management of tissue and cell-based therapies.

• Worldwide Logistics - Ensure that your cell-based therapy materialsclear customs and arrive at clinical sites safely and expeditiously withIATA-compliant same day, next day, and weekend shipping and receiving.

• TSA Certification - For domestic shipments no additional x-ray or inspection is required, greatly reducing the risk of compromising yourcells and biologics.

• IT Systems - Be certain that your materials and data are secure at each point in the logistics chain and that the chain of custody is clearlydocumented with our proprietary, validated, 21 CFR Part 11 compliantIN-TRAK® Inventory Management System for 24/7/365 tracking, reporting, and audit trails. Access inventory and data at all times via our secure web portal.

Innovative Solutions

Regulatory ComplianceMeets regulatory requirements to handle and distribute cell-based therapeutics for clinical trials and commercial use worldwide

P cGMP, cGLP, cGTP, TSA, and MHRA compliant

P FDA registered HCT/P establishment

P Employees are regularly trained to ensure compliance especially for clinical trial support

Shipping and Transport

Experts in LN2 shipping, equipped to providestorage and cold chain transportation for the entire spectrum of cell-based therapies and regenerative medicine worldwide

P Custom LN2-equipped vehicles

P Fleet of qualified LN2 dry shippers 10 to 20,000 vial capacity

P Cryo Carts for best practice in-facility handling

Processes and personnel to ensure the integrityand security of your biologics during transport

P Adherence to PDA guidelines for coldchain transport of bulk material includingactive pharmaceutical ingredient

P Transit temperature alert and monitoringsystem

P Packaging qualified and validated

P Expert staff to perform packaging andtransit studies

P Personnel trained in IATA, DOT, and TSA requirements

301.315.846014665 Rothgeb Drive

Rockville, MD 20850 USAwww.FisherBioServices.com

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Kits and Clinical Supply SolutionsOur kit production & distribution services let you focus on clinical trials rather than managing kits and supplies. To maximize the value of your clinical trial, we will help you design project-specific kits for thepre-manufacture collection of biological samples, investigative sitepreparation and subject administration as well as post- administrationsample collection.

We are experienced in the design and assembly of kits requiring pharmaceutical products, temperature-sensitive materials, procedure-specific surgical components, product-specific preparationcomponents, and patient-specific administration components. IATA-compliant return packaging and air bills can be readily assembled.

Other features include:

• Design and application of bar-coded labels

• Over-labeling

• Just-in-time kit production

• Online ordering of kits and supplies including clinical and non-clinical bulk supplies

• Randomization and blinding

• Network of collection options including in-clinic or in-home collections

Whenever possible, we leverage our sister companies within ThermoFisher Scientific to reduce lead times, ensure quality, and facilitateyour drug product development.

Quality Systems and Validation Services• Ensure that your on-site equipment for cell-based therapies meetsand exceeds strict standards of quality with our validation services.Validation protocols including IQ, OQ, and PQ are designed and executed to ensure compliance with FDA requirements and guidancedocuments and with quality standards established by the PDA.

• Be confident when shipping cell-based therapy materials. Our in-house metrology team can perform shipment pack-out and duration qualification studies on your packaging.

• For European clinical trials of investigational medicinal products(IMP) manufactured in the US, we will help design your trial and prepare QP Declaration for inclusion in submissions to the Europeanauthorities.

Global CapabilitiesOur multinational facilities and affiliated sites provide the global infrastructure and services needed for cell therapy products.

• Worldwide capacity with locations in Maryland, Pennsylvania, Massachusetts, California, the United Kingdom, Switzerland, India,Singapore, China, and South Africa

• More than 20 depots in Central and South America, Western and Eastern Europe, Asia, and Australia

Fisher BioServices has unparalleled infrastructureand experience to meet the logistical requirementsof companies with cell therapy products in development or commercialization.

From manufacturer to administration, we havethe end-to-end expertise and products for celltherapy management.

Please contact us to discuss your upcoming project at: Info.FisherBioServices@ThermoFisher.com.

Learn More About Our Solutions

High Value Biologics Storage

• Facilities monitored 24/7/365; controlled access and CCTV monitoring

• Emergency generators back up total systeminfrastructure

• In place, pre-conditioned back-up storage capacity available for all temperature ranges

• Temperatures monitored and logged continuously on all equipment

Temperature Options

P Controlled ambient

P 2 °C to 8 °C refrigerated

P -20 °C to -80 °C frozen

P -135 °C to -196 °C LN2

Equipment

P Walk-in refrigerators & freezers

P Upright refrigerators & freezers

P LN2 liquid & vapor phase storage

P Cryo Carts