GMP Biorepository

Do you need to store your cell banks securely to AVOID ANY BREAKS IN YOUR MANUFACTURING CYCLES? Do you need to PRESERVE YOUR DRUG SUBSTANCE LOTS under stable conditions?

Cell&Co will store your cell banks and drug substance lots within its own infrastructure, independently of your production and fill & finish sites.

In close collaboration with your personnel and service providers, our team also manages the national and/or international movements of your raw materials and products, without delays and in strict compliance with regulatory constraints and cold chain requirements.

Delivered in line with GMP standards, our services comply with pharmaceutical regulatory requirements. They meet your risk management demands relating to pharmaceutical bioprocesses and are designed to safeguard your therapeutic innovations.

Main resources managed

Active ingredients/Drug substances
Master/Working/Research Cell Banks
Regulated sample libraries
Excipients

-196°C

-150°C

-80°C

-30°C

-20°C

+5°C

+15/+25°C

Benefits to you

Preserve your cell banks and drug substances long-term to GMP standard

Control your stocks using practices that comply with the demands of the health authorities

Safeguard the future value of your therapeutic innovations

Our expertise

Secure storage

Storage at two different sites in a GMP environment under strict surveillance

Raw material controls and handling conducted in line with validated processes that rigorously comply with cold chain requirements

Logistics

Comprehensive administration of national and international movements

Continuous selection and assessment of service providers

Processing of regulatory and customs formalities

IT solution

Remote administration of your products via our Biotracker™ software (FDA 21 CFR Part 11 compliant) providing a customizable user interface

Traceability at all stages of the product life cycle and reports adapted to your requirements

Innovative systems

Overwrapping system for optimum temperature stability and protection against the external environment

Sealing system guaranteeing that products have not been handled

Administrative and regulatory procedures

Drafting, submission, and monitoring of regulatory applications

GMO declaration

Authorization to store and distribute pharmaceutical raw materials

Testimonial

Cell&Co were recommended by one of our trusted service providers to provide GMP-compliant, secure, monitored facilities which would be able to store 50% of our cell banks under strict temperature conditions. Following a vendor audit, Cell&Co was selected for this service, which also included the provision of all regulatory documentation required for the import and storage of the materials, organising the logistics for the transfer and receipt of the materials under GMP conditions. The contractual process and high quality service were provided by Cell&Co’s friendly and responsive staff.

SCANCELL