Communiqué de presse :

CREAPHARM BIOSERVICES Since 2020, the partner of choice for Pharma, Biotech and Institutionnal players providing highly-secure biobanking & biorepository solutions from ambient to -196°C.

NITROGEN TANKS -80°C FOR HIGHLYSECURE STORAGE, A FIRST IN FRANCE.

CREAPHARM BIOSERVICES announces its investment in -80°C nitrogen tanks to provide the European ultra-low temperature storage market with unparalleled performance.

Always make cold storage more secure for products that need it.

While many biological products have to be stored at negative temperatures, some of them require ultra-low temperature storage conditions, from -80°C to -196°C. As a leader in cryopreservation, CREAPHARM BIOSERVICES has been offering both cryogenic storage at -196°C and storage in mechanical freezers at -80°C for 2 years. These highly-secure storage services meet the needs of research institutes, biotech companies and pharmaceutical laboratories. However, with the growth of research and commercial activities focused on innovative technologies such as new therapies (i.e. immunotherapies, genetherapies), the specifications and need for ultra-cold are still evolving.

« CREAPHARM BIOSERVICES is going to provide its customers with a unique offer for storing their high-value biological products at -80°C: the suitable option between the innovative technology of nitrogen tank or the mechanical freezer. Each technology has its own benefit and our experts are here to help customers choose the best solution for their needs. »
Frédéric MALBOZE, Director of CREAPHARM BIOSERVICES

MVE Vario -80°C Nitrogen Tank

• Consistent temperature profile
  – Unaffected by lid openings
  – No recovery time needed
• Completely dry storage area : cross-contamination minimized
• Storage density

Consistent temperature & hold time safety margin Storage of viral vectors, antibodies and other proteins can require stable low storage temperatures.
When the door of a mechanical freezer is opened, the temperature increases suddenly, and can quickly reach a critical point for the product, i.e. -60°C. Furthermore, it can take a substantial amount of time for the temperature to recover to -80°C once the door is closed. The innovative technology of the MVE Vario tanks solves this dilemma. The tanks are designed to negate the temperature exposure of lid openings so that no recovery time is required. In case of failure (LN2 supply depleted), it takes 2-4 days (will be confirmed and refined during qualification) when storing at -80°C for the chamber temperature to cross -60°C. Thus the risk of product impact is substantially reduced. As this new nitrogen tank offers completely dry storage at -80°C, cross-contamination is minimized.

CREAPHARM BIOSERVICES’ existing facilities and expertise

CREAPHARM BIOSERVICES is setting up two nitrogen tanks at -80°C thanks to its deep expertise in nitrogen storage management. The warehouse in Bailly-Romainvilliers (77), already dedicated to ultra-secure storages, has welcomed these 2 new innovative equipments within those already in place.

AN UNPARALLELED STRUCTURE

• A state-of-the-art plant, compliant with GMP requirements & a single platform by its wide capacity and its security level
• The first French private biobank (Centre of Biological Resources) certified ISO 9001, ISO 20387 & NF S96-900
• The first cryopreservation establishment that has been authorized by the French Public Health Agency (ANSM) for the storage of cell & tissue therapy under Article L.1243-2 of French Public Health Code (CSP) and in compliance with good practices. (LinBox site in Bailly Romainvilliers –
  77)

Final steps

The equipments received will be decontaminated, installed in the dedicated warehouse and then qualified.
By June 2022, everything will be ready to store the first samples in nitrogen tanks at -80°C.

« We are going to deploy our in-depth qualification protocol (IQ, OQ, PQ) including in particular decontamination and temperature mapping in order to guarantee the performance of this new technology which aim tomeet the storage needs of the most precious products. »
Marine THIEBAUD, Head of Quality & Regulatory and Ludivine MIOSSEC, Chief Operating Officer

#1challenge1solution

CREAPHARM’s leitmotiv is to provide its customers with a tailor-made solution, based on our newly available options. In a few weeks, companies looking for a solution to store their high-value biological products at -80°C will have the choice between the mechanical freezer and the nitrogen tank technologies. Each technology has its own advantage and CREAPHARM BIOSERVICES experts guide their customers to select the best solution for their needs based on several factors like samples category & volume to be stored, temperature stability requirement, storage duration and access to nitrogen.

CREAPHARM BIOSERVICES IS PART OF CREAPHARM GROUP

Partnering with CREAPHARM, Pharmas & Biotechs benefit from an expert support from the preclinical/clinical development to the market launch for Biobanking, Clinical supplies management and Contract packaging CREAPHARM BIOSERVICES provides Biospecimen Management, Biobanking solutions (ambient to -196°C) and Training, Consulting & Audits. CREAPHARM CLINICAL SUPPLIES/CREAPHARM INDUSTRY manage Packaging of both investigational and marketed health products. Partners entrust CREAPHARM for its worldwide logistics and cold-chain
management in clinical trials.

One challenge, one solution
The Project Management team provides health players with tailor-made services.
Quality, our common priority
With a 30-years experience and 5 state-of-the-art plants, CREAPHARM offers a
unique service. In compliance with GMP/GDP & biobanking standards and
proven processes, every project is handled with Quality as a top-priority.

Global Capability, Local Specialists
Settled in France and the USA, CREAPHARM has 40 partner depots worldwide.

High value-added pharmaceutical support
The CREAPHARM’s pharmacists manage EU QP-release, even for the mostinnovative drugs.