22nd Technical Meeting

Sartorius CellGenix is a leading global supplier of high quality raw materials for the expanding cell and gene therapy space.

We develop, manufacture and market human cytokines and growth factors along with GMP serum-free media. Our products are used by academia and industry partners in clinical trials and commercial manufacturing throughout the world. To allow for a seamless transition from preclinical development to the clinical stage we offer our human cytokines and growth factors in preclinical and GMP quality.

With 25 years of experience, we are experts in the GMP manufacturing of raw materials for the cell and gene therapy space. As a former ATMP developer and manufacturer we gained in-depth cell culture knowledge and superior regulatory expertise. With this unique background we understand the high requirements our customers face during product development and the regulatory approval process. By offering expert technical and regulatory support we can help simplify raw material qualification and validation efforts.

We operate a state-of-the-art GMP facility for production of recombinant proteins and cell processing in Freiburg, Germany. Since 2021 we are part of Sartorius. Together with Sartorius we plan to expand our GMP facility and establish it as a center of excellence for the development and manufacture of critical high quality raw materials for the cell and gene therapy market.

Safe │ GMP Compliant │Reliable

www.cellgenix.com

Cryoport Systems is a market leader in globally integrated temperature-controlled supply chain support for critical, irreplaceable products and materials in the life sciences industry. 

We are already trusted to support over 600 active clinical trials and leading commercial products worldwide – delivering unparalleled, integrated supply chain services for products, therapies and treatments requiring unique, specialized temperature-controlled management. And, as the life sciences constantly evolve and advance, so do we.

cryoport.com

Miltenyi Biotec is a global provider of products and services that empower biomedical discovery and advance cellular therapy.

Our innovative tools support research at every level, from basic research to translational research to clinical application. This integrated portfolio enables scientists and clinicians to obtain, analyze, and utilize the cell. Our technologies offer solutions for cellular research, cell therapy, and cell manufacturing. Our more than 30 years of expertise spans research areas including immunology, stem cell biology, neuroscience, cancer, hematology, and graft engineering.

In our commitment to the scientific community, we also offer comprehensive scientific support, consultation, and expert training. Today, Miltenyi Biotec has more than 4,500 employees in 28 countries – all dedicated to helping researchers and clinicians around the world make a greater impact on science and health.

www.miltenyibiotec.com/

To protect patients, provide safe products and minimise vein to vein time, cutting-edge cellular therapies need state-of-the-art quality control solutions.

bioMérieux’s proven portfolio of microbiology testing solutions enable sites to carry out tests throughout each stage of the production process. bioMérieux provides solutions adapted for the unique set of requirements for testing ATMP’s. Testing for final products but, also at-line and in-process controls to relieve potential process bottle necks. Helping to maintain regulatory compliance and optimize operations for the future. These include:

• BACT/ALERT 3D DUAL T: Compendial, rapid and automated sterility testing. Ideally suited for testing turbid, short shelf-life intermediates and final products and reduced vein to vein time.
• BIOFIRE MYCOPLASMA: A 1 hour test that can be performed at-line, if required. This test can be used for release testing or testing starting materials, culture media and other in-process controls.
• ENDOZYME II GO SINGLE TEST: An animal-free endotoxin test with in-build controls designed for single or low volume testing.
• 3P Solutions: This range includes irradiated, plates for environmental monitoring, the AIR IDEAL, active air monitoring system and 3P Software for managing EM campaign in classified areas
• Accellix: A sister company providing rapid, automated cell attribute testing using innovative flow cytometry technology.

This is just a snapshot of some of our range, please come and visit our stand to learn more about these and other bioMérieux solutions.

www.biomerieux-industry.com/pharma-healthcare/market/advanced-and-cellular-therapies

Pharmagraph was formed specifically to meet the needs of clients seeking GMP/GAMP compliant solutions for their facility and environmental monitoring requirements, whether in small hospital pharmacies or pharmaceutical production facilities.

The parent company, Acquisition Systems Ltd, has been supplying systems to the pharmaceutical industry since 1992 and formed Pharmagraph in 2001 to focus on pharmaceutical and life science applications.

Pharmagraph systems measure temperature, relative humidity, pressure, air velocity, various gas types and particle counts, and deliver accurate, clear and secure results. From supply of sensors, through to installation, system qualification, training and calibration. Pharmagraph brings 30 years of experience to its customers, offering support at every stage to ensure that systems are delivered on time and to specification. The company offers complete 21 CFR part 11 compliant solutions for cleanroom and facility monitoring systems.

The Pharmagraph head office is based in Berkshire, UK, with a Northern office in Runcorn and further regional offices servicing the Scottish and Irish markets from Stirling and Lisburn respectively.

www.pharmagraph.co.uk

Aseptic Technologies manufactures innovative aseptic production equipment, designed to provide safer & easier aseptic filling operations.

The AT-Closed Vial® is provided ready to fill with its stopper secured in place, and sterilized by gamma irradiation. The filling is performed by a special needle piercing the stopper, which is then immediately heat-resealed by laser and capped. The drug product is thus never in contact with the environment. The AT-Closed Vial® ensures uncompromised Container Closure Integrity at -80°C and in vpLN2.

aseptictech.com