20th Technical Meeting

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, analyse, and utilise 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, haematology, 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 3,500 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/

Pall Corporation can provide fully integrated bioprocessing solutions for gene therapy, from discovery through to commercialization; from upstream through to final filling; from initial design through to implementation.

With a range of solutions covering multiple virus types, and with production in either adherent or suspension processes, our extensive single-use portfolio can offer you the complete solution you need.

www.pall.com/en/biotech/gene-therapy.html

Cellular Highways, a TTP company, is developing a new generation of automated high-throughput, scalable cell sorting instruments for research, diagnostic and therapeutic applications.

Powered by VACS, a new microfluidic cell sorter technology, our instruments will reduce the cost and complexity of cell sorting and achieve far higher throughput than existing platforms, thus making cell sorting accessible to every laboratory as well as enabling new clinical applications.

Our first product, Highway1 is designed for GMP-compatible therapeutic cell sorting. Highway1 is now a beta prototype, and we are looking for testers with challenging needs. Please get in touch if you would like to be a beta tester!

www.cellularhighways.com

hello@cellularhighways.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

Directly impacting the product quality, the freeze/thaw process is critical for the cell and gene therapy industry.

At Barkey, our motto is “Human Warmth”:  for over 40 years, we have specialized in safe warming technologies for hospitals and labs.

Today, we offer the devices for the cGMP cell thawing and cell culture media warming needs of the cell and gene industry.

Found in the Novartis Kymriah manufacturing patent and widely written into the SOPs of large and small biotech and pharma, the Barkey plasmatherm provides safe and reliable dry thawing that is both GMP compliant (replacement for water bath) and has the regulatory clearance to thaw final products in the hospital by the patient bedside.

Responding the flexibility and standardization challenges of Process Development, Barkey plasmatherm follows one-fits-all approach and is used to thaw products filled in container systems of all shapes and sizes, including bags, bottles and vials.

The Barkey plasmatherm is registered worldwide, supporting global manufacturing strategies, multinational clinical trials and commercial phase of CGT products.

We ensure global services for our devices, including device qualification( IQ/OQ/PQ), and preventive maintenance.

The Barkey plasmatherm is

• US FDA 510(k) cleared
• cGMP compliant
• EN ISO 13485:2016 compliant

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en.barkey.de/medical-technology/

Established over 50 years ago in Switzerland, Infors HT works closely with scientists, engineers and industry experts to develop and provide incubator shakers, bioreactors and bioprocess control software for a wide field of applications.

Based in Reigate, Surrey (but present nationwide), Infors UK collaborates with customers to provide solutions which help and support efficient, reliable and reproducible cell and micro-organism cultivation, allowing the full potential of processes to be achieved.

Our solutions include:

• Microorganism fermentation: including bacteria, fungi and yeasts

• Cell culture fermentation: including mammalian, insect, plant and algal

• Shaking incubators for microbial cultures

• CO2 shaking incubators for mammalian cell cultures

• LED shaking incubators

• Biofuels: biodiesel and bioethanol

• Parallel bioprocesses

• Bioprocess control software

• Qualification of both bioreactors and shakers

In addition to our standard configurable products, Infors UK also offer bespoke custom-made bioreactors and shaking incubators upon request, as well as offering preventative maintenance, servicing and technical support.

Infors UK specialists have many years of experience working in the laboratory and as such, we can work with you to find the right solution for your needs and help bring life to your laboratory.

www.infors-ht.com/en/

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

BioDock is a state-of-the-art biological storage facility based in Nottingham, UK.

As one of the largest private stem cell banks in the UK, we hold an extensive range of accreditations and licences including: HTA, HFEA, APHA, GMO Class 1 and ISO9001. We are experts in providing bespoke solutions for an extensive range of clients and their requirements.

Our services include;

• Sample Storage
• Reagent Storage
• Biobanking Consultancy
• Contingency Planning and Disaster Recovery

We offer a range of storage conditions to accommodate a wide variety of biological materials. These include liquid nitrogen and vapour-phase nitrogen, -80°C, -20°C and controlled ambient storage. Each service is bespoke to each client and their samples to ensure they are stored in the optimal storage conditions.

Multiple storage sites are readily available for back up; all containing storage vessels which are monitored with a fully traceable (21 CFR Part 11) round-the-clock monitoring systems with experienced scientific officers on standby to handle any unexpected issues. Sample inventories are stored on a specialised system, allowing easy identification of samples for release; this system is also 21 CFR Part 11 compliant.

As well as sample storage in a range of conditions, we are also highly experienced in shipping and receiving samples from around the world in a range of temperatures. All materials are temperature-monitored throughout transport to ensure a continuous cold chain of data. Depending on the determined move plan, we either work with specialised courier services or use our own dedicated medical courier service to conduct the move.

For more information about Biodock and our services, simply email info@bio-dock.com or call us on 0115 907 8613 and one our cryostorage specialists will be in touch. BioDock is a trading name of Future Health Technologies Ltd

bio-dock.com

Telstar is a leading global brand of aseptic process solutions.

The company, part of the azbil Group, specializes in the development of engineering & construction projects, integrated process equipment and GMP consultancy solutions, including turnkey projects and critical installations, for companies associated with Life & Health Sciences (pharmaceutical & biotechnology, healthcare, cosmetic, veterinary, and food & beverage industries, hospitals, laboratories & research centers).

Telstar has a long track record and experience in the development of highly complex projects, from integrated process equipment to design, engineering and construction of complete turnkey pharmaceutical and biotech production facilities, critical installations, clean rooms, and R&D laboratories. Acknowledged as one of the 10 major suppliers for the pharmaceutical industry, Telstar is one of the few international manufacturers able to offer integrated process solutions for the biopharmaceutical industry with in-house sterilization, freeze drying, containment, process water & waste treatment, clean air, and cold storage technologies. Telstar invests 3% of its turnover in research, development and innovation of its technologies and equipment.

The company operates in over a hundred countries and has 4 production plants, 7 technology centres and 11 consultancy and engineering services centres, and commercial offices all over the world. It has manufacturing plants in Spain, China, and the United Kingdom. Headquartered in Terrassa (Barcelona, Spain), it has a workforce of 900 people.

Equipment and Systems – Technologies & Integrated Solutions
Design and manufacture of complete integrated equipment solutions in the process field through application of in-house technologies for sterilization, generation of water and pure steam, freeze-drying, containment, clean air, and cold storage.

Telstar specializes in the application of in-house technologies to the design and development of integrated process solutions which are to be implemented in existing facilities or to be integrated into new pharmaceutical or biotechnological plants or new research laboratories.

Services –Engineering, Construction & Consultancy
In the services field, Telstar provides high added-value solutions in consultancy, engineering and construction of pharmaceutical and biotechnology plants and complete laboratories for the manufacture of medicines, including critical equipment.

This encompasses validation, regulatory compliance and implementation services for logistics management and maintenance systems. Telstar takes on overall management of customized, integrated, innovative and effective turnkey projects, including consultancy, development, and end-to-end monitoring of projects.

Engineering
Design of integrated turnkey projects, from the technical feasibility study and definition of requirements, development of the basic and detailed engineering using the most advanced tools to ensure a top-quality result from the start of the project, right through to qualification, all overseen by a project management team of Telstar professionals who work closely with the client to offer support and advice in critical decision-making and ensure the ultimate success of the project.

Construction
Telstar makes available to the life sciences industrial sector its expertise and technological capability in the development of integrated critical and non-critical facilities and the construction of conventional and modular-concept pharmaceutical and biotechnology plants.

Telstar develops integrated turnkey plant and facilities construction projects for the pharmaceutical, biotechnology and veterinary industries, with a high degree of specialization in the design, supply, installation, qualification, and implementation of critical facilities for these industries.

GMP Consultancy
Telstar focused on strategic technology-based businesses and services and aimed at addressing regulatory compliance requirements in critical manufacturing processes in the life sciences field, ensuring efficiency, quality, and risk minimization at the same time as assured compliance to quality regulations and standards demanded by different national and international health authorities.

www.telstar.com

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