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23rd Technical Meeting
Digital Advances in Advanced Therapy Manufacture in Practice
The day will include a combination of specialised talks on this theme, a choice of workshops and a ‘fresh thoughts’ session. There will also be a number of opportunities for networking and discussions with vendors.
Registration and Networking
AMC Update including regional events
AMC Meeting Introduction
10:00 Session 1.
Practical Applications of Digitalisation chaired by Lucy Foley
- Digital transformation in R&D is the key to robust manufacturing processes, Monica Lopez Puerta, Oxford Biomedica
- Automating paper-based systems to ensure compliance and improve operational efficiency, Mike Clausen, Fujifilm DB
- A consortium investigation for the extensive monitoring and characterisation of T cell immunotherapy processes, Rhys Macown, CGTC
- Lonza, Ian Anderson
12.00 Session 2.
Data structure and traceability to enable paperless manufacture chaired by Mike Delahaye
- How does Autolomous solution support across the CGT value chain and accelerate the move to paperless manufacture? Kwok Pang, Autolomous
- Why data “sharing is really caring” for the ATMP ecosystem – Najib Rehman, ATMPs
14.00 Session 3.
Advances in enabling technologies chaired by Abby Clark
- Siemens, Eric Flynn, Philipp Doecke
- The Biocomputer; a software configurable platform for accelerating R&D to manufacturing – Clive Barker, BiologIC
- Adva, Naom Bercovich
- Industrialising manufacture of cell therapies through robotic and digital interconnection of devices. – Dan Strange, Cellular Origins
16.00 Session 4.
Supplier Quickfires and Fresh Thoughts chaired by Michael Whitaker
- Biomerieux, Christie Downing-Kay
- Thoughts on AI in bioprocessing, Adam Janvier, eXmoor Pharma
- CAR T cell therapy manufacturing: improving clinical outcomes by vector design – Roman Labbe, UCL
16.30 Session 5
Industry Panel – Digitalisation in the Pharma Sector chaired by Michael Whitaker
- ATMPs, Najib Rehman
- Sterling, Susan Daly
- DTG, Tim Gowling
- Biophorum, James Colley
Close & Dinner
Cell and Gene Therapy Catapult
The Cell and Gene Therapy Catapult is an independent innovation and technology organisation committed to the advancement of cell and gene therapies with a vision of a thriving industry delivering life changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector.
With over 400 experts covering all aspects of advanced therapies, it applies its unique capabilities and assets, collaborates with academia, industry and healthcare providers to develop new technology and innovation. The Cell and Gene Therapy Catapult works with Innovate UK. For more information, please visit either:
New diseases require new medications, and growing competition calls for faster, leaner processes in all areas of business in pharmaceutical companies.
Digitalizing pharmaceutical plants helps shorten market launch times and improve quality even more.
Siemens offers a comprehensive portfolio for the pharmaceutical industry that enables to combine the real and the digital worlds. We’re there to help you along the way. We’ll work with you to develop the ideal solutions for your specific requirements, combine your skills with our hardware and software portfolio, and help you digitalize your entire value chain.
Siemens Digital Solutions for the Pharmaceutical Industry
Optimal Industrial Technologies
Optimal Industrial Technologies has more than 30 years’ experience in the automation and optimisation of control and data management systems for the pharmaceutical, biotech and life science industries.
Our PAT Knowledge Management software platform, synTQ®, enables real-time process monitoring and the control of critical quality attributes, non-invasively, to facilitate Quality by Design (QbD) via Process Analytical Technology (PAT).
The demands being placed on manufacturers in relation to production costs, product quality and business sustainability are ever increasing. We strive to deliver measurable improvements in these target areas.
FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies is an industry-leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting the biopharmaceutical industry in the development and production of biologics, vaccines and advanced therapies.
Our focus is to combine technical leadership in process development and cGMP manufacturing supported by a strong team of over 4,000 employees and a reputation for excellent customer service. We are a trusted partner of many clients, from early stage biotechs to large pharma.
Watertown and Cambridge, MA
Research Triangle Park, NC
Holly Springs, NC, USA (coming in 2024)
College Station, TX
Thousand Oaks, CA
Key Service Areas:
· Cell Culture
· Microbial Fermentation
· Advanced Therapies
· Drug Product Manufacturing
· Finished Goods
· CMC Support Services
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.
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.
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.
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.
For those of you who are joining us for dinner, we are eating at d&a Zuid, Maasstraat 72
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- RT @eXmoorpharma : Huge thanks to the speakers at last month's @ATMPmanufacture amc conference, including Aoife Duffy, CCMI at @nuigalway , B… 4 years ago