Connecting Pharmaceutical Knowledge
2018 ISPE Biopharmaceutical Manufacturing Conference
Continuous, CAR-T, & Oligo - Are You Ready for the Future of Biologics Manufacturing?
The 2018 ISPE Biopharmaceutical Manufacturing Conference focuses on the quickly evolving science of biologics manufacturing for new modalities. From leveraging existing capacity with novel processes, to implementing new and emerging technologies, this conference will bring together experts and leaders to ensure the Biomanufacturing industry successfully prepares to manufacture these novel medicines to deliver on our promise of supplying life changing medicines to patients across the globe.
Join us in December in beautiful Huntington Beach, CA to discover more about these aspects of Biopharmaceutical Manufacturing.
Conference Highlights
Continuous, CAR-T, & Oligo – Are You Ready for the Future of Biologics Manufacturing?
3 December 2018 - This year’s ISPE Biopharmaceutical Manufacturing Conference promises to deliver excellent content and is a must attend for anyone involved in the manufacture of biotech drugs in today’s fast changing environment. Building on the success of our previous...
Collaborative Data Analytics in the Biotech Industry
19 November 2018 - Biotech has a huge impact on our world. Biotech innovations provide novel treatments to cure diseases such as cancer and Alzheimer’s syndrome. Biotech brings new, sustainable products to the market. Biotech companies already conquer the world’s beef and...
How to Scale Lab Cell Therapy Process to cGMP Manufacturing
14 November 2018 - There is a paradigm shift occurring in the biomanufacturing space around the advancement of personalized medicine that is creating new challenges for biomanufacturing facility design, both in terms of process technology and facility development...
What's Next for Biopharma Manufacturing?
9 August 2018 - When the human genome was fully mapped in 2003, a futuristic concept of personalized medicine materialized. Medicine based on a person’s unique genetic make-up was not just a holy grail, now it was a REAL possibility. Over the past 15 years,...
12 September 2018 - New terms in the biopharma realm rarely surprise us but keeping up with the technology and the means of manufacturing can often be challenging. What I really enjoy about ISPE is the way they bring these new technologies to life allowing us to learn...
New Technologies & Molecules: Ready for the Future of Biologics Manufacturing?
27 August 2018 - If you want to prepare yourself for the next 10 years of your career, then I invite you to join me at this year's 2018 ISPE Biopharmaceutical Manufacturing Conference, 10 -12 December, Huntington Beach, California, a conference focused on a fascinating...
Clinical to Product Launch
Managing a treatment’s journey from the clinic to product launch requires planning and coordination across every function. The exciting new modalities and processes introduce new challenges that must be integrated with past experiences to achieve success. Case studies highlighting the success factors and lessons learned will be a great value to attendees, as will insight into managing manufacturing resources (internal vs external), and the challenges and benefits of collaborating with CDMO’s.
Regulatory/CMC/GMP/QA/Validation
With advances in ATMP technology, novel therapies and personalized medicines (such as Car T, ADC, and cancer vaccines), the approach to quality management, assurance, in-process controls and validation needs to evolve from the traditional batch-based controls to an approach that is not only risk based, but likely individually focused on the therapy and the patient. Conference attendees will have an opportunity to hear from current industry leaders on the various approaches taken, critical success factors for global acceptance and lessons learned along the way. Regulators will provide their perspective and experiences on assessing the right level of data and controls focused on the science while still in line with the principles of cGMP.
Cost
Cost pressures continue to increase within the pharmaceutical industry that put demands upon technical operations. Industry professionals are faced with being Flexible and Agile, always supporting the patients, but with a caveat that it is not at any cost and often must be rationalized for year on year cost benefit. Lean and Manufacturing Excellence processes have been deployed to drive the group to the most efficient point and routing out waste in every nook possible. How can these new modalities and manufacturing technologies be efficiently and sustainably manufactured? What are the two sides to the coin; unique challenges they introduce, and promising solutions they present?
Facilities, Equipment, and Processes
Facility designs for new modalities emerging from research will present different challenges than typical mAb facilities. Reduced scale, multiple concurrent batches, unique and stringent contamination challenges will require a rethinking of how to safely and reliably house the processes for these new treatments. Process intensification continues to move mAb manufacturing towards fully continuous biologics manufacturing with a resulting dramatic change in facility size, cost, and operating paradigms. Antibody Drug Conjugates and Oligonucleotide manufacturing introduce potent compound and solvent management challenges that may be unfamiliar to typical large molecule staff.
Supply Chain
The future state of biomanufacturing will require new and higher levels of supply chain logistics and control. Personalized medicine (e.g. CAR-T) present unique chain of custody, chain of identity, and transportation logistics challenges. Hospital operations need to be integrated into a compliant raw material supply and drug delivery system. Specialized delivery services to deliver time-and temperature-sensitive products consistently and safely will be key elements of a robust and low-risk supply chain.
Who Should Attend
- Bio Site Directors and above
- Operations managers
- Manufacturing, Quality Control and Quality Assurance heads
- Procurement professionals
- Engineering and Facility management heads
- Contract Manufacturing interface heads
- Key supply chain interfaces such as GE, Fisher et al
- Process sciences, process development heads
- Global Regulatory Authorities involved in (BLA, PAI, New Technologies)
Program Committee
........ PRESENTATION HANDOUTS ........
The conference presentations are available for download by conference attendees.
........ ATTENDEE ROSTER ........
See who is attending the 2018 ISPE Biopharmaceutical Manufacturing Conference by downloading Attendee Roster.
Featured Speakers
Raj K. Puri, MD, PhD, oversees the evaluation, regulation and approval of cell and gene therapy and tissue engineered medical products. Dr. Puri also performs FDA's mission-relevant medical research to advance medical product development; in
Tim Moore has more than three decades of leadership experience in biopharmaceutical manufacturing and operations. Most recently, he served as Senior Vice President, Head of Global Technical Operations – Biologics of Genentech, Inc. and as a member of
Dr. Juan Torres is Senior Vice President of Global Quality for Biogen. In this capacity he has worldwide responsibility over Corporate Quality, Quality Control, IT Quality, and Quality Operations at all Biogen production sites. He has been with
Patricia F. Hughes received a Ph.D. in Microbiology from Georgetown University and is currently the Branch Chief of Branch IV in the Division of Microbiology Assessment, Office of Process and Facilities, Office of Product Quality in CDER/FDA. This
Antonio (Tony) R. Moreira, PhD is Vice Provost for Academic Affairs at the University of Maryland, Baltimore County (UMBC) and is responsible for academic affairs matters within the Provost’s Office. In addition to his administrative responsibilities
Event Sponsors
