New Technologies and Molecules - 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.
Call for Proposals and Posters Timeline:
1 May 2018
30 May 2018
21 May – 8 June 2018
By 15 June 2018
There is limited space for oral presentations. If your proposal is not accepted for oral presentation, you may be considered for a poster presentation. You will be advised in writing of the status of your proposal by June 15, 2018.
By submitting a proposal, you acknowledge that, if your proposal is accepted, your organization will support your attendance at the conference. Accepted Presenters are responsible for their own travel and accommodations and receive complimentary registration for the conference. Session Leaders and panelists (not also presenting as a speaker), co-presenters, and poster presenters are eligible for a 20% discount to the prevailing rate and your membership status at the time of registration.
Proposals Are Requested for the Following Topic Areas:
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.
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 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.
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.