2018 ISPE Biopharmaceutical Manufacturing Conference

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.

Join us in December in beautiful Huntington Beach, CA to discover more about these aspects of Biopharmaceutical Manufacturing.

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

Andre L. Walker, CPIP
Andre L. Walker, CPIP
Principal
Andre Walker Consulting
Darren Dasburg
Darren Dasburg
Vice President and Site Head, Boulder Manufacturing Center
AstraZeneca
Robert Dream, PE, CPIP
Robert Dream, PE, CPIP
Principal
HDR Company LLC
Jeffery Odum, CPIP
Jeffery Odum, CPIP
Managing Partner, Strategic Mfg
NNE
Vivianne Arencibia
Vivianne Arencibia
VP and Global Head, External Engagement for Novartis Group QA
Novartis
Antonio Moreira, PhD
Antonio Moreira, PhD
Vice Provost
University of Maryland, Baltimore County
Joe Famulare
Joe Famulare
Vice President, Global Quality Compliance and External Relations
Genentech, Inc.