The 2019 ISPE Biopharmaceutical Manufacturing Conference focuses on innovation in production methods and technologies that enable a competitive and sustainable biopharmaceutical product supply for the future.
From Monoclonals to viral vectors, oligos to ADCs, this conference will bring together experts that are developing, implementing, and operating advanced supply chains supplying high quality medicines to global markets.
The 2019 Conference Program Committee invites you to submit a proposal and share your expertise with other experts and leaders to ensure the Biomanufacturing industry successfully prepares to deliver on our promise of supplying life changing medicines to patients across the globe for years to come.
|Call for Proposals and Posters Timeline|
|Review||1 February – 1 March|
Efficient operations, high success rate, and maximum utilization are requirements for a profitable and sustainable manufacturing infrastructure to meet our global commitment to patients and society. These attributes can be achieved through a myriad of means. Process intensification, rapid bioburden measurement, PAT and soft sensors, continuous processing, are just a few examples. Case studies highlighting substantial increases in output, quality, or dramatic reduction in cost and risk, will be a great value to attendees facing similar challenges.
Emerging Cell and Gene therapies dramatically change the ecosystem in which treatments are developed, tested, and commercialized. When one batch treats only one patient, or a single dose provides lasting therapy, the development process, clinical trials, and manufacturing process are simultaneous. Many face the decision between centralized manufacture and bedside preparation, and the development of these treatments at research hospitals further challenges our industry norms. Presentations on navigating this new pathway are requested from small and large firms alike as well as from academia and research hospitals.
Innovation in single use closed systems has enabled facility designs that challenge old norms of segregation and room classification. Process intensification has also created opportunities for semi-continuous operation. Harvesting the benefits from these innovations requires manufacturers and regulators to work together to insure a safe and reliable drug product supply. Presentations are requested that present novel facility designs and manufacturing technologies that forge new norms for the industry, as well as the Quality Systems and Regulatory approaches that enabled their adoption.
Oligos and ADC’s are cousins to traditional biopharma, leveraging the therapeutic power of antibodies and nucleic acid, but introducing manufacturing challenges more typical to small molecule production. Potent compound management is critical to ADC’s, and competency in solvent handling is necessary for Oligo production, yet typical biopharma organizations developing these treatments have little experience with such challenges. Presentations are requested by those who have successfully navigated this supply chain, be it through CDMOs, and/or internal production.
Many new modalities are being developed by small firms without internal manufacturing capabilities. This has created a shortage of CDMO capacity, especially in non-traditional biopharma processes such as ADC, Oligo, and Viral Vectors. Presentations are requested from CDMO’s and their clients on best practices in navigating this challenging supply situation. Examples might be excellence in tech transfer practices, development of platform processes, or business arrangements to share or minimize risk.
Personalized medicine (e.g. CAR-T) present unique chain of custody, chain of identity, and transportation logistics challenges. Bedside and hospital lab 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.
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