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The BioPharm International and Pharmaceutical Technology editors host industry experts, highlighting trends and new technologies.
INTERPHEX will be held in person at the Javits Center, October 19–21, 2021, and—to continue a long-standing tradition—the editors of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International will moderate Keynote Sessions featuring industry experts. Unique to this year, however, the sessions will be premiered by video on the show floor. Come to the Innovation Stage to watch the following presentations.
Equipment Trends in Advanced Solid-Dosage Drug Manufacturing
Tuesday, Oct. 19, 2021, 10:15 am–noon EDT
Equipment and advanced manufacturing approaches to meet the evolving needs for solid-dosage drugs include continuous manufacturing, containment strategies, Industry 4.0 tools, and techniques for optimizing solid dosage form manufacturing. This session will call on industry experts to address the practical approaches, techniques, equipment, and tools needed to adopt these strategies, as well as considering trends and developments for improving quality and operational efficiency. The session will be moderated by Jennifer Markarian, manufacturing editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.
Hear insight from industry experts:
Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies
Tuesday, Oct. 19, 2021, 1:15–3 pm EDT
The progression of increasingly complex biological molecules in early drug development poses unique challenges to their analytical characterization, which, in turn, impacts the design and approach of biomanufacturers to the bioprocesses needed to produce these molecules, both in the lab and at scale up/scale out. This session will explore current advances in analytical methodologies and equipment starting at the benchtop and carrying through to process analytics and process development. The session will be moderated by Feliza Mirasol, science editor, BioPharm International, Pharmaceutical Technology, and Pharmaceutical Technology Europe.
Hear from industry experts:
Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD
Wednesday, Oct. 20, 2021, 10:15 am–noon EDT
With the deadline for complying with the aggregation requirements of the US Drug Supply Chain Security Act (DSCSA) two years away and uncertainties about authentication of medicines in a post-Brexit Europe, questions about compliance—and the security of the drug supply—are at the forefront. In this discussion, global supply chain experts examine implications of the DSCSA’s Nov. 27, 2023, aggregation compliance deadline and topical considerations around the European Union’s (EU) Falsified Medicines Directive (FMD).
As the aggregation compliance for the DSCSA—delayed from 2019—approaches, what do companies across the bio/pharmaceutical supply chain need to tackle now, and what can they expect going forward?
Within Europe, compliance with the delegated EU FMD regulation has been required since 2019. However, implementation of the delegated regulation has not been smooth sailing. In what position has Brexit left stakeholders with regards to medicines authentication? Has it been/might it be necessary to further update manufacturing and packaging lines to accommodate variances in regulations?
Experts from across the global supply chain will provide insight and answers to these questions:
The Evolution of Aseptic Processing
Wednesday, Oct. 20, 2021, 1:15 pm–3 pm EDT
The technical demands of aseptic processing have long challenged pharmaceutical companies and contract manufacturers to produce different volumes of safe, effective, drugs in a cost-effective manner. Drug recalls and regulatory actions have underlined the technical and regulatory hurdles. In this keynote session, experts in aseptic processing will discuss the evolution of their field, including specifics on what might be required to transform existing processing lines to comply with new regulatory requirements, the variety of challenges and new solutions available to deal with small-batch processing, and the application of single-use systems and associated issues, such as shortages and sterilization difficulties. This session will be moderated by Felicity Thomas, European editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.
Hear insight from consultants, academic experts, representatives from industry associations, and technical experts from companies supporting aseptic processing:
To register for the show and the complimentary conference sessions on the show floor, go to www.INTERPHEX.com .