2022 ISPE Biotechnology Conference
Ways to Engage
Live streamed, On demand, Facility Tours, Deep dive training, & More
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keynote Speakers
Learn from industry experts.
Juan Andres, Narendra B. Bam, Ph.D., & Peter Marks, M.D., Ph.D.
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Showcase your solutions and services in front of key industry decision-makers.
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Conference Overview
2022 ISPE Biotechnology Conference will bring together leading pharmaceutical and biopharmaceutical manufacturers, technology providers, academic scientists, and international regulators to network, share insights, and provide an outlook on the evolving landscape and future of Biopharmaceutical manufacturing and therapeutics.
This conference will focus on themes to Level Up Agility in the New Normal! We will highlight what’s in store for the future of biopharmaceutical manufacturing, examining how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes. Dive into exciting interactive sessions and tracks specially designed for manufacturing leaders, technical experts/scientists, and early career professionals.
No matter what your area of focus is, you are sure to come away with tangible, practical solutions to improve your operations and standing within your company. Join us and be energized by the exciting opportunities offered by this biotechnology/biopharmaceutical program and register today.
Featured Keynote Speakers
Conference Content Areas
- Applications of mRNA Technologies
The outbreak of COVID-19 brought the mRNA technology to light. It went from being a silent long-term technology that need to prove its potential, well behind other new technologies like C&G therapies, to focus all the attention. Lead by Moderna, BioNTech and CureVac the number of players in this field is growing rapidly. New starts-up as well as establish pharmaceutical companies are now turning to mRNA. But what are the applications for mRNA technology beyond the COVID-19 vaccine that creates so much interest? The goal of the track is to learn on the potential of mRNA applications from vaccines to personalized medicines and beyond as a catalysator for such transformation.
- ATMPs/C>s: Data Science and R&D
ATMPs and/or C>s when applied to the world of Research and Development and Data Science require specific approaches compared to its manufacturing counterpart. Due to the small processing volumes, a Scale Out approach is implemented over a Scale Up approach. Unlike Mab therapy that begins from a Working Cell Bank, ATMPs begin with the patient itself and the variability of the starting material is what characterizes the uniqueness behind personalized medicine. The R&D efforts for ATMPs are focused on a five-dimensional framework where the “five R’s” incorporates notions regarding the right target, the right tissue, the right safety, the right patients, and the right commercial potential.
This track invites the attendees to explore novel and collaborative methods to achieve a consistent robust process when it comes to developing a sustainable, scalable manufacturing platform. Improvements in smart manufacturing of ATMPs supported by AI tools, digitalization and data science are key drivers to scientific, technical and operational progress. Coupled with non-invasive sensors for process monitoring along with dynamic contamination control strategies, the pathway from bench scale to market through smart manufacturing of ATMPs becomes a more tangible reality.
- ATMPs/C>s: Projects and Commercial Manufacturing
The quality attributes of advanced therapy medicinal products (ATMPs) that correlate with safety and efficacy in patients are determined not only by manufacturing process inputs such as starting and raw materials, but also by how the manufacturing process itself is designed and controlled. To ensure regulatory compliance, the manufacturing process should therefore be developed based on thorough characterization of the ATMP during all stages of process and analytical development; this ensures that the critical quality attributes that correlate with safety and efficacy are identified and that their specifications can be met during routine manufacturing. This track will include presentations exemplifying design, manufacturing and operation of these type commercial manufacturing of medicinal products.
- Enabling Digital Transformation(s) in Biotech
With rapid advancements in data infrastructure and tools, the Biomanufacturing Industry is implementing new technologies and ways of working to accelerate the delivery of complex biotherapeutics to patients. These digital data transformations require connectivity between highly skilled SMEs in facilities design, equipment selection and validation, technology transfer, manufacturing operations, Quality Assurance, and Regulatory Authorities. This track invites case studies demonstrating the details and value of such digital transformations, including program acceleration, advanced data modeling, rapid technology transfer, enhanced operational readiness, and data-enhanced regulatory submissions.
- Operations Readiness, Technology Transfer, & Risk based Case Studies
The Biomanufacturing Industry has during the last years risen to a number of challenges related to supply chain, drug shortages, and global deployment of manufacturing capabilities in connection with the new geopolitical map and current market needs. We have successfully introduced new ways of working and collaborating between industry and regulatory agencies starting with development and clinical trials and ending at the patient’s side. This track will give examples of ways of working that has proven beneficial for these processes and highlight how we can continue to develop our ways of working and communication channels to further improve the global reach of our products to meet the patient’s needs. Operational readiness and a focus on reducing environmental impact as well as other areas of sustainability are important factors to further this area of production in a responsible way. The work we do now gives us an excellent opportunity to keep those aspects in everything from design for new as well as retrofitted facilities, drug formulation, and logistics solutions
- Process Intensification
There has been a desire for increased efficiency in the manufacturing process to produce therapies with smaller markets. Adoption of new technologies and methodologies can allow for such an evolution of manufacturing under the rubric of process intensification. There are various instances of implementation of process intensification in the biopharmaceutical industry. This session will tell successful stories of several companies using this approach.
Conference Highlights
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iSpeak BlogDigital transformation has been growing in importance and urgency as the biopharma and biotech industry, manufacturers, and service providers seek to accelerate build-out of facilities and manufacturing processes in support of advanced biotherapeutics. -
iSpeak BlogThe 2022 ISPE Biotechnology Conference on June 28-30 in Boston, MA and virtually will offer attendees several unique perspectives and case studies across several separate content areas. -
iSpeak BlogThe 2022 Planning Committee is delighted to welcome attendance and registration for the fast-approaching ISPE Biotechnology Conference, taking place 28-30 June in Boston, Massachusetts and virtually.
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ISPE Safety Precautions
New and robust risk mitigation measures are being undertaken to instill public confidence in the safety of ISPE’s in-person events. In conjunction with the venues and vendors supporting our events, we are committed to the proper implementation of CDC, state, and local public health guidelines to ensure protective measures are in place to help mitigate the spread of COVID-19. Included are the measures ISPE will implement in accordance with the guidelines from the state and local authorities.
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