2022 ISPE Biotechnology Conference

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Ways to Engage

Live streamed, On demand, Facility Tours, Deep dive training,  & More
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Technical Presentation

keynote Speakers

Learn from industry experts.
Juan Andres, Narendra B. Bam, Ph.D., & Peter Marks, M.D., Ph.D.
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Technical Presentation

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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.


What to Expect


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.


    David Estape, PhD
    Technology Manager Biotechnology
    CRB Group
    Vivianne J. Arencibia
    Vice President, Global Quality Systems and Compliance
    Moderna
  • ATMPs/C&GTs: Data Science and R&D

    ATMPs and/or C&GTs 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.


    Christoph Herwig, PhD
    Professor
    Vienna University of Technology
    Laura-Ann Shaa Ling Chin, BSc, MSc, PE
    Senior Process Engineer
    Genesis AEC
    Antonio R. Moreira, PhD
    Vice Provost, Academic Affairs
    University of Maryland
  • ATMPs/C&GTs: 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.


    Richard Denk
    Senior Consultant Aseptic Processing & Containment
    SKAN AG
    Robert Dream, PE, CPIP, PhD
    Managing Director
    HDR COMPANY LLC
  • 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.


    Phillip R. Smith, PhD
    Director, Process Technology
    GlaxoSmithKline
    Michelangelo Canzoneri
    Global Head of Digital and Data, Healthcare
    Merck Healthcare KGaA, Darmstadt, Germany
    Prudence Edwards
    Double Degree Engineering Student (University of Queensland/Centrale Marseille)
  • 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


    Ylva Ek
    Chief Quality Officer (CQO)
    KeyPlants AB
    Ralf Kretzschmar
    CEO
    Belimed Life Science AG
  • 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.


    David Doleski
    Head of Global Quality Audit and External Engagement
    Sanofi
    Tanya Sharma
    Partner At Assurea, Steering Committee Women in Pharma
    Assurea, LLC

Conference Highlights


Media Partners


Program Committee

Robert Dream, PE, CPIP, PhD
Managing Director
HDR COMPANY LLC
Co-Chair
Ralf Kretzschmar
CEO
Belimed Life Science AG
Co-Chair
Antonio R. Moreira, PhD
Vice Provost, Academic Affairs
University of Maryland
Ylva Ek
Chief Quality Officer (CQO)
KeyPlants AB
David Estape, PhD
Technology Manager Biotechnology
CRB Group
David Doleski
Head of Global Quality Audit and External Engagement
Sanofi
Phillip R. Smith, PhD
Director, Process Technology
GlaxoSmithKline
Prudence Edwards
Double Degree Engineering Student (University of Queensland/Centrale Marseille)
Michelangelo Canzoneri
Global Head of Digital and Data, Healthcare
Merck Healthcare KGaA, Darmstadt, Germany
Christoph Herwig, PhD
Professor
Vienna University of Technology
Laura-Ann Shaa Ling Chin, BSc, MSc, PE
Senior Process Engineer
Genesis AEC
Richard Denk
Senior Consultant Aseptic Processing & Containment
SKAN AG
Stephan Huelber
Process Engineer
VTU Engineering GmbH
Tanya Sharma
Partner At Assurea, Steering Committee Women in Pharma
Assurea, LLC
Women in Pharma® Liaison
Vivianne J. Arencibia
Vice President, Global Quality Systems and Compliance
Moderna
Board Liaison
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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