Vaccines - Advantages & Challenges in Manufacturing

Objectives

The development and production of vaccines places high demands on the manufacturing pharmaceutical industry. The special requirements for handling and safety with living organisms require measures that go beyond the requirements of classical drug production. This conference track is aimed at all those who develop, manufacture, release vaccines and deal with regulatory issues. Experienced speakers from the field of vaccines will explain the current requirements, share their knowledge of new innovative achievements, report on their experiences and implementation in the company.

Registration

Background

"Vaccines are expected to be very safe" is one of the headlines in the presentation by CBER's Vaccine safety team. At the same time, many vaccines are being developed and new vaccines are still needed for diseases for which no vaccine is currently available, and production technologies need to be improved to produce high-quality and, above all, patient-safe product. This has led to the emergence of new technologies, approaches and guidelines.
Through Corona, we have realized the importance of rapid development with subject matter expertise, as well as then manufacturing to the latest technology and requirements. Regulatory hurdles, batch release, audits and purification are a few of the many issues that can complicate the supply and production of vaccines.
The applications of vaccines seem limitless, but the implementation often fails. The typical questions often come up:

  • What are the official requirements, that I have to implement?
  • How can I implement this cost-effectively and as quickly as possible?
  • How can I produce permanently with consistent quality and still improve my process?

Target Audience

This conference is aimed at all persons who

  • are involved in the development and manufacturing of vaccines
  • responsible persons from quality assurance and control
  • are responsible for microbiological or analytical testing
  • audit vaccine manufactures
  • deal with authorisations

Detailed Programme

Tuesday, 19 March 2024

Global Progress in Vaccine Development: Regulatory Considerations and Scientific Advances
Dr Mohamad Toutounji, Molgenium

  • Evolution of Global Vaccine Regulations
  • Challenges and Opportunities in Vaccine Access
  • The Future of Vaccine Research and Development
  • Implementing Vaccination Programs Worldwide

Modern Vaccines – Perspective from the Regulatory Authority
Petra Falb, AGES – Austrian Agency for Health and Food Safety

  • Changing regulatory Requirements for latest Technologies
  • Regulatory Challenges – from conventional Antigens to Platforms
  • User-related Technology Examples – RNA Vaccines / DNA Vaccines / Vector Vaccines

Added Value by Advance Formulations for Vaccines?
Dr Sabine Hauck, Leukocare

  • Selection of smart methods to assess stability during formulation development
  • Advanced formulations - case studies
  • Potential of stability prediction

Low-Energy-Electron Irradiation – a potential Game Changer for the Development of Vaccines and Cell Therapies
Dr Andrea Traube, KyooBe Tech

  • Explanation of low-energy electron irradiation (LEEI)
  • Advantages compared to conventional methods
  • Application in cell therapy and development of vaccines

Resolving Facility Design Conflicts between Biocontainment & Good Manufacturing Practices for Vaccines Manufacture
Faye Litherland, Blue Sky Process Engineering

  • Facility location and layout
  • Heating, Ventilation and Air Conditioning (HVAC)
  • Construction methodology
  • Utility supply

The Search for efficacious and sustainable Alternatives to Triton™ X-100 in Therapeutics
James Humphrey, Croda Pharma

  • An overview of the technical and regulatory challenges of finding suitable alternatives to Triton™ X-100
  • Utilising structural characteristic and performance relationships to identify appropriate candidates to replace Triton™ X-100 in therapeutics
  • Demonstrating the application performance of Triton™ X-100 alternatives for vaccine, biotherapeutic protein and gene therapy applications

Wednesday, 20 March 2024

Vaccine Lot Release – Regulatory Aspects
Alya Aldahash, SFDA

  • WHO guidance for Vaccine lot realms for national regulatory authorities
  • Summary lot protocol
  • Trend analysis and monitoring
  • What the regulators expect from the manufacturer

Batch Release of Vaccines
Dr Alexander Bachmann, Pharmaceutical Consultancy Dr Bachmann

  • Batch release of IMP vaccines
  • Batch release of authorized vaccines

Modern Vaccines – GMP Inspector's View
Dr Frank Sielaff, Hessian State Office Of Health and Care, Darmstadt, Germany

  • Regulatory Guidelines
  • Specific Aspects for modern Vaccines
  • GMP-Inspections in Vaccine Production

Considerations for Cleaning Lipid Nanoparticles
Cecilia Pierobon, STERIS Life Sciences

  • Application and advantages of Lipid Nanoparticles (LNP)
  • Hurdles with cleaning of LNP
  • Case Study: General cleaning recommendation based on laboratory and field testing

USP Approach to mRNA and Viral Vector Vaccines
Nikhil Rautela, USP

  • mRNA and Viral Vector Draft Guideline updates
  • Toolkit
  • Other vaccine resources at USP

mRNA as API and as Part of LNP Structure
Dr Natalia Markova, Malvern Panalytical

  • Developability challenge with nucleic acid-based drugs
  • Light-scattering and calorimetric techniques as fit-for-purpose analytics
  • Informing on structure-function relationship
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