Conference: Alternative and Rapid Microbiological Methods

Objectives

Within the framework of this conference, current developments in regulatory requirements and scientific methodologies will be presented. Particular emphasis will be placed on experiences with the implementation and validation of alternative and rapid methods, both for in-process control and for product release testing. In addition, examples of real-time and online monitoring will be regularly addressed. The conference offers a platform to discuss the latest technological advances as well as practical challenges and considerations in meeting regulatory expectations. Presentations by distinguished speakers from regulatory authorities, industry, and academia in the field of microbiological detection and identification will provide a comprehensive overview.

These topics are driven by rapid scientific progress in cell and molecular biotechnology, which has led to the accelerated development of biopharmaceuticals, tissue-engineered products, and advanced therapy medicinal products (ATMPs). In this context, ensuring the safety of these technologies and products is becoming increasingly critical. A key aspect of risk assessment and safety assurance is the potential contamination with microorganisms and mycoplasmas. Their reliable detection, prevention, and control through rapid and appropriate methods are therefore essential for maintaining product safety and quality.

Highlights

• Optimising of Rapid Methods like ATP Bioluminescence, 16S rRNA,
• Rapid Methods for special Cases like Radiopharmaceuticals
• Update on ISO 16140 – How to learn from other industries
• NGS – Opportunities and Experiences
• And more

Target Audience

The track is aimed at people working in the following areas:

• Representatives of the regulatory and authorisation authorities
• Specialists for biopharmaceutical manufacturing processes
• QA/QC personnel in the biopharmaceutical environment
• Laboratory staff involved in the development and routine use of bioassays/potency assays
• Project managers and outsourcing personnel
• Biologists, analytical chemists and biochemists
• Scientists from academic fields involved in the development of biopharmaceutical products

Moderators

Dr Michael Miller, Microbiology Consultants
Dr Ulrich Herber, Charles River Laboratories

 

Congress Registration

Early Bird Rebate: Register until 31 August 2026 and save 100 EUR per congress day.

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