Conference: Alternative and Rapid Microbiological Methods

Objectives

This conference will review the current knowledge about developments in modern microbiological methods and mycoplasma detection strategies for quality control in biopharmaceutical manufacturing.

This one-day conference provides the opportunity to discuss the recent advances in the area of the newest technological developments as well as practical aspects and concerns of meeting the regulatory requirements. State-of-the-art presentations from authority speakers, as well as industrial and academic experts in the field of microbiological detection and identification and mycoplasmology with particular focus on the current methodologies their implementation and validation will provide an in-depth overview.

Background

The scientific progress in the field of cellular and molecular biotechnology led to a fast development of biopharmaceuticals, tissue engineered applications and advanced therapy medicinal products (ATMPs). Against this background, the safety of such new technologies, products and applications becomes more importance. One important topic in the focus of risk assessment and safety is the contamination with microorganisms and mycoplasmas and their detection, prevention and control.

Target Audience

This conference is of interest to professionals from

• Biotechnological & Biopharmaceutical Companies
• Contract Service Laboratories
• Academic Research Institutions and Organizations
• Government Agencies
• Cell Culture Collections
• Supplier Detection Systems

with responsibilities in

• Manufacturing
• Quality Assurance
• Quality Control
• Regulatory Affairs
• Research & Development
• Process Development
• Validation

09.15 - 10.00 h
Congress Keynote: Biological Manufacturing – Demanding Quality and Compliance Requirements
Dr Tilman Rock, SVP, Site Head Vienna (Austria), Boehringer Ingelheim Biopharma

Game Changer? Use of Rapid Microbiological Methods (RMM) in the GMP - Quality Control Lab
Dr Philipp Kucera, VelaLabs

Next Generation Sequencing: Current Trends and Perspectives for Pharma and Biotech
Dr Inanc Deger Erserim, Thermo Fisher

MS for ID - Regulatory Changes and their Influence of ID in Laboratory
Dr Gerold Schwarz, Bruker

New Solid Phase Cytometry Method
Dr Wilfried Ablain, Microbs

Case Studies on Burkholderia Cepacia Complex (BCC) Investigations, QC Lab Testing and Remediation
Dr Michael Miller, Microbiology Consultants

ATP Bioluminescence for Non-sterile Product Testing: Roadmap to Implementation
Inge van der Schoot, J&J

Novel Automated Rapid Sterility Test
Dr David Jones, RMB

Non-inferiority Testing for Qualitative Microbiological Methods: Assessing and improving the Approach in USP <1223>
Dr Pieta IJzerman-Boon, MSD

Moderation

Dr Sven M. Deutschmann, Roche

Speakers

Dr Wilfried Ablain, Microbs, France. CEO.

Dr Inanc Deger Erserim, Thermo Fisher, Germany. Senior Product Specialist NGS.

Dr Pieta IJzerman-Boon, MSD, The Netherlands. Principal Statistician.

Dr David Jones, RMB, USA. Director Industry Affairs.

Dr Philipp Kucera, VelaLabs, Austria. Quality Assurance Officer.

Dr Michael Miller, Microbiology Consultants, USA. President.

Dr Gerold Schwarz, Bruker, Germany. Manager Application Support.

Inge van der Schoot, J&J, The Netherlands. SME MIcrobiology.