Dr Marja Claassen, MSD, The Netherlands
Dr Jörg Degen, Eurofins BioPharma Product Testing Munich GmbH, Germany
Dr Sven M. Deutschmann, Roche Diagnostics GmbH, Germany
Dr Marcel Goverde, MGP
Alexandra Stärk, Novartis Pharma Stein, Switzerland
Dr Radhakrishna Tirumalai, USP
During this workshop, the following contents and questions should be addressed by presentations and panel discussions. Considering that, panelists from the fields Non-Sterile Products, Sterile Products, Combination Products as well as biopharmaceutical APIs will be on hand for the workshop.
In their Pharmacopeial Forum 39(4) in 2014, the USP published the draft of chapter <1115> “Bioburden Control of Nonsterile Drug Substances and Products”. The document outlines a risk-based approach to the control of potential contamination in non-sterile product manufacturing.
But “bioburden” is not only a topic of Non-Sterile Products. Annex 1 of the European GMP Guideline requires “The bioburden should be monitored before sterilisation. There should be working limits on contamination immediately before sterilisation, which are related to the efficiency of the method to be used. Bioburden assay should be performed on each batch for both aseptically filled product and terminally sterilised products.”
And last but not least, bioburden testing for medical devices made or used in the USA is governed by Title 21 of the Code of Federal Regulations and worldwide by ISO 11737.
The current developments determine us to address this topic in a special workshop session to look at this from various angles and provide you with information about the regulatory background and practical examples and strategies for bioburden control. Pharmacopoeial experts, representatives of pharmaceutical quality control and from testing laboratory will show you what the challenges of the bioburden control strategy are and how they implemented an adequate control in their companies.
This conference is of interest to professionals in microbiology from
Pharmaceuticals and Biopharmaceutical Companies
Academic Research Institutions
Contract Service Laboratories
who are involved in
Research and Development
Microbiological QA and QC
Topic: General Information
Bioburden control strategy dependent of the lifecycle phase of the product (so-called “Phase-appropriate control strategy”)
- Early clinical phase
- Late clinical phase
- Commercial phase
Test for “specified microorganisms” and / or “objectionable microorganisms”?
- Raw materials
- In-process-control samples
- Drug substance
- Drug Product
- Final Product
- Where is bioburden tested in processes?
- Predefinition of bioburden and/or endotoxins levels for raw materials
- Assessment of the presence / absence of “objectionable microorganisms” in your raw materials?
- What are the method in use: TAMC, TYMC, MPN, Any other bioburden testing method, Rapid micro methods
- Is it necessary to have a limited shelf life for ioburden samples?
- How to treat so called “missing bioburden” results ?
Topic: Deviation Management
- Predefined bioburden and / or endotoxins levels for your upstream / fermentation processes (if applicable) and downstream processes or for the whole process
- What will be preferred? A two-tiered-control system (warning and alert level) or a three-tiered control system (warning and alert level AND rejection level)?
- Methodologies in use to define the limits, e.g. How many data points are required to define the limits? Philosophy for new processes / new manufacturing processes without having experience of process capabilities
Topic: USP <1115> and USP<1229.3>
- Do you perform ID? If YES, when: each colony, only in case of an excursion of limits / level, What’s the preferred ID technique?
- Measures in case of an excursion of a limit?
- “Bioburden Control of Nonsterile Drug Substances and Products” – USP and Industrial View
- Bioburden Monitoring, USP<1229.3> applies to Sterile Products
- European Regulations
- USP<1115> Bioburden Control of Non-Sterile Drug Substances and Products
- USP <1115> Industrial Implementation
- Microbial Control Strategy for Biopharmaceutical Manufacturing
- Colony Counting and Bioburden of Combination Products : Norms, Differences and Case Studies
- Bioburden for Sterile Operations
- Bioburden Monitoring , USP<1229.3> applies to Sterile Products
- Bioburden for Sterile Operations
- Bioburden control strategy of non-steriles
- Assessment of Bioburden Excursions in Non-Sterile Biologics Manufacturing Processes